Trial Outcomes & Findings for Prazosin for Agitation in Alzheimer's Disease (NCT NCT03710642)

Last Updated: 2023-02-06

Results Overview

The ADCS-CGIC-A is the primary outcome measure. It will be anchored to disruptive agitation, the target behaviors in this study. It measures whether the effects of active treatment are substantial enough to be detected by a skilled and experienced clinician on the basis of a direct examination of the participant and an interview of the participant's primary caregiver and other LTC facility staff. The baseline assessment is qualitative therefore there is no score at baseline; post-baseline scores represent a change score compared to baseline. The ADCS-CGIC-A is a 7-point scale that is structured as the clinician's assessment of change from baseline compared to the ADCS-CGIC-A Baseline Worksheet. There is no baseline score; post-baseline scores range from 1 (improvement) to 7 (worsening). A score of 1-2 indicates clinically meaningful improvement; a score of 3-5 indicates no clinically meaningful change; a score of 6-7 indicates clinically meaningful worsening.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

35 participants

Primary outcome timeframe

From Baseline through Week 12.

Results posted on

2023-02-06

Participant Flow

Recruitment initiated September 2018: The research was initially approved for enrollment at Long Term Care facilities. Covid-19 impacted these facilities, and protocol amendments were approved to allow home-dwelling participants with full-time caregivers to enroll into the trial. Recruitment came from a blend of LTC facilities and institution/clinics.

Of the 54 participants consented and screened, 35 were eligible to participate in the trial and 19 were screening failures. Of the 35 participants randomized, 34 participants went on to receive study drug. One patient discontinued after randomization but prior to first dose administration.

Participant milestones

Participant milestones
Measure	Treatment (Prazosin) Eligible participants will be randomized using a 2:1 schedule to prazosin or placebo and stratified by site and gender, and will follow a fixed titration scheme for the first 15 days, followed by a flexible does titration from days 15-29, then a maintenance phase stable dose from days 29 to the end of the 12 weeks study period. Prazosin Fixed titration dose schedule for Days 1 to 14 1 mg QHS for Days 1 to 3 1 mg QAM and 1 mg QHS for days 4 to 7 1. mg QAM and 2 mg QHS for days 8 to 10 2. mg QAM and 2 mg QHS for days 11 to 14 Prazosin Flexible titration dose schedule for Days 15 to 29. 3 mg QAM and 3 mg QHS on day 15, 4 mg QAM and 4 mg QHS on day 22, 4 mg QAH and 6 mg QHS on day 29, Dose increases will be allowed only during the fixed and flexible dosing periods. Prazosin: Oral prazosin HCl capsules (or placebo) will be administered twice daily, with individualized doses up to a maximum of 4 mg QAM mid-morning and 6 mg at bedtime (QHS), or matching placebo capsules	Placebo Oral Capsule Placebo medication will be administered in a titration schedule mimicking the active comparator treatment. Placebo oral capsule: Placebo capsule matched to appearance of active drug.
Overall Study STARTED	27	8
Overall Study COMPLETED	17	3
Overall Study NOT COMPLETED	10	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Prazosin) Eligible participants will be randomized using a 2:1 schedule to prazosin or placebo and stratified by site and gender, and will follow a fixed titration scheme for the first 15 days, followed by a flexible does titration from days 15-29, then a maintenance phase stable dose from days 29 to the end of the 12 weeks study period. Prazosin Fixed titration dose schedule for Days 1 to 14 1 mg QHS for Days 1 to 3 1 mg QAM and 1 mg QHS for days 4 to 7 1. mg QAM and 2 mg QHS for days 8 to 10 2. mg QAM and 2 mg QHS for days 11 to 14 Prazosin Flexible titration dose schedule for Days 15 to 29. 3 mg QAM and 3 mg QHS on day 15, 4 mg QAM and 4 mg QHS on day 22, 4 mg QAH and 6 mg QHS on day 29, Dose increases will be allowed only during the fixed and flexible dosing periods. Prazosin: Oral prazosin HCl capsules (or placebo) will be administered twice daily, with individualized doses up to a maximum of 4 mg QAM mid-morning and 6 mg at bedtime (QHS), or matching placebo capsules	Placebo Oral Capsule Placebo medication will be administered in a titration schedule mimicking the active comparator treatment. Placebo oral capsule: Placebo capsule matched to appearance of active drug.
Overall Study Adverse Event	5	1
Overall Study non-site physician recommendation	1	0
Overall Study Participant unwilling or unable to participate	1	1
Overall Study "other" is selected as the reason for study termination	1	3
Overall Study NA-no code provided	1	0
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Prazosin for Agitation in Alzheimer's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Prazosin) n=26 Participants Eligible participants will be randomized using a 2:1 schedule to prazosin or placebo and stratified by site and gender, and will follow a fixed titration scheme for the first 15 days, followed by a flexible does titration from days 15-29, then a maintenance phase stable dose from days 29 to the end of the 12 weeks study period. Prazosin Fixed titration dose schedule for Days 1 to 14 1 mg QHS for Days 1 to 3 1 mg QAM and 1 mg QHS for days 4 to 7 1. mg QAM and 2 mg QHS for days 8 to 10 2. mg QAM and 2 mg QHS for days 11 to 14 Prazosin Flexible titration dose schedule for Days 15 to 29. 3 mg QAM and 3 mg QHS on day 15, 4 mg QAM and 4 mg QHS on day 22, 4 mg QAH and 6 mg QHS on day 29, Dose increases will be allowed only during the fixed and flexible dosing periods. Prazosin: Oral prazosin HCl capsules (or placebo) will be administered twice daily, with individualized doses up to a maximum of 4 mg QAM mid-morning and 6 mg at bedtime (QHS), or matching placebo capsules	Placebo Oral Capsule n=8 Participants Placebo medication will be administered in a titration schedule mimicking the active comparator treatment. Placebo oral capsule: Placebo capsule matched to appearance of active drug.	Total n=34 Participants Total of all reporting groups
Age, Continuous	80.02 years STANDARD_DEVIATION 11.27 • n=5 Participants	78.53 years STANDARD_DEVIATION 8.0 • n=7 Participants	79.67 years STANDARD_DEVIATION 10.5 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	6 Participants n=7 Participants	25 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	2 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=5 Participants	8 Participants n=7 Participants	29 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	24 Participants n=5 Participants	8 Participants n=7 Participants	32 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	26 participants n=5 Participants	8 participants n=7 Participants	34 participants n=5 Participants

