Trial Outcomes & Findings for Improvisational Movement for People With Memory Loss and Their Caregivers (NCT NCT03333837)

NCT ID: NCT03333837

Last Updated: 2022-07-27

Results Overview

Self-reported quality of life in the person with dementia is the primary outcome and will be measured using the QOL-AD . The QOL-AD is validated for use in people with Mini Mental State Exam scores as low as 10.The QOL\_AD contains 13 items.Points are assigned to each item as follows: poor = 1, fair = 2, good = 3, excellent = 4.The total score is the sum of all 13 item (range 13- 52) higher scores represent better outcomes.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

104 participants

Primary outcome timeframe

Baseline

Results posted on

2022-07-27

Participant Flow

All Persons With Dementia (PWDs) were enrolled with one caregiver each. There was never a time when one was enrolled without the other, so these two people are represented in the participant flow as a dyad.

Participants were enrolled in dyads consisting of one person with dementia (PWD) and one caregiver (CG). Participant flow section includes numbers as dyad since both were considered enrolled. Elsewhere in the record, numbers include either participants with dementia or caregivers as indicated in baseline analysis population description and in outcome titles or descriptions.

Participant milestones

Participant milestones
Measure
Dance Group
The Dance Group will participate in 1-hour group improvisational dance lessons 2x/week for 12 weeks. Improvisational dance classes are grounded in 4 principles that shape the tone of the class and result in a sense of social belonging: non-judgment, non-competitiveness, curiosity, and playfulness. The following training strategies are used to maintain: active imagination, variability, and pacing. Dance Group: Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem.
Non-group Dance
The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week. Non-Group Dance: The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise.
Social Group
The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. Social Group: The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader.
No Contact
A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks No Contact: The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like.
Never Randomized
Subject dyads who signed consent but withdrew prior to randomization.
Overall Study
STARTED
24
25
27
25
3
Overall Study
COMPLETED
22
22
22
23
0
Overall Study
NOT COMPLETED
2
3
5
2
3

Reasons for withdrawal

Reasons for withdrawal
Measure
Dance Group
The Dance Group will participate in 1-hour group improvisational dance lessons 2x/week for 12 weeks. Improvisational dance classes are grounded in 4 principles that shape the tone of the class and result in a sense of social belonging: non-judgment, non-competitiveness, curiosity, and playfulness. The following training strategies are used to maintain: active imagination, variability, and pacing. Dance Group: Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem.
Non-group Dance
The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week. Non-Group Dance: The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise.
Social Group
The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. Social Group: The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader.
No Contact
A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks No Contact: The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like.
Never Randomized
Subject dyads who signed consent but withdrew prior to randomization.
Overall Study
Adverse Event
2
1
1
1
0
Overall Study
Caregiver withdrew
0
2
1
0
0
Overall Study
Withdrawal by Subject
0
0
1
1
3
Overall Study
COVID interrupted enrollment--had to rescreen and didn't qualify
0
0
2
0
0

Baseline Characteristics

Improvisational Movement for People With Memory Loss and Their Caregivers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Dance Group
n=24 Participants
The Dance Group will participate in 1-hour group improvisational dance lessons 2x/week for 12 weeks. Improvisational dance classes are grounded in 4 principles that shape the tone of the class and result in a sense of social belonging: non-judgment, non-competitiveness, curiosity, and playfulness. The following training strategies are used to maintain: active imagination, variability, and pacing. Dance Group: Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem.
Non-group Dance
n=25 Participants
The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week. Non-Group Dance: The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise.
Social Group
n=27 Participants
The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. Social Group: The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader.
No Contact
n=25 Participants
A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks No Contact: The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like.
Never Randomized
n=3 Participants
Subject dyads who signed consent but withdrew prior to randomization.
Total
n=104 Participants
Total of all reporting groups
Age, Continuous
75.33 years
STANDARD_DEVIATION 5.94 • n=93 Participants
73.62 years
STANDARD_DEVIATION 7.10 • n=4 Participants
76.75 years
STANDARD_DEVIATION 6.29 • n=27 Participants
76.0 years
STANDARD_DEVIATION 6.43 • n=483 Participants
69.87 years
STANDARD_DEVIATION 3.23 • n=36 Participants
75.29 years
STANDARD_DEVIATION 6.45 • n=10 Participants
Sex: Female, Male
Female
12 Participants
n=93 Participants
13 Participants
n=4 Participants
14 Participants
n=27 Participants
11 Participants
n=483 Participants
0 Participants
n=36 Participants
50 Participants
n=10 Participants
Sex: Female, Male
Male
12 Participants
n=93 Participants
12 Participants
n=4 Participants
13 Participants
n=27 Participants
14 Participants
n=483 Participants
3 Participants
n=36 Participants
54 Participants
n=10 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
0 Participants
n=483 Participants
0 Participants
n=36 Participants
0 Participants
n=10 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
24 Participants
n=93 Participants
24 Participants
n=4 Participants
27 Participants
n=27 Participants
25 Participants
n=483 Participants
3 Participants
n=36 Participants
103 Participants
n=10 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=93 Participants
1 Participants
n=4 Participants
0 Participants
n=27 Participants
0 Participants
n=483 Participants
0 Participants
n=36 Participants
1 Participants
n=10 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
0 Participants
n=483 Participants
0 Participants
n=36 Participants
0 Participants
n=10 Participants
Race (NIH/OMB)
Asian
1 Participants
n=93 Participants
0 Participants
n=4 Participants
1 Participants
n=27 Participants
0 Participants
n=483 Participants
0 Participants
n=36 Participants
2 Participants
n=10 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
0 Participants
n=483 Participants
0 Participants
n=36 Participants
0 Participants
n=10 Participants
Race (NIH/OMB)
Black or African American
2 Participants
n=93 Participants
3 Participants
n=4 Participants
6 Participants
n=27 Participants
2 Participants
n=483 Participants
0 Participants
n=36 Participants
13 Participants
n=10 Participants
Race (NIH/OMB)
White
21 Participants
n=93 Participants
22 Participants
n=4 Participants
20 Participants
n=27 Participants
23 Participants
n=483 Participants
3 Participants
n=36 Participants
89 Participants
n=10 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
0 Participants
n=483 Participants
0 Participants
n=36 Participants
0 Participants
n=10 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
0 Participants
n=483 Participants
0 Participants
n=36 Participants
0 Participants
n=10 Participants
Region of Enrollment
United States
24 participants
n=93 Participants
25 participants
n=4 Participants
27 participants
n=27 Participants
25 participants
n=483 Participants
3 participants
n=36 Participants
104 participants
n=10 Participants

PRIMARY outcome

Timeframe: Baseline

Population: Results at baseline for this outcome represent all PWD who were randomized.

Self-reported quality of life in the person with dementia is the primary outcome and will be measured using the QOL-AD . The QOL-AD is validated for use in people with Mini Mental State Exam scores as low as 10.The QOL\_AD contains 13 items.Points are assigned to each item as follows: poor = 1, fair = 2, good = 3, excellent = 4.The total score is the sum of all 13 item (range 13- 52) higher scores represent better outcomes.

