Trial Outcomes & Findings for Cognitive Training and Neuroplasticity in Mild Cognitive Impairment (NCT NCT03205709)
NCT ID: NCT03205709
Last Updated: 2024-09-19
Results Overview
The modified ADAS-Cog is a cognitive battery that assesses learning, memory, language production, language comprehension, constructional praxis, ideational praxis, and orientation. Value range: 0-70. A higher score indicates worse cognition.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
107 participants
Primary outcome timeframe
[Time Frame: 78 weeks]
Results posted on
2024-09-19
Participant Flow
Participant milestones
| Measure |
Training Group 1
Computerized Cognitive Training
Computerized Cognitive Training: Computerized online cognitive training will be used to target specific cognitive abilities and neural networks to potentially improve cognitive functioning through neuroplasticity.
|
Training Group 2
Crossword puzzles
Crossword Puzzles: These are intended to mimic crossword puzzles in newspapers.
|
|---|---|---|
|
Overall Study
STARTED
|
51
|
56
|
|
Overall Study
COMPLETED
|
44
|
49
|
|
Overall Study
NOT COMPLETED
|
7
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cognitive Training and Neuroplasticity in Mild Cognitive Impairment
Baseline characteristics by cohort
| Measure |
Training Group 1
n=51 Participants
Computerized Cognitive Training
Computerized Cognitive Training: Computerized online cognitive training will be used to target specific cognitive abilities and neural networks to potentially improve cognitive functioning through neuroplasticity.
|
Training Group 2
n=56 Participants
Crossword Puzzles
Crossword Puzzles: These are intended to mimic crossword puzzles in newspapers.
|
Total
n=107 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age ≤70 yr with early MCI
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Age, Customized
Age ≤70 yr with late MCI
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Age, Customized
Age >70 yr with early MCI
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Age, Customized
Age >70 yr with late MCI
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
50 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
39 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
81 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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
MMSE total score
|
27.1 score
STANDARD_DEVIATION 1.6 • n=5 Participants
|
26.8 score
STANDARD_DEVIATION 1.7 • n=7 Participants
|
26.97 score
STANDARD_DEVIATION 1.6 • n=5 Participants
|
|
ADAS-Cog total score
|
9.5 score
STANDARD_DEVIATION 3.5 • n=5 Participants
|
9.6 score
STANDARD_DEVIATION 3.5 • n=7 Participants
|
9.6 score
STANDARD_DEVIATION 3.5 • n=5 Participants
|
|
Neuropsychological composite z-score
|
-0.1 units on a scale
STANDARD_DEVIATION 1.0 • n=5 Participants
|
0.1 units on a scale
STANDARD_DEVIATION 1.0 • n=7 Participants
|
0 units on a scale
STANDARD_DEVIATION 1.0 • n=5 Participants
|
|
UPSA total score
|
80.6 score
STANDARD_DEVIATION 10.9 • n=5 Participants
|
81.5 score
STANDARD_DEVIATION 11.4 • n=7 Participants
|
81.1 score
STANDARD_DEVIATION 11.1 • n=5 Participants
|
|
FAQ total score
|
3.4 score
STANDARD_DEVIATION 4.1 • n=5 Participants
|
3.2 score
STANDARD_DEVIATION 3.9 • n=7 Participants
|
3.26 score
STANDARD_DEVIATION 4.0 • n=5 Participants
|
PRIMARY outcome
Timeframe: [Time Frame: 78 weeks]Population: Participants assessed at baseline and week 78, and the change over 78 weeks is the outcome.
The modified ADAS-Cog is a cognitive battery that assesses learning, memory, language production, language comprehension, constructional praxis, ideational praxis, and orientation. Value range: 0-70. A higher score indicates worse cognition.
Outcome measures
| Measure |
Training Group 1
n=44 Participants
Computerized Cognitive Training
Computerized Cognitive Training: Computerized online cognitive training will be used to target specific cognitive abilities and neural networks to potentially improve cognitive functioning through neuroplasticity.
|
Training Group 2
n=51 Participants
Crossword puzzles
Crossword Puzzles: These are intended to mimic crossword puzzles in newspapers.
|
|---|---|---|
|
Change in the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog)
|
-0.89 score
Standard Error 0.51
|
0.55 score
Standard Error 0.48
|
SECONDARY outcome
Timeframe: [Time Frame: Week 78]Population: Participants assessed at baseline and week 78, and the change over 78 weeks is the outcome.
Neuropsychological Testing Composite Score is a compiled score of all neuropsychological tests administered in the protocol, i.e. Auditory Verbal Learning Test, Block Design, Verbal Fluency, Visual Reproduction, Boston Naming Task, Trails A and B. The composite neuropsychological test battery is derived by computing the baseline z-score for each individual test and then averaging the resulting z scores. The range will be -5 to +5. z score of 0 represents the sample mean and higher z score indicates better performance.