PRIMARY outcome

Timeframe: From Baseline through Week 12.

Population: The population analyzed for this outcome includes: 20 study completers, and 3 early terminations that completed their termination visit at or after the week 10 timepoint. Therefore, the N analyzed is higher than the numbers of completers listed in the participant flow section.

Outcome measures

Outcome measures
Measure	Treatment (Prazosin) n=19 Participants Eligible participants will be randomized using a 2:1 schedule to prazosin or placebo and stratified by site and gender, and will follow a fixed titration scheme for the first 15 days, followed by a flexible does titration from days 15-29, then a maintenance phase stable dose from days 29 to the end of the 12 weeks study period. Prazosin Fixed titration dose schedule for Days 1 to 14 1 mg QHS for Days 1 to 3 1 mg QAM and 1 mg QHS for days 4 to 7 1. mg QAM and 2 mg QHS for days 8 to 10 2. mg QAM and 2 mg QHS for days 11 to 14 Prazosin Flexible titration dose schedule for Days 15 to 29. 3 mg QAM and 3 mg QHS on day 15, 4 mg QAM and 4 mg QHS on day 22, 4 mg QAH and 6 mg QHS on day 29, Dose increases will be allowed only during the fixed and flexible dosing periods. Prazosin: Oral prazosin HCl capsules (or placebo) will be administered twice daily, with individualized doses up to a maximum of 4 mg QAM mid-morning and 6 mg at bedtime (QHS), or matching placebo capsules	Placebo Oral Capsule n=4 Participants Placebo medication will be administered in a titration schedule mimicking the active comparator treatment. Placebo oral capsule: Placebo capsule matched to appearance of active drug.
ADCS-Clinical Global Impression of Change in Agitation (ADCS-CGIC-A)	3.434 score on a scale Standard Error 0.2833	3.442 score on a scale Standard Error 0.6141