Outcome measures

Outcome measures
Measure
No Contact
n=25 Participants
A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks No Contact: The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like.
Dance Group
n=24 Participants
The Dance Group will participate in 1-hour group improvisational dance lessons 2x/week for 12 weeks. Improvisational dance classes are grounded in 4 principles that shape the tone of the class and result in a sense of social belonging: non-judgment, non-competitiveness, curiosity, and playfulness. The following training strategies are used to maintain: active imagination, variability, and pacing. Dance Group: Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem.
Non-group Dance
n=25 Participants
The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week. Non-Group Dance: The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise.
Social Group
n=27 Participants
The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. Social Group: The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader.
Quality of Life in Alzheimer's Disease (QOL-AD)--Participants With Dementia (PWD)
36.12 score on a scale
Standard Deviation 5.75
35.42 score on a scale
Standard Deviation 5.02
38.10 score on a scale
Standard Deviation 4.60
35.56 score on a scale
Standard Deviation 4.15

PRIMARY outcome

Timeframe: Week 12

Population: Overall number of participants analyzed corresponds to the number of participants who completed the study.

Self-reported quality of life in the person with dementia is the primary outcome and will be measured using the QOL-AD . The QOL-AD is validated for use in people with Mini Mental State Exam scores as low as 10.The QOL\_AD contains 13 items.Points are assigned to each item as follows: poor = 1, fair = 2, good = 3, excellent = 4.The total score is the sum of all 13 item (range 13- 52) higher scores represent better outcomes.

Outcome measures

Outcome measures
Measure
No Contact
n=23 Participants
A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks No Contact: The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like.
Dance Group
n=22 Participants
The Dance Group will participate in 1-hour group improvisational dance lessons 2x/week for 12 weeks. Improvisational dance classes are grounded in 4 principles that shape the tone of the class and result in a sense of social belonging: non-judgment, non-competitiveness, curiosity, and playfulness. The following training strategies are used to maintain: active imagination, variability, and pacing. Dance Group: Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem.
Non-group Dance
n=22 Participants
The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week. Non-Group Dance: The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise.
Social Group
n=22 Participants
The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. Social Group: The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader.
QOL-AD--PWD
35.96 score on a scale
Standard Deviation 8.04
35.23 score on a scale
Standard Deviation 6.54
40.0 score on a scale
Standard Deviation 5.36
36.68 score on a scale
Standard Deviation 4.76

SECONDARY outcome

Timeframe: Baseline

Population: Participants are missing at baseline imaging data due to an undisclosed contraindicated device, aborting scan, refusing scans, or excessive head motion.

This is a brain imaging variable derived from fMRI images. Modularity (Q) ranges from 0 (no community structure) to 1 (perfectly modular network). One Q-value is generated for each person and group averages are shown.

Outcome measures

Outcome measures
Measure
No Contact
n=21 Participants
A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks No Contact: The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like.
Dance Group
n=24 Participants
The Dance Group will participate in 1-hour group improvisational dance lessons 2x/week for 12 weeks. Improvisational dance classes are grounded in 4 principles that shape the tone of the class and result in a sense of social belonging: non-judgment, non-competitiveness, curiosity, and playfulness. The following training strategies are used to maintain: active imagination, variability, and pacing. Dance Group: Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem.
Non-group Dance
n=25 Participants
The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week. Non-Group Dance: The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise.
Social Group
n=23 Participants
The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. Social Group: The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader.
Community Structure--PWD
.74 Q-Value
Standard Deviation .04
.74 Q-Value
Standard Deviation .05
.72 Q-Value
Standard Deviation .05
.73 Q-Value
Standard Deviation .05

SECONDARY outcome

Timeframe: Week 12

Population: Numbers at baseline and week 12 differ due to withdrawals, poor data quality, and inability to complete scans.

This is a brain imaging variable derived from fMRI images. Modularity (Q) ranges from 0 (no community structure) to 1 (perfectly modular network). One Q-value is generated for each person and group averages are shown.

Outcome measures

Outcome measures
Measure
No Contact
n=19 Participants
A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks No Contact: The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like.
Dance Group
n=20 Participants
The Dance Group will participate in 1-hour group improvisational dance lessons 2x/week for 12 weeks. Improvisational dance classes are grounded in 4 principles that shape the tone of the class and result in a sense of social belonging: non-judgment, non-competitiveness, curiosity, and playfulness. The following training strategies are used to maintain: active imagination, variability, and pacing. Dance Group: Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem.
Non-group Dance
n=20 Participants
The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week. Non-Group Dance: The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise.
Social Group
n=18 Participants
The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. Social Group: The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader.
Community Structure--PWD
.75 Q-Value
Standard Deviation .03
.74 Q-Value
Standard Deviation .04
.73 Q-Value
Standard Deviation .05
.75 Q-Value
Standard Deviation .04

SECONDARY outcome

Timeframe: Baseline

Population: Participants are missing at baseline imaging data due to an undisclosed contraindicated device, aborting scan, refusing scans, or excessive head motion.

This is a brain imaging variable derived from fMRI images.Scale ranges from 0 (no long-range information processing) to 1 (maximal distributed processing). Decreased Eglob has been associated with aging, cognitive impairment, and depression.

Outcome measures

Outcome measures
Measure
No Contact
n=21 Participants
A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks No Contact: The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like.
Dance Group
n=24 Participants
The Dance Group will participate in 1-hour group improvisational dance lessons 2x/week for 12 weeks. Improvisational dance classes are grounded in 4 principles that shape the tone of the class and result in a sense of social belonging: non-judgment, non-competitiveness, curiosity, and playfulness. The following training strategies are used to maintain: active imagination, variability, and pacing. Dance Group: Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem.
Non-group Dance
n=25 Participants
The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week. Non-Group Dance: The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise.
Social Group
n=23 Participants
The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. Social Group: The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader.
Global Efficiency (eGlob)--PWD
.19 score on a scale
Standard Deviation .03
.19 score on a scale
Standard Deviation .02
.18 score on a scale
Standard Deviation .03
.19 score on a scale
Standard Deviation .03

SECONDARY outcome

Timeframe: Week 12

Population: Number at baseline and follow-up differ due to withdrawals, poor data quality, participant refusal of procedure, inability to complete scan.

This is a brain imaging variable derived from fMRI images.Scale ranges from 0 (no long-range information processing) to 1 (maximal distributed processing). Decreased Eglob has been associated with aging, cognitive impairment, and depression.

Outcome measures

Outcome measures
Measure
No Contact
n=19 Participants
A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks No Contact: The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like.
Dance Group
n=20 Participants
The Dance Group will participate in 1-hour group improvisational dance lessons 2x/week for 12 weeks. Improvisational dance classes are grounded in 4 principles that shape the tone of the class and result in a sense of social belonging: non-judgment, non-competitiveness, curiosity, and playfulness. The following training strategies are used to maintain: active imagination, variability, and pacing. Dance Group: Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem.
Non-group Dance
n=20 Participants
The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week. Non-Group Dance: The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise.
Social Group
n=18 Participants
The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. Social Group: The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader.
Global Efficiency (eGlob)--PWD
.19 score on a scale
Standard Deviation .03
.19 score on a scale
Standard Deviation .03
.18 score on a scale
Standard Deviation .03
.19 score on a scale
Standard Deviation .02

SECONDARY outcome

Timeframe: Baseline

Population: Participants are missing at baseline imaging data due to an undisclosed contraindicated device, aborting scan, refusing scans, or excessive head motion.

Scale ranges from 0 (no local connectivity) to 1 (maximal local connectivity - all connections are local) and has been observed to change with cognitive impairment and depression.