SECONDARY outcome

Timeframe: 12 weeks

The NPI was designed to characterize the neuropsychiatric symptoms and psychopathology of patients with AD and other dementias residing in the community about which information was obtained from family caregivers. The content of the questions and their scoring in the NPI-NH are identical to those of the NPI except for some slight rephrasing to be consistent with the LTC environment where information is gathered from professional caregivers. Assessment of the impact of behavioral disturbances on family and professional caregivers, is assessed by a caregiver distress scale in the NPI and an occupational disruptiveness scale in the NPI-NH; scoring of this component remains identical. Minimum score is 0 and highest score is 144. A higher score means a worse outcome. This outcome is the change from baseline to week 12.

Outcome measures

Outcome measures
Measure	Treatment (Prazosin) n=24 Participants Eligible participants will be randomized using a 2:1 schedule to prazosin or placebo and stratified by site and gender, and will follow a fixed titration scheme for the first 15 days, followed by a flexible does titration from days 15-29, then a maintenance phase stable dose from days 29 to the end of the 12 weeks study period. Prazosin Fixed titration dose schedule for Days 1 to 14 1 mg QHS for Days 1 to 3 1 mg QAM and 1 mg QHS for days 4 to 7 1. mg QAM and 2 mg QHS for days 8 to 10 2. mg QAM and 2 mg QHS for days 11 to 14 Prazosin Flexible titration dose schedule for Days 15 to 29. 3 mg QAM and 3 mg QHS on day 15, 4 mg QAM and 4 mg QHS on day 22, 4 mg QAH and 6 mg QHS on day 29, Dose increases will be allowed only during the fixed and flexible dosing periods. Prazosin: Oral prazosin HCl capsules (or placebo) will be administered twice daily, with individualized doses up to a maximum of 4 mg QAM mid-morning and 6 mg at bedtime (QHS), or matching placebo capsules	Placebo Oral Capsule n=7 Participants Placebo medication will be administered in a titration schedule mimicking the active comparator treatment. Placebo oral capsule: Placebo capsule matched to appearance of active drug.
Neuropsychiatric Inventory (NPI)/Neuropsychiatry Inventory-Nursing Home Version (NPI-NH)	-6.033 units on a scale Standard Error 4.692	5.506 units on a scale Standard Error 10.149

SECONDARY outcome

Timeframe: 12 weeks

Cumulative total dose of Lorazepam rescue medication administered during the trial. Information on the total mg rescue lorazepam administered will be collected as additional secondary outcome measures. If prazosin is more effective than placebo, it is predicted that participants randomized to prazosin will be prescribed lower cumulative mg of rescue lorazepam for management of persistent or worsening disruptive agitation.

Outcome measures

Outcome measures
Measure	Treatment (Prazosin) n=24 Participants Eligible participants will be randomized using a 2:1 schedule to prazosin or placebo and stratified by site and gender, and will follow a fixed titration scheme for the first 15 days, followed by a flexible does titration from days 15-29, then a maintenance phase stable dose from days 29 to the end of the 12 weeks study period. Prazosin Fixed titration dose schedule for Days 1 to 14 1 mg QHS for Days 1 to 3 1 mg QAM and 1 mg QHS for days 4 to 7 1. mg QAM and 2 mg QHS for days 8 to 10 2. mg QAM and 2 mg QHS for days 11 to 14 Prazosin Flexible titration dose schedule for Days 15 to 29. 3 mg QAM and 3 mg QHS on day 15, 4 mg QAM and 4 mg QHS on day 22, 4 mg QAH and 6 mg QHS on day 29, Dose increases will be allowed only during the fixed and flexible dosing periods. Prazosin: Oral prazosin HCl capsules (or placebo) will be administered twice daily, with individualized doses up to a maximum of 4 mg QAM mid-morning and 6 mg at bedtime (QHS), or matching placebo capsules	Placebo Oral Capsule n=7 Participants Placebo medication will be administered in a titration schedule mimicking the active comparator treatment. Placebo oral capsule: Placebo capsule matched to appearance of active drug.
Rescue Medication: Total mg Lorazepam Administered	0.25 mg Standard Deviation 0.69	0.14 mg Standard Deviation 0.24

SECONDARY outcome

Timeframe: 12 weeks

Cox proportional hazard modelling comparing the median time to drop out between treatment groups.

Outcome measures

Outcome measures
Measure	Treatment (Prazosin) n=27 Participants Eligible participants will be randomized using a 2:1 schedule to prazosin or placebo and stratified by site and gender, and will follow a fixed titration scheme for the first 15 days, followed by a flexible does titration from days 15-29, then a maintenance phase stable dose from days 29 to the end of the 12 weeks study period. Prazosin Fixed titration dose schedule for Days 1 to 14 1 mg QHS for Days 1 to 3 1 mg QAM and 1 mg QHS for days 4 to 7 1. mg QAM and 2 mg QHS for days 8 to 10 2. mg QAM and 2 mg QHS for days 11 to 14 Prazosin Flexible titration dose schedule for Days 15 to 29. 3 mg QAM and 3 mg QHS on day 15, 4 mg QAM and 4 mg QHS on day 22, 4 mg QAH and 6 mg QHS on day 29, Dose increases will be allowed only during the fixed and flexible dosing periods. Prazosin: Oral prazosin HCl capsules (or placebo) will be administered twice daily, with individualized doses up to a maximum of 4 mg QAM mid-morning and 6 mg at bedtime (QHS), or matching placebo capsules	Placebo Oral Capsule n=8 Participants Placebo medication will be administered in a titration schedule mimicking the active comparator treatment. Placebo oral capsule: Placebo capsule matched to appearance of active drug.
Study Discontinuations	65.63 days Standard Deviation 32.63	54.62 days Standard Deviation 33.29

SECONDARY outcome

Timeframe: 12 weeks

Comparison of proportions of responders versus non responders on the ADCS-CGIC-A. Responders are defined as those with moderate or marked improvement in agitation symptoms compared to baseline assessment.

Outcome measures

Outcome measures
Measure	Treatment (Prazosin) n=19 Participants Eligible participants will be randomized using a 2:1 schedule to prazosin or placebo and stratified by site and gender, and will follow a fixed titration scheme for the first 15 days, followed by a flexible does titration from days 15-29, then a maintenance phase stable dose from days 29 to the end of the 12 weeks study period. Prazosin Fixed titration dose schedule for Days 1 to 14 1 mg QHS for Days 1 to 3 1 mg QAM and 1 mg QHS for days 4 to 7 1. mg QAM and 2 mg QHS for days 8 to 10 2. mg QAM and 2 mg QHS for days 11 to 14 Prazosin Flexible titration dose schedule for Days 15 to 29. 3 mg QAM and 3 mg QHS on day 15, 4 mg QAM and 4 mg QHS on day 22, 4 mg QAH and 6 mg QHS on day 29, Dose increases will be allowed only during the fixed and flexible dosing periods. Prazosin: Oral prazosin HCl capsules (or placebo) will be administered twice daily, with individualized doses up to a maximum of 4 mg QAM mid-morning and 6 mg at bedtime (QHS), or matching placebo capsules	Placebo Oral Capsule n=4 Participants Placebo medication will be administered in a titration schedule mimicking the active comparator treatment. Placebo oral capsule: Placebo capsule matched to appearance of active drug.
Responder Analysis on CGIC-A	7 Participants	1 Participants

SECONDARY outcome

Timeframe: 12 weeks

The ADCS-ADL-Severe questionnaire is a secondary outcome measure aimed at detecting functional decline in people with severe AD. This scale is best suited for evaluating people with MMSE scores below 15/30, or equivalent. Questions are administered to a qualified caregiver informant about a set of 19 basic and instrumental ADL. Instrumental ADL are selected to be relevant to this level of severity of dementia, e.g., obtaining a beverage, turning lights on and off, turning a faucet on and off. Performance of each of these activities during the past 4 weeks, as well as the level of performance, are rated. A total score is derived by summing scores across items, and ranges from 0 (maximal impairment) to 54 (maximally independent function). This outcome is the change from baseline to week 12.