Outcome measures

Outcome measures
Measure
No Contact
n=21 Participants
A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks No Contact: The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like.
Dance Group
n=24 Participants
The Dance Group will participate in 1-hour group improvisational dance lessons 2x/week for 12 weeks. Improvisational dance classes are grounded in 4 principles that shape the tone of the class and result in a sense of social belonging: non-judgment, non-competitiveness, curiosity, and playfulness. The following training strategies are used to maintain: active imagination, variability, and pacing. Dance Group: Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem.
Non-group Dance
n=25 Participants
The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week. Non-Group Dance: The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise.
Social Group
n=23 Participants
The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. Social Group: The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader.
Local Efficiency (eLoc)--PWD
.58 units on a scale
Standard Deviation .04
.59 units on a scale
Standard Deviation .03
.57 units on a scale
Standard Deviation .04
.59 units on a scale
Standard Deviation .03

SECONDARY outcome

Timeframe: Week 12

Population: Number at baseline and follow-up differ due to withdrawals, poor data quality, participant refusal of procedure, inability to complete scan.

Scale ranges from 0 (no local connectivity) to 1 (maximal local connectivity - all connections are local) and has been observed to change with cognitive impairment and depression.

Outcome measures

Outcome measures
Measure
No Contact
n=19 Participants
A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks No Contact: The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like.
Dance Group
n=20 Participants
The Dance Group will participate in 1-hour group improvisational dance lessons 2x/week for 12 weeks. Improvisational dance classes are grounded in 4 principles that shape the tone of the class and result in a sense of social belonging: non-judgment, non-competitiveness, curiosity, and playfulness. The following training strategies are used to maintain: active imagination, variability, and pacing. Dance Group: Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem.
Non-group Dance
n=20 Participants
The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week. Non-Group Dance: The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise.
Social Group
n=18 Participants
The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. Social Group: The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader.
Local Efficiency (eLoc)--PWD
.58 units on a scale
Standard Deviation .04
.58 units on a scale
Standard Deviation .03
.58 units on a scale
Standard Deviation .03
.59 units on a scale
Standard Deviation .03

SECONDARY outcome

Timeframe: Baseline

Population: Participants are missing at baseline imaging data due to an undisclosed contraindicated device, aborting scan, refusing scans, or excessive head motion.

Refers to the number of edges that must be crossed to get from one node to another. Longer path length in people with AD has been associated with slower cognitive performance, beta amyloid deposition, and depression.

Outcome measures

Outcome measures
Measure
No Contact
n=21 Participants
A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks No Contact: The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like.
Dance Group
n=24 Participants
The Dance Group will participate in 1-hour group improvisational dance lessons 2x/week for 12 weeks. Improvisational dance classes are grounded in 4 principles that shape the tone of the class and result in a sense of social belonging: non-judgment, non-competitiveness, curiosity, and playfulness. The following training strategies are used to maintain: active imagination, variability, and pacing. Dance Group: Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem.
Non-group Dance
n=25 Participants
The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week. Non-Group Dance: The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise.
Social Group
n=23 Participants
The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. Social Group: The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader.
Path Length--PWD
5.52 Number of Edges
Standard Deviation .93
5.29 Number of Edges
Standard Deviation .58
5.69 Number of Edges
Standard Deviation 1.17
5.42 Number of Edges
Standard Deviation .78

SECONDARY outcome

Timeframe: Week 12

Population: Number at baseline and follow-up differ due to withdrawals, poor data quality, participant refusal of procedure, inability to complete scan.

Refers to the number of edges that must be crossed to get from one node to another. Longer path length in people with AD has been associated with slower cognitive performance, beta amyloid deposition, and depression.

Outcome measures

Outcome measures
Measure
No Contact
n=19 Participants
A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks No Contact: The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like.
Dance Group
n=20 Participants
The Dance Group will participate in 1-hour group improvisational dance lessons 2x/week for 12 weeks. Improvisational dance classes are grounded in 4 principles that shape the tone of the class and result in a sense of social belonging: non-judgment, non-competitiveness, curiosity, and playfulness. The following training strategies are used to maintain: active imagination, variability, and pacing. Dance Group: Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem.
Non-group Dance
n=20 Participants
The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week. Non-Group Dance: The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise.
Social Group
n=18 Participants
The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. Social Group: The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader.
Path Length--PWD
5.54 Number of Edges
Standard Deviation 1.09
5.30 Number of Edges
Standard Deviation .93
5.61 Number of Edges
Standard Deviation .80
5.36 Number of Edges
Standard Deviation .54

SECONDARY outcome

Timeframe: Baseline

Population: One participant is missing baseline data due to a recording error during data collection.

Fullerton Advanced Balance Scale (FAB) measures balance using 10 different performance-based tests (scored 0 worst - 4 best), including; standing with feet together and eyes closed, standing on a foam pad with eyes closed, walking while turning the head from side to side rhythmically, functional standing reach, turning around to the left and right, stepping up and over a 6-inch box, standing on one leg, and a test for postural reaction. The scale goes from 0-40 with 40 being the best outcome and a cutoff of \<=25 for risk of falls.

Outcome measures

Outcome measures
Measure
No Contact
n=24 Participants
A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks No Contact: The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like.
Dance Group
n=24 Participants
The Dance Group will participate in 1-hour group improvisational dance lessons 2x/week for 12 weeks. Improvisational dance classes are grounded in 4 principles that shape the tone of the class and result in a sense of social belonging: non-judgment, non-competitiveness, curiosity, and playfulness. The following training strategies are used to maintain: active imagination, variability, and pacing. Dance Group: Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem.
Non-group Dance
n=25 Participants
The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week. Non-Group Dance: The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise.
Social Group
n=27 Participants
The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. Social Group: The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader.
Fullerton Advanced Balance Scale (Overall Balance) PWD
26.79 score on a scale
Standard Deviation 4.57
23.71 score on a scale
Standard Deviation 8.22
27.88 score on a scale
Standard Deviation 5.40
24.22 score on a scale
Standard Deviation 6.32

SECONDARY outcome

Timeframe: Week 12

Population: Number at baseline and week 12 differ due to withdrawals.

Fullerton Advanced Balance Scale (FAB) measures balance using 10 different performance-based tests (scored 0 worst - 4 best), including; standing with feet together and eyes closed, standing on a foam pad with eyes closed, walking while turning the head from side to side rhythmically, functional standing reach, turning around to the left and right, stepping up and over a 6-inch box, standing on one leg, and a test for postural reaction. The scale goes from 0-40 with 40 being the best outcome and a cutoff of \<=25 for risk of falls.

Outcome measures

Outcome measures
Measure
No Contact
n=23 Participants
A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks No Contact: The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like.
Dance Group
n=22 Participants
The Dance Group will participate in 1-hour group improvisational dance lessons 2x/week for 12 weeks. Improvisational dance classes are grounded in 4 principles that shape the tone of the class and result in a sense of social belonging: non-judgment, non-competitiveness, curiosity, and playfulness. The following training strategies are used to maintain: active imagination, variability, and pacing. Dance Group: Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem.
Non-group Dance
n=22 Participants
The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week. Non-Group Dance: The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise.
Social Group
n=22 Participants
The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. Social Group: The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader.
Fullerton Advanced Balance Scale (Overall Balance) PWD
26.78 score on a scale
Standard Deviation 6.65
23.41 score on a scale
Standard Deviation 8.57
29.95 score on a scale
Standard Deviation 4.33
24.27 score on a scale
Standard Deviation 6.26

SECONDARY outcome

Timeframe: Baseline

A 16-item scale to assess fear of falling where higher scores reflect a higher fear and risk of falling. Out of a total score of 100, a score of 70 or above indicates the individual has a fear of falling.