Outcome measures

Outcome measures
Measure	Treatment (Prazosin) n=19 Participants Eligible participants will be randomized using a 2:1 schedule to prazosin or placebo and stratified by site and gender, and will follow a fixed titration scheme for the first 15 days, followed by a flexible does titration from days 15-29, then a maintenance phase stable dose from days 29 to the end of the 12 weeks study period. Prazosin Fixed titration dose schedule for Days 1 to 14 1 mg QHS for Days 1 to 3 1 mg QAM and 1 mg QHS for days 4 to 7 1. mg QAM and 2 mg QHS for days 8 to 10 2. mg QAM and 2 mg QHS for days 11 to 14 Prazosin Flexible titration dose schedule for Days 15 to 29. 3 mg QAM and 3 mg QHS on day 15, 4 mg QAM and 4 mg QHS on day 22, 4 mg QAH and 6 mg QHS on day 29, Dose increases will be allowed only during the fixed and flexible dosing periods. Prazosin: Oral prazosin HCl capsules (or placebo) will be administered twice daily, with individualized doses up to a maximum of 4 mg QAM mid-morning and 6 mg at bedtime (QHS), or matching placebo capsules	Placebo Oral Capsule n=4 Participants Placebo medication will be administered in a titration schedule mimicking the active comparator treatment. Placebo oral capsule: Placebo capsule matched to appearance of active drug.
ADCS-ADL-Severe	-1.47055 score on a scale Standard Error 1.0062	-4.53993 score on a scale Standard Error 2.1863

SECONDARY outcome

Timeframe: 12 weeks

Comparison of effects on caregiver distress/occupational disruptiveness scores on the NPI/NPI-NH. Minimum score is 0 and maximum score is 60. A higher score is a worse outcome. This outcome is the change from baseline to week 12.

Outcome measures

Outcome measures
Measure	Treatment (Prazosin) n=19 Participants Eligible participants will be randomized using a 2:1 schedule to prazosin or placebo and stratified by site and gender, and will follow a fixed titration scheme for the first 15 days, followed by a flexible does titration from days 15-29, then a maintenance phase stable dose from days 29 to the end of the 12 weeks study period. Prazosin Fixed titration dose schedule for Days 1 to 14 1 mg QHS for Days 1 to 3 1 mg QAM and 1 mg QHS for days 4 to 7 1. mg QAM and 2 mg QHS for days 8 to 10 2. mg QAM and 2 mg QHS for days 11 to 14 Prazosin Flexible titration dose schedule for Days 15 to 29. 3 mg QAM and 3 mg QHS on day 15, 4 mg QAM and 4 mg QHS on day 22, 4 mg QAH and 6 mg QHS on day 29, Dose increases will be allowed only during the fixed and flexible dosing periods. Prazosin: Oral prazosin HCl capsules (or placebo) will be administered twice daily, with individualized doses up to a maximum of 4 mg QAM mid-morning and 6 mg at bedtime (QHS), or matching placebo capsules	Placebo Oral Capsule n=4 Participants Placebo medication will be administered in a titration schedule mimicking the active comparator treatment. Placebo oral capsule: Placebo capsule matched to appearance of active drug.
Caregiver Distress on NPI/NPI-NH	-2.4438 score on a scale Standard Error 2.332	0.9446 score on a scale Standard Error 5.043

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks

The CMAI is an exploratory outcome measure for estimating frequency of agitated behaviors. The CMAI assesses the frequency of agitated behaviors in elderly persons and was developed for use in the LTC facility. The CMAI rates 29 agitated behaviors, each on a 7-point scale (1-7) of frequency ranging from never to several times per hour. Ratings pertain to the 2-week period preceding the rating. A higher score means a worse outcome.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks

The Neuropsychiatric Inventory (NPI)/Neuropsychiatry Inventory-Nursing Home version (NPI-NH) subset score includes agitation/aggression, anxiety, disinhibition, irritability/lability and aberrant motor activity. Minimum and maximum values are 0 and 60 respectively. A higher score is a worse outcome.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks

Actigraphy measures of locomotor activity during the night will be compared between groups.