Outcome measures

Outcome measures
Measure
No Contact
n=25 Participants
A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks No Contact: The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like.
Dance Group
n=24 Participants
The Dance Group will participate in 1-hour group improvisational dance lessons 2x/week for 12 weeks. Improvisational dance classes are grounded in 4 principles that shape the tone of the class and result in a sense of social belonging: non-judgment, non-competitiveness, curiosity, and playfulness. The following training strategies are used to maintain: active imagination, variability, and pacing. Dance Group: Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem.
Non-group Dance
n=25 Participants
The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week. Non-Group Dance: The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise.
Social Group
n=27 Participants
The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. Social Group: The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader.
Falls Efficacy Scale - International (FES) PWD
25.56 score on a scale
Standard Deviation 8.65
27.54 score on a scale
Standard Deviation 10.06
22.64 score on a scale
Standard Deviation 4.86
26.07 score on a scale
Standard Deviation 7.76

SECONDARY outcome

Timeframe: Week 12

Population: Overall number of participants analyzed corresponds to the number of participants who completed the study.

A 16-item scale to assess fear of falling where higher scores reflect a higher fear and risk of falling. Out of a total score of 100, a score of 70 or above indicates the individual has a fear of falling.

Outcome measures

Outcome measures
Measure
No Contact
n=23 Participants
A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks No Contact: The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like.
Dance Group
n=22 Participants
The Dance Group will participate in 1-hour group improvisational dance lessons 2x/week for 12 weeks. Improvisational dance classes are grounded in 4 principles that shape the tone of the class and result in a sense of social belonging: non-judgment, non-competitiveness, curiosity, and playfulness. The following training strategies are used to maintain: active imagination, variability, and pacing. Dance Group: Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem.
Non-group Dance
n=22 Participants
The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week. Non-Group Dance: The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise.
Social Group
n=22 Participants
The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. Social Group: The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader.
Falls Efficacy Scale - International (FES) PWD
28.09 score on a scale
Standard Deviation 11.42
27.23 score on a scale
Standard Deviation 10.38
21.73 score on a scale
Standard Deviation 5.32
25.36 score on a scale
Standard Deviation 5.27

SECONDARY outcome

Timeframe: Baseline

The NPI is a reliable and valid structured interview designed to assess neuropsychiatric symptoms in person with dementia through a structured interview with the caregiver. The NPI includes questions about 12 domains of symptoms: delusions, hallucinations, agitation/aggression, depression, anxiety, elation/ euphoria, apathy, disinhibition, irritability, aberrant motor activity, sleep, and eating. For each, symptom severity is scored on a scale of 0-4, with 4 being the worst outcome and caregiver distress is scored on a scale from 0-5, with 5 being the worst outcome. The sum of all 12 domains is calculated. Severity scores are reported here with a range from 0-36 with a higher score reflecting greater symptom severity.

Outcome measures

Outcome measures
Measure
No Contact
n=25 Participants
A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks No Contact: The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like.
Dance Group
n=24 Participants
The Dance Group will participate in 1-hour group improvisational dance lessons 2x/week for 12 weeks. Improvisational dance classes are grounded in 4 principles that shape the tone of the class and result in a sense of social belonging: non-judgment, non-competitiveness, curiosity, and playfulness. The following training strategies are used to maintain: active imagination, variability, and pacing. Dance Group: Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem.
Non-group Dance
n=25 Participants
The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week. Non-Group Dance: The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise.
Social Group
n=27 Participants
The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. Social Group: The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader.
Neuropsychiatric Inventory Questionnaire (NPI-Q)
7.72 score on a scale
Standard Deviation 6.13
6.83 score on a scale
Standard Deviation 5.64
5.44 score on a scale
Standard Deviation 4.44
6.85 score on a scale
Standard Deviation 4.86

SECONDARY outcome

Timeframe: Week 12

Population: Number at baseline and follow-up differ due to withdrawals and due to staff error during data collection.

The NPI is a reliable and valid structured interview designed to assess neuropsychiatric symptoms in person with dementia through a structured interview with the caregiver. The NPI includes questions about 12 domains of symptoms: delusions, hallucinations, agitation/aggression, depression, anxiety, elation/ euphoria, apathy, disinhibition, irritability, aberrant motor activity, sleep, and eating. For each, symptom severity is scored on a scale of 0-4, with 4 being the worst outcome and caregiver distress is scored on a scale from 0-5, with 5 being the worst outcome. The sum of all 12 domains is calculated. Severity scores are reported here with a range from 0-36 with a higher score reflecting greater symptom severity.

Outcome measures

Outcome measures
Measure
No Contact
n=23 Participants
A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks No Contact: The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like.
Dance Group
n=21 Participants
The Dance Group will participate in 1-hour group improvisational dance lessons 2x/week for 12 weeks. Improvisational dance classes are grounded in 4 principles that shape the tone of the class and result in a sense of social belonging: non-judgment, non-competitiveness, curiosity, and playfulness. The following training strategies are used to maintain: active imagination, variability, and pacing. Dance Group: Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem.
Non-group Dance
n=22 Participants
The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week. Non-Group Dance: The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise.
Social Group
n=22 Participants
The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. Social Group: The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader.
NPI-Q
8.39 score on a scale
Standard Deviation 5.25
6.38 score on a scale
Standard Deviation 5.48
5.22 score on a scale
Standard Deviation 4.66
5.63 score on a scale
Standard Deviation 5.71

SECONDARY outcome

Timeframe: Baseline

Population: Results at baseline for this outcome represent all PWD who were randomized.

The person with dementia will be asked to complete a screening tool for assessing depression. This test has 15 yes/no questions with a yes receiving 1 point for a depressive answer. A total score is calculated and will be on a scale from 0-15 with 0-4 indicating no depression, 5-10 suggestive of a mild depression, and 11+ suggestive of severe depression.

Outcome measures

Outcome measures
Measure
No Contact
n=25 Participants
A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks No Contact: The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like.
Dance Group
n=24 Participants
The Dance Group will participate in 1-hour group improvisational dance lessons 2x/week for 12 weeks. Improvisational dance classes are grounded in 4 principles that shape the tone of the class and result in a sense of social belonging: non-judgment, non-competitiveness, curiosity, and playfulness. The following training strategies are used to maintain: active imagination, variability, and pacing. Dance Group: Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem.
Non-group Dance
n=25 Participants
The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week. Non-Group Dance: The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise.
Social Group
n=27 Participants
The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. Social Group: The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader.
Geriatric Depression Scale
2.04 score on a scale
Standard Deviation 2.28
2.17 score on a scale
Standard Deviation 2.50
1.24 score on a scale
Standard Deviation 1.05
2.37 score on a scale
Standard Deviation 2.13

SECONDARY outcome

Timeframe: Week 12

Population: Overall number of participants analyzed corresponds to the number of participants who completed the study.

The person with dementia will be asked to complete a screening tool for assessing depression. This test has 15 yes/no questions with a yes receiving 1 point for a depressive answer. A total score is calculated and will be on a scale from 0-15 with 0-4 indicating no depression, 5-10 suggestive of a mild depression, and 11+ suggestive of severe depression.

Outcome measures

Outcome measures
Measure
No Contact
n=23 Participants
A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks No Contact: The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like.
Dance Group
n=22 Participants
The Dance Group will participate in 1-hour group improvisational dance lessons 2x/week for 12 weeks. Improvisational dance classes are grounded in 4 principles that shape the tone of the class and result in a sense of social belonging: non-judgment, non-competitiveness, curiosity, and playfulness. The following training strategies are used to maintain: active imagination, variability, and pacing. Dance Group: Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem.
Non-group Dance
n=22 Participants
The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week. Non-Group Dance: The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise.
Social Group
n=22 Participants
The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. Social Group: The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader.
Geriatric Depression Scale
2.74 score on a scale
Standard Deviation 3.54
2.27 score on a scale
Standard Deviation 2.76
1.32 score on a scale
Standard Deviation 1.36
1.68 score on a scale
Standard Deviation 1.29

SECONDARY outcome

Timeframe: Baseline

Population: Results at baseline for this outcome represent all PWD who were randomized.

The Geriatric Anxiety Scale measures symptoms of anxiety in older adults. A single total score ranges from 0 (low anxiety) to 63 (high anxiety). Four cutoff scores have been provided by authors in the manuals: 0-7 (normal anxiety), 8-15 (mild-moderate anxiety), 16-25 (moderate-severe anxiety), and 26-63 (severe anxiety).

Outcome measures

Outcome measures
Measure
No Contact
n=25 Participants
A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks No Contact: The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like.
Dance Group
n=24 Participants
The Dance Group will participate in 1-hour group improvisational dance lessons 2x/week for 12 weeks. Improvisational dance classes are grounded in 4 principles that shape the tone of the class and result in a sense of social belonging: non-judgment, non-competitiveness, curiosity, and playfulness. The following training strategies are used to maintain: active imagination, variability, and pacing. Dance Group: Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem.
Non-group Dance
n=25 Participants
The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week. Non-Group Dance: The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise.
Social Group
n=27 Participants
The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. Social Group: The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader.
Geriatric Anxiety Scale
3.56 score on a scale
Standard Deviation 3.31
3.71 score on a scale
Standard Deviation 3.34
2.92 score on a scale
Standard Deviation 2.06
4.04 score on a scale
Standard Deviation 3.01

SECONDARY outcome

Timeframe: Week 12

Population: Overall number of participants analyzed corresponds to the number of participants who completed the study.

The Geriatric Anxiety Scale measures symptoms of anxiety in older adults. A single total score ranges from 0 (low anxiety) to 63 (high anxiety). Four cutoff scores have been provided by authors in the manuals: 0-7 (normal anxiety), 8-15 (mild-moderate anxiety), 16-25 (moderate-severe anxiety), and 26-63 (severe anxiety).

Outcome measures

Outcome measures
Measure
No Contact
n=23 Participants
A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks No Contact: The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like.
Dance Group
n=22 Participants
The Dance Group will participate in 1-hour group improvisational dance lessons 2x/week for 12 weeks. Improvisational dance classes are grounded in 4 principles that shape the tone of the class and result in a sense of social belonging: non-judgment, non-competitiveness, curiosity, and playfulness. The following training strategies are used to maintain: active imagination, variability, and pacing. Dance Group: Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem.
Non-group Dance
n=22 Participants
The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week. Non-Group Dance: The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise.
Social Group
n=22 Participants
The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. Social Group: The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader.
Geriatric Anxiety Scale
4.0 score on a scale
Standard Deviation 4.65
3.64 score on a scale
Standard Deviation 3.63
2.23 score on a scale
Standard Deviation 1.57
3.64 score on a scale
Standard Deviation 3.27

SECONDARY outcome

Timeframe: Baseline

Population: Results at baseline for this outcome represent all PWD who were randomized.

The Apathy Evaluation Scale (AES) addresses characteristics of goal directed behavior that reflect apathy including behavioral, cognitive, and emotional indicators. A short form will be used that has been modified for use with people with dementia. This shortened version has 10 questions scored 1-4 with 4 being the positive outcome answer. The total score is calculated and on a scale of 10-40 with lower scores reflecting less apathy and thus a better outcome.

Outcome measures

Outcome measures
Measure
No Contact
n=25 Participants
A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks No Contact: The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like.
Dance Group
n=24 Participants
The Dance Group will participate in 1-hour group improvisational dance lessons 2x/week for 12 weeks. Improvisational dance classes are grounded in 4 principles that shape the tone of the class and result in a sense of social belonging: non-judgment, non-competitiveness, curiosity, and playfulness. The following training strategies are used to maintain: active imagination, variability, and pacing. Dance Group: Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem.
Non-group Dance
n=25 Participants
The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week. Non-Group Dance: The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise.
Social Group
n=27 Participants
The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. Social Group: The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader.
Apathy Evaluation Scale--PWD
18.44 score on a scale
Standard Deviation 7.53
21.83 score on a scale
Standard Deviation 8.49
18.88 score on a scale
Standard Deviation 6.23
19.74 score on a scale
Standard Deviation 7.04

SECONDARY outcome

Timeframe: Week 12

Population: One participant is missing follow-up data due to a recording error during data collection.

The Apathy Evaluation Scale (AES) addresses characteristics of goal directed behavior that reflect apathy including behavioral, cognitive, and emotional indicators. A short form will be used that has been modified for use with people with dementia. This shortened version has 10 questions scored 1-4 with 4 being the positive outcome answer. The total score is calculated and on a scale of 10-40 with lower scores reflecting less apathy and thus a better outcome.

Outcome measures

Outcome measures
Measure
No Contact
n=22 Participants
A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks No Contact: The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like.
Dance Group
n=22 Participants
The Dance Group will participate in 1-hour group improvisational dance lessons 2x/week for 12 weeks. Improvisational dance classes are grounded in 4 principles that shape the tone of the class and result in a sense of social belonging: non-judgment, non-competitiveness, curiosity, and playfulness. The following training strategies are used to maintain: active imagination, variability, and pacing. Dance Group: Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem.
Non-group Dance
n=22 Participants
The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week. Non-Group Dance: The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise.
Social Group
n=22 Participants
The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. Social Group: The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader.
Apathy Evaluation Scale--PWD
22.87 score on a scale
Standard Deviation 7.50
19.32 score on a scale
Standard Deviation 9.89
19.0 score on a scale
Standard Deviation 6.61
18.68 score on a scale
Standard Deviation 6.24

SECONDARY outcome

Timeframe: Baseline

The eSPPB is a brief test of global mobility function with excellent test-retest and inter-examiner reliability; is sensitive to change; is safe, and is a robust predictor of future physical disability and death. To avoid ceiling effects, investigators will use an expanded version (eSPPB) that increases the difficulty of the standing balance task by asking participants to hold postures for 30 instead of 10 seconds, adds a one-leg stand, and adds a narrow walk. The resulting score is normally distributed, continuous, and shows greater sensitivity to change. Dementia patients have lower scores on the SPPB so a favorable outcome for this outcome measure would be a significantly higher score post treatment. The eSPPB is scored as a continuous measure with a minimum score of 0 and a maximum score of 3.0 where 3 is the best possible outcome.

Outcome measures

Outcome measures
Measure
No Contact
n=25 Participants
A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks No Contact: The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like.
Dance Group
n=24 Participants
The Dance Group will participate in 1-hour group improvisational dance lessons 2x/week for 12 weeks. Improvisational dance classes are grounded in 4 principles that shape the tone of the class and result in a sense of social belonging: non-judgment, non-competitiveness, curiosity, and playfulness. The following training strategies are used to maintain: active imagination, variability, and pacing. Dance Group: Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem.
Non-group Dance
n=25 Participants
The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week. Non-Group Dance: The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise.
Social Group
n=27 Participants
The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. Social Group: The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader.
Expanded Short Physical Performance Battery (eSPPB)
1.86 score on a scale
Standard Deviation .40
1.57 score on a scale
Standard Deviation .55
1.99 score on a scale
Standard Deviation .37
1.67 score on a scale
Standard Deviation .46

SECONDARY outcome

Timeframe: Week 12

Population: Number at baseline and follow-up differ due to withdrawals, staff error, participant unwilling to complete, and participant unable to complete test.