Outcome measures

Outcome data not reported

Adverse Events

Treatment (Prazosin)

Serious events: 5 serious events

Other events: 13 other events

Deaths: 0 deaths

Placebo Oral Capsule

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Prazosin) n=26 participants at risk Eligible participants will be randomized using a 2:1 schedule to prazosin or placebo and stratified by site and gender, and will follow a fixed titration scheme for the first 15 days, followed by a flexible does titration from days 15-29, then a maintenance phase stable dose from days 29 to the end of the 12 weeks study period. Prazosin Fixed titration dose schedule for Days 1 to 14 1 mg QHS for Days 1 to 3 1 mg QAM and 1 mg QHS for days 4 to 7 1. mg QAM and 2 mg QHS for days 8 to 10 2. mg QAM and 2 mg QHS for days 11 to 14 Prazosin Flexible titration dose schedule for Days 15 to 29. 3 mg QAM and 3 mg QHS on day 15, 4 mg QAM and 4 mg QHS on day 22, 4 mg QAH and 6 mg QHS on day 29, Dose increases will be allowed only during the fixed and flexible dosing periods. Prazosin: Oral prazosin HCl capsules (or placebo) will be administered twice daily, with individualized doses up to a maximum of 4 mg QAM mid-morning and 6 mg at bedtime (QHS), or matching placebo capsules	Placebo Oral Capsule n=8 participants at risk Placebo medication will be administered in a titration schedule mimicking the active comparator treatment. Placebo oral capsule: Placebo capsule matched to appearance of active drug.
Nervous system disorders Syncope	3.8% 1/26 • Adverse event data were collected from signed consent through the participant duration in the study. The specific time period is from consent through the end of the 12 week double-blind trial.	0.00% 0/8 • Adverse event data were collected from signed consent through the participant duration in the study. The specific time period is from consent through the end of the 12 week double-blind trial.
Cardiac disorders Syncope	3.8% 1/26 • Adverse event data were collected from signed consent through the participant duration in the study. The specific time period is from consent through the end of the 12 week double-blind trial.	0.00% 0/8 • Adverse event data were collected from signed consent through the participant duration in the study. The specific time period is from consent through the end of the 12 week double-blind trial.
Infections and infestations Pneumonia	3.8% 1/26 • Adverse event data were collected from signed consent through the participant duration in the study. The specific time period is from consent through the end of the 12 week double-blind trial.	0.00% 0/8 • Adverse event data were collected from signed consent through the participant duration in the study. The specific time period is from consent through the end of the 12 week double-blind trial.
Injury, poisoning and procedural complications Fall	3.8% 1/26 • Adverse event data were collected from signed consent through the participant duration in the study. The specific time period is from consent through the end of the 12 week double-blind trial.	0.00% 0/8 • Adverse event data were collected from signed consent through the participant duration in the study. The specific time period is from consent through the end of the 12 week double-blind trial.
Nervous system disorders Dementia Alzheimer's type	3.8% 1/26 • Adverse event data were collected from signed consent through the participant duration in the study. The specific time period is from consent through the end of the 12 week double-blind trial.	0.00% 0/8 • Adverse event data were collected from signed consent through the participant duration in the study. The specific time period is from consent through the end of the 12 week double-blind trial.
Vascular disorders Syncope	3.8% 1/26 • Adverse event data were collected from signed consent through the participant duration in the study. The specific time period is from consent through the end of the 12 week double-blind trial.	0.00% 0/8 • Adverse event data were collected from signed consent through the participant duration in the study. The specific time period is from consent through the end of the 12 week double-blind trial.
Injury, poisoning and procedural complications Upper limb fracture	3.8% 1/26 • Adverse event data were collected from signed consent through the participant duration in the study. The specific time period is from consent through the end of the 12 week double-blind trial.	0.00% 0/8 • Adverse event data were collected from signed consent through the participant duration in the study. The specific time period is from consent through the end of the 12 week double-blind trial.

Other adverse events

Additional Information

Clinical Operations

Alzheimer's Disease Cooperative Study (ADCS)

Phone: 858-246-1333

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place