The eSPPB is a brief test of global mobility function with excellent test-retest and inter-examiner reliability; is sensitive to change; is safe, and is a robust predictor of future physical disability and death. To avoid ceiling effects, investigators will use an expanded version (eSPPB) that increases the difficulty of the standing balance task by asking participants to hold postures for 30 instead of 10 seconds, adds a one-leg stand, and adds a narrow walk. The resulting score is normally distributed, continuous, and shows greater sensitivity to change. Dementia patients have lower scores on the SPPB so a favorable outcome for this outcome measure would be a significantly higher score post treatment. The eSPPB is scored as a continuous measure with a minimum score of 0 and a maximum score of 3.0 where 3 is the best possible outcome.

Outcome measures

Outcome measures
Measure
No Contact
n=21 Participants
A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks No Contact: The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like.
Dance Group
n=22 Participants
The Dance Group will participate in 1-hour group improvisational dance lessons 2x/week for 12 weeks. Improvisational dance classes are grounded in 4 principles that shape the tone of the class and result in a sense of social belonging: non-judgment, non-competitiveness, curiosity, and playfulness. The following training strategies are used to maintain: active imagination, variability, and pacing. Dance Group: Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem.
Non-group Dance
n=22 Participants
The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week. Non-Group Dance: The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise.
Social Group
n=21 Participants
The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. Social Group: The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader.
Expanded Short Physical Performance Battery (eSPPB)
1.88 score on a scale
Standard Deviation .50
1.62 score on a scale
Standard Deviation .57
1.98 score on a scale
Standard Deviation .39
1.66 score on a scale
Standard Deviation .44

SECONDARY outcome

Timeframe: Baseline

Population: Number of participants analyzed at baseline differs due to technical error.

Center of pressure displacement (area of the 95% confidence ellipse) using an AccuSway forceplate. Center of pressure displacement is one way to characterize postural sway. Increased postural sway is correlated with decreased balance in older adults and increased fall risk. Center of pressure displacement was measured using the area of the 95% confidence ellipse using an AccuSway forceplate. Higher numbers indicate greater levels of postural sway.

Outcome measures

Outcome measures
Measure
No Contact
n=25 Participants
A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks No Contact: The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like.
Dance Group
n=22 Participants
The Dance Group will participate in 1-hour group improvisational dance lessons 2x/week for 12 weeks. Improvisational dance classes are grounded in 4 principles that shape the tone of the class and result in a sense of social belonging: non-judgment, non-competitiveness, curiosity, and playfulness. The following training strategies are used to maintain: active imagination, variability, and pacing. Dance Group: Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem.
Non-group Dance
n=25 Participants
The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week. Non-Group Dance: The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise.
Social Group
n=26 Participants
The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. Social Group: The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader.
Postural Sway--PWD
0.49 centimeter squared
Standard Deviation 0.44
0.42 centimeter squared
Standard Deviation 0.37
0.37 centimeter squared
Standard Deviation 0.14
0.36 centimeter squared
Standard Deviation 0.21

SECONDARY outcome

Timeframe: Week 12

Population: Numbers averaged at baseline and follow-up differ due to withdrawals, technical errors, safety concern, participant unwilling and participant unable to continue.

Center of pressure displacement (area of the 95% confidence ellipse) using an AccuSway forceplate. Center of pressure displacement is one way to characterize postural sway. Increased postural sway is correlated with decreased balance in older adults and increased fall risk. Center of pressure displacement was measured using the area of the 95% confidence ellipse using an AccuSway forceplate. Higher numbers indicate greater levels of postural sway.

Outcome measures

Outcome measures
Measure
No Contact
n=21 Participants
A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks No Contact: The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like.
Dance Group
n=21 Participants
The Dance Group will participate in 1-hour group improvisational dance lessons 2x/week for 12 weeks. Improvisational dance classes are grounded in 4 principles that shape the tone of the class and result in a sense of social belonging: non-judgment, non-competitiveness, curiosity, and playfulness. The following training strategies are used to maintain: active imagination, variability, and pacing. Dance Group: Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem.
Non-group Dance
n=20 Participants
The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week. Non-Group Dance: The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise.
Social Group
n=22 Participants
The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. Social Group: The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader.
Postural Sway--PWD
0.52 centimeter squared
Standard Deviation 0.42
0.41 centimeter squared
Standard Deviation 0.22
0.38 centimeter squared
Standard Deviation 0.20
0.41 centimeter squared
Standard Deviation 0.26

SECONDARY outcome

Timeframe: Baseline

The time one takes to walk a specified distance on level surfaces over a short distance. 4m usual gait speed was measured as part of the eSPPB.

Outcome measures

Outcome measures
Measure
No Contact
n=25 Participants
A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks No Contact: The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like.
Dance Group
n=24 Participants
The Dance Group will participate in 1-hour group improvisational dance lessons 2x/week for 12 weeks. Improvisational dance classes are grounded in 4 principles that shape the tone of the class and result in a sense of social belonging: non-judgment, non-competitiveness, curiosity, and playfulness. The following training strategies are used to maintain: active imagination, variability, and pacing. Dance Group: Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem.
Non-group Dance
n=25 Participants
The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week. Non-Group Dance: The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise.
Social Group
n=27 Participants
The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. Social Group: The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader.
Gait Speed--PWD
4.66 seconds
Standard Deviation .85
5.47 seconds
Standard Deviation 1.55
4.61 seconds
Standard Deviation 1.03
5.12 seconds
Standard Deviation 1.39

SECONDARY outcome

Timeframe: Week 12

Population: Number at baseline and follow-up differ due to withdrawals, staff error, participant unwilling to complete and participant unable to complete.

The time one takes to walk a specified distance on level surfaces over a short distance. 4m usual gait speed was measured as part of the eSPPB.

Outcome measures

Outcome measures
Measure
No Contact
n=21 Participants
A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks No Contact: The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like.
Dance Group
n=22 Participants
The Dance Group will participate in 1-hour group improvisational dance lessons 2x/week for 12 weeks. Improvisational dance classes are grounded in 4 principles that shape the tone of the class and result in a sense of social belonging: non-judgment, non-competitiveness, curiosity, and playfulness. The following training strategies are used to maintain: active imagination, variability, and pacing. Dance Group: Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem.
Non-group Dance
n=22 Participants
The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week. Non-Group Dance: The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise.
Social Group
n=21 Participants
The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. Social Group: The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader.
Gait Speed--PWD
4.77 seconds
Standard Deviation 1.14
5.51 seconds
Standard Deviation 1.71
4.79 seconds
Standard Deviation .94
5.12 seconds
Standard Deviation 1.06

SECONDARY outcome

Timeframe: Baseline

Population: Subject numbers differ due to equipment failure, subjects withdrawing, subject inability to complete task, or lost to follow up.

Stride time variability, which is calculated out of the mean and standard deviation of stride time, reflects the change in time elapsed between the first two contacts of two consecutive footfalls of the same foot over a number of gait cycles. Increased gait variability is associated with increased fall risk in older adults.

Outcome measures

Outcome measures
Measure
No Contact
n=23 Participants
A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks No Contact: The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like.
Dance Group
n=21 Participants
The Dance Group will participate in 1-hour group improvisational dance lessons 2x/week for 12 weeks. Improvisational dance classes are grounded in 4 principles that shape the tone of the class and result in a sense of social belonging: non-judgment, non-competitiveness, curiosity, and playfulness. The following training strategies are used to maintain: active imagination, variability, and pacing. Dance Group: Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem.
Non-group Dance
n=22 Participants
The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week. Non-Group Dance: The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise.
Social Group
n=23 Participants
The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. Social Group: The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader.
Gait Variability--PWD
3.15 percentage of variability
Standard Deviation 1.07
3.41 percentage of variability
Standard Deviation 1.57
3.10 percentage of variability
Standard Deviation 1.68
3.44 percentage of variability
Standard Deviation 1.27

SECONDARY outcome

Timeframe: Week 12

Population: Subject numbers differ due to equipment failure, technical error, subjects withdrawing, subject inability to complete task, or subject unwilling to complete task.

Stride time variability, which is calculated out of the mean and standard deviation of stride time, reflects the change in time elapsed between the first two contacts of two consecutive footfalls of the same foot over a number of gait cycles. Increased gait variability is associated with increased fall risk in older adults.

Outcome measures

Outcome measures
Measure
No Contact
n=22 Participants
A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks No Contact: The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like.
Dance Group
n=21 Participants
The Dance Group will participate in 1-hour group improvisational dance lessons 2x/week for 12 weeks. Improvisational dance classes are grounded in 4 principles that shape the tone of the class and result in a sense of social belonging: non-judgment, non-competitiveness, curiosity, and playfulness. The following training strategies are used to maintain: active imagination, variability, and pacing. Dance Group: Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem.
Non-group Dance
n=21 Participants
The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week. Non-Group Dance: The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise.
Social Group
n=20 Participants
The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. Social Group: The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader.
Gait Variability--PWD
4.06 percentage of variability
Standard Deviation 4.15
4.46 percentage of variability
Standard Deviation 2.88
2.71 percentage of variability
Standard Deviation .75
3.45 percentage of variability
Standard Deviation 1.30

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Week 12

a measure of body fat based on height and weight that applies to adult men and women--PWD only

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Week12

PWD only

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

A measure of five domains of personality (neuroticism, extraversion, openness, agreeableness, and conscientiousness). A higher score on any scale indicates stronger presence of that trait. PWD only

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Week 12

The volume of white matter lesions is calculated using the Lesion Segmentation Toolbox. PWD only.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Week 12

Social engagement may change biomarkers of stress relevant for interpreting outcomes. These stress biomarkers include cortisol and allostatic load, a composite measure of blood-based biomarkers associated with chronically elevated stress. PWD only

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Week 12

The SF-36 consists of 36 questions assessing physical functioning, role functioning difficulties caused by physical problems, bodily pain, general health, vitality, social functioning, role functioning difficulties caused by emotional problems, and mental health. High scores are representative of a great health status and better outcomes, while low scores are representative of a poor health status.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Week 12

The Zarit Caregiver Burden Scale is administered in interview form to the caregiver. It consists of 22 questions scored 0-4 with 0=Never, 1=Rarely, 2=Sometimes, 3=Quite Frequently, 4=Nearly Always. The total score range is 0-88 with 88 being the worst possible outcome. 0-20 represents little or no burden on the caregiver, 21-40 represents mild to moderate burden, 41-60 represents moderate to severe burden, and 61-88 represents severe burden.

Outcome measures

Outcome data not reported

Adverse Events

Dance Group--PWD

Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths

Dance Group--Caregivers

Serious events: 4 serious events
Other events: 13 other events
Deaths: 0 deaths

Non-group Dance--PWD

Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths

Non-group Dance--Caregivers

Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths

Social Group--PWD

Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths

Social Group--Caregivers

Serious events: 4 serious events
Other events: 8 other events
Deaths: 0 deaths

No Contact--PWD

Serious events: 4 serious events
Other events: 17 other events
Deaths: 0 deaths

No Contact--Caregivers

Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths

Never Randomized-- PWD

Serious events: 3 serious events
Other events: 0 other events
Deaths: 1 deaths

Never Randomized--Caregiver

Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Dance Group--PWD
n=24 participants at risk
The Dance Group will participate in 1-hour group improvisational dance lessons 2x/week for 12 weeks. Improvisational dance classes are grounded in 4 principles that shape the tone of the class and result in a sense of social belonging: non-judgment, non-competitiveness, curiosity, and playfulness. The following training strategies are used to maintain: active imagination, variability, and pacing. Dance Group: Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem.
Dance Group--Caregivers
n=24 participants at risk
Caregivers of the PWDs in the Dance Group--these participants are part of the dyad mentioned in the participant flow.
Non-group Dance--PWD
n=25 participants at risk
The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week. Non-Group Dance: The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise.
Non-group Dance--Caregivers
n=25 participants at risk
Caregivers of the Non-group Dance PWDs--these participants are part of the dyad mentioned in the participant flow.
Social Group--PWD
n=27 participants at risk
The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. Social Group: The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader.
Social Group--Caregivers
n=27 participants at risk
Caregivers of the Social Group PWDs--these participants are part of the dyad mentioned in the participant flow.
No Contact--PWD
n=25 participants at risk
A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks No Contact: The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like.
No Contact--Caregivers
n=25 participants at risk
Caregivers of the No Contact PWDs--these participants are part of the dyad mentioned in the participant flow.
Never Randomized-- PWD
n=3 participants at risk
PWD who dropped out before randomization
Never Randomized--Caregiver
n=3 participants at risk
Caregivers of the PWDs who never randomized.
Cardiac disorders
Heart attack
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
3.7%
1/27 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
Reproductive system and breast disorders
Prostate cancer recurrence
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
4.0%
1/25 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
Musculoskeletal and connective tissue disorders
Elective full knee replacement
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
4.2%
1/24 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
Cardiac disorders
Acute congestive heart failure
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
3.7%
1/27 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
Vascular disorders
Elevated blood pressure
4.2%
1/24 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
4.0%
1/25 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
33.3%
1/3 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
Respiratory, thoracic and mediastinal disorders
Emergency room visit for shortness of breath
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
4.2%
1/24 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
Gastrointestinal disorders
Acute colitis
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
4.2%
1/24 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
4.0%
1/25 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
Psychiatric disorders
Admitted to hospital for suicidal ideation
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
4.0%
1/25 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
Respiratory, thoracic and mediastinal disorders
New diagnosis of non-small cell lung cancer
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
3.7%
1/27 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
Infections and infestations
Pain in hip due to sepsis
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
4.0%
1/25 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
Gastrointestinal disorders
Emergency room visit due to difficulty swallowing
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
4.0%
1/25 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
Injury, poisoning and procedural complications
Fell walking across street and hit chest on sidewalk
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
4.0%
1/25 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
Respiratory, thoracic and mediastinal disorders
Emergency room visit for chest discomfort
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
3.7%
1/27 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
Injury, poisoning and procedural complications
Accidentally given dilaudid in hospital
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
3.7%
1/27 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
Respiratory, thoracic and mediastinal disorders
Respiratory failure due to COVID
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
4.2%
1/24 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
Musculoskeletal and connective tissue disorders
Hit head falling backward getting out of bed
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
4.0%
1/25 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
Gastrointestinal disorders
Upper gastrointestinal bleed
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
3.7%
1/27 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
Nervous system disorders
Numbness and lack of coordination in arm
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
33.3%
1/3 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
Injury, poisoning and procedural complications
Complications and infection from hernia surgery
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
33.3%
1/3 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
General disorders
Death (prior to randomization)
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
33.3%
1/3 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.

Other adverse events

Other adverse events
Measure
Dance Group--PWD
n=24 participants at risk
The Dance Group will participate in 1-hour group improvisational dance lessons 2x/week for 12 weeks. Improvisational dance classes are grounded in 4 principles that shape the tone of the class and result in a sense of social belonging: non-judgment, non-competitiveness, curiosity, and playfulness. The following training strategies are used to maintain: active imagination, variability, and pacing. Dance Group: Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem.
Dance Group--Caregivers
n=24 participants at risk
Caregivers of the PWDs in the Dance Group--these participants are part of the dyad mentioned in the participant flow.
Non-group Dance--PWD
n=25 participants at risk
The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week. Non-Group Dance: The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise.
Non-group Dance--Caregivers
n=25 participants at risk
Caregivers of the Non-group Dance PWDs--these participants are part of the dyad mentioned in the participant flow.
Social Group--PWD
n=27 participants at risk
The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. Social Group: The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader.
Social Group--Caregivers
n=27 participants at risk
Caregivers of the Social Group PWDs--these participants are part of the dyad mentioned in the participant flow.
No Contact--PWD
n=25 participants at risk
A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks No Contact: The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like.
No Contact--Caregivers
n=25 participants at risk
Caregivers of the No Contact PWDs--these participants are part of the dyad mentioned in the participant flow.
Never Randomized-- PWD
n=3 participants at risk
PWD who dropped out before randomization
Never Randomized--Caregiver
n=3 participants at risk
Caregivers of the PWDs who never randomized.
Musculoskeletal and connective tissue disorders
Sprained foot after fall (unrelated to study)
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
4.0%
1/25 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
Musculoskeletal and connective tissue disorders
Shoulder pain from arthritis
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
4.2%
1/24 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
4.0%
1/25 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
Nervous system disorders
Shingles
4.2%
1/24 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
Musculoskeletal and connective tissue disorders
Fall outside of study, no treatment needed
20.8%
5/24 • Number of events 6 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
4.2%
1/24 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
20.0%
5/25 • Number of events 6 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
14.8%
4/27 • Number of events 5 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
14.8%
4/27 • Number of events 5 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
20.0%
5/25 • Number of events 5 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
20.0%
5/25 • Number of events 5 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
Musculoskeletal and connective tissue disorders
Fall during data collection visit, no treatment needed
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
4.2%
1/24 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
4.0%
1/25 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
Musculoskeletal and connective tissue disorders
Stumbled at home
4.2%
1/24 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
4.0%
1/25 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
3.7%
1/27 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
Musculoskeletal and connective tissue disorders
Leg pain
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
4.0%
1/25 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
Musculoskeletal and connective tissue disorders
Pulled muscle in lower back
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
4.2%
1/24 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
Gastrointestinal disorders
Chest pain due to gastrointestinal issue
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
4.2%
1/24 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
Product Issues
Discontinued atorvastatin
4.2%
1/24 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
Musculoskeletal and connective tissue disorders
Knee pain
4.2%
1/24 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
4.2%
1/24 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
8.0%
2/25 • Number of events 2 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
4.0%
1/25 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
Musculoskeletal and connective tissue disorders
Knee and hip pain
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
4.0%
1/25 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
Musculoskeletal and connective tissue disorders
Back pain
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
4.2%
1/24 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
3.7%
1/27 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
3.7%
1/27 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
4.0%
1/25 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
4.0%
1/25 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
Musculoskeletal and connective tissue disorders
Foot pain
8.3%
2/24 • Number of events 2 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
Renal and urinary disorders
Urinary tract infection
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
4.0%
1/25 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
4.0%
1/25 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
Musculoskeletal and connective tissue disorders
Toothache, swollen jaw
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
4.0%
1/25 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
Infections and infestations
Cellulitis
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
4.2%
1/24 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
4.0%
1/25 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
Musculoskeletal and connective tissue disorders
Hip pain during intervention
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
4.0%
1/25 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
Blood and lymphatic system disorders
Low hemoglobin
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
4.0%
1/25 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
Product Issues
Side effects from donepezil
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
3.7%
1/27 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
Injury, poisoning and procedural complications
Motor vehicle accident
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
4.0%
1/25 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
8.0%
2/25 • Number of events 2 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
Cardiac disorders
Chest pain and dizziness
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
4.0%
1/25 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
Injury, poisoning and procedural complications
Slipped on wet pavement
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
4.0%
1/25 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
Musculoskeletal and connective tissue disorders
Leg cramps
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
4.0%
1/25 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
General disorders
Exhaustion spell
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
4.0%
1/25 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
Musculoskeletal and connective tissue disorders
Broken ankle
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
4.0%
1/25 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
Respiratory, thoracic and mediastinal disorders
Respiratory infection
4.2%
1/24 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
4.0%
1/25 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
Respiratory, thoracic and mediastinal disorders
Recurrent pneumonia
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
4.0%
1/25 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
Musculoskeletal and connective tissue disorders
Knee arthroscopy
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
4.0%
1/25 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
Gastrointestinal disorders
Diverticulitis flare
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
4.0%
1/25 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
Infections and infestations
Acute cystitis
4.2%
1/24 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
Surgical and medical procedures
Aspiration of thyroid nodule
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
4.2%
1/24 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
Eye disorders
Eye surgery
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
4.0%
1/25 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
General disorders
Headache
4.2%
1/24 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
Blood and lymphatic system disorders
Abnormal lab results
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
8.3%
2/24 • Number of events 3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
4.0%
1/25 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
General disorders
Incidental finding on MRI-space occupying lesion
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
3.7%
1/27 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
General disorders
Seen by surgeon for hernia surgery-no treatment
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
Gastrointestinal disorders
Acute gastritis
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
4.2%
1/24 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
Musculoskeletal and connective tissue disorders
Ruptured patellar tendon
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
4.2%
1/24 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
Respiratory, thoracic and mediastinal disorders
Labored breathing and chest pain when bending over
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
4.0%
1/25 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
Musculoskeletal and connective tissue disorders
Tooth implants
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
3.7%
1/27 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
Gastrointestinal disorders
Diarrhea and cough
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
4.0%
1/25 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
Renal and urinary disorders
Laser cytoscopy for bladder stones
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
3.7%
1/27 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
Skin and subcutaneous tissue disorders
Basal cell carcinoma removed from arm
4.2%
1/24 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
General disorders
Admitted to rehabilitation center
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
3.7%
1/27 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
Musculoskeletal and connective tissue disorders
Bilateral recurrent inguinal hernia repair
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
3.7%
1/27 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
Infections and infestations
Sinus infection
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
4.0%
1/25 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
Infections and infestations
Infection in finger
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
3.7%
1/27 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
Ear and labyrinth disorders
Swimmer's ear
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
3.7%
1/27 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
Surgical and medical procedures
Injections for knee pain
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
4.0%
1/25 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
Surgical and medical procedures
Dermatology treatment
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
4.0%
1/25 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
Surgical and medical procedures
Removal of squamous cell carcinoma
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/24 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/27 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
4.0%
1/25 • Number of events 1 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/25 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
0.00%
0/3 • Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.

Additional Information

Christina Hugenschmidt, PhD

Wake Forest University School of Medicine

Phone: 336-713-8116

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place