Outcome measures
| Measure |
Training Group 1
n=51 Participants
Computerized Cognitive Training
Computerized Cognitive Training: Computerized online cognitive training will be used to target specific cognitive abilities and neural networks to potentially improve cognitive functioning through neuroplasticity.
|
Training Group 2
n=56 Participants
Crossword puzzles
Crossword Puzzles: These are intended to mimic crossword puzzles in newspapers.
|
|---|---|---|
|
Change Over Time in Neuropsychological Testing Composite Score
|
-0.24 score
Standard Error 0.08
|
-0.27 score
Standard Error 0.07
|
SECONDARY outcome
Timeframe: [Time Frame: week 78]Population: Participants assessed at baseline and week 78, and the change over 78 weeks is the outcome.
FAQ: Functional Activities Questionnaire (FAQ) measures instrumental activities of daily living (IADLs), such as preparing balanced meals and managing personal finances. The score ranges from 0-30. A higher score indicates a greater level of impairment in the instrumental activities of daily living.
Outcome measures
| Measure |
Training Group 1
n=51 Participants
Computerized Cognitive Training
Computerized Cognitive Training: Computerized online cognitive training will be used to target specific cognitive abilities and neural networks to potentially improve cognitive functioning through neuroplasticity.
|
Training Group 2
n=56 Participants
Crossword puzzles
Crossword Puzzles: These are intended to mimic crossword puzzles in newspapers.
|
|---|---|---|
|
Change Over Time in Functional Activities Questionnaire (FAQ)
|
-2.00 score
Standard Error 0.34
|
-0.92 score
Standard Error 0.31
|
SECONDARY outcome
Timeframe: [Time Frame: week 78]Population: Participants assessed at baseline and week 78, and the change over 78 weeks is the outcome.
UPSA: UCSD Performance-Based Skills Assessment. The UPSA is a performance-based measure of functional abilities that includes measures of simulated real-world activities, for example, planning a trip to the beach, remembering documents to bring to a medical appointment, and dialing a phone number. A higher score indicates greater cognitive function. For the UPSA the z score at baseline is computed (based on the mean and SD of the raw scores). The expected range is -5 to +5 with z score of 0 representing the sample mean and higher z score indicating better performance.
Outcome measures
| Measure |
Training Group 1
n=51 Participants
Computerized Cognitive Training
Computerized Cognitive Training: Computerized online cognitive training will be used to target specific cognitive abilities and neural networks to potentially improve cognitive functioning through neuroplasticity.
|
Training Group 2
n=56 Participants
Crossword puzzles
Crossword Puzzles: These are intended to mimic crossword puzzles in newspapers.
|
|---|---|---|
|
Change Over Time in UCSD Performance-Based Skills Assessment (UPSA)
|
0.55 score
Standard Error 1.23
|
-0.99 score
Standard Error 1.44
|
Adverse Events
Training Group 1
Serious events: 12 serious events
Other events: 19 other events
Deaths: 0 deaths
Training Group 2
Serious events: 9 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Training Group 1
n=51 participants at risk
Computerized Cognitive Training
Computerized Cognitive Training: Computerized online cognitive training will be used to target specific cognitive abilities and neural networks to potentially improve cognitive functioning through neuroplasticity.
|
Training Group 2
n=56 participants at risk
Crossword puzzles
Crossword Puzzles: These are intended to mimic crossword puzzles in newspapers.
|
|---|---|---|
|
Psychiatric disorders
Psychiatric disorders
|
0.00%
0/51 • Adverse event data was collected for each participant throughout the study participant duration of 78 weeks.
The definitions used to collect adverse event information in this study align with those from the clinicaltrials.gov definitions. Adverse events were reported to research staff and study physicians. These adverse events were recorded, reported per the IRB guidelines, and assessed by the study DSMB.
|
1.8%
1/56 • Number of events 1 • Adverse event data was collected for each participant throughout the study participant duration of 78 weeks.
The definitions used to collect adverse event information in this study align with those from the clinicaltrials.gov definitions. Adverse events were reported to research staff and study physicians. These adverse events were recorded, reported per the IRB guidelines, and assessed by the study DSMB.
|
|
General disorders
Falls
|
3.9%
2/51 • Number of events 2 • Adverse event data was collected for each participant throughout the study participant duration of 78 weeks.
The definitions used to collect adverse event information in this study align with those from the clinicaltrials.gov definitions. Adverse events were reported to research staff and study physicians. These adverse events were recorded, reported per the IRB guidelines, and assessed by the study DSMB.
|
1.8%
1/56 • Number of events 1 • Adverse event data was collected for each participant throughout the study participant duration of 78 weeks.
The definitions used to collect adverse event information in this study align with those from the clinicaltrials.gov definitions. Adverse events were reported to research staff and study physicians. These adverse events were recorded, reported per the IRB guidelines, and assessed by the study DSMB.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
2.0%
1/51 • Number of events 1 • Adverse event data was collected for each participant throughout the study participant duration of 78 weeks.
The definitions used to collect adverse event information in this study align with those from the clinicaltrials.gov definitions. Adverse events were reported to research staff and study physicians. These adverse events were recorded, reported per the IRB guidelines, and assessed by the study DSMB.
|
0.00%
0/56 • Adverse event data was collected for each participant throughout the study participant duration of 78 weeks.
The definitions used to collect adverse event information in this study align with those from the clinicaltrials.gov definitions. Adverse events were reported to research staff and study physicians. These adverse events were recorded, reported per the IRB guidelines, and assessed by the study DSMB.
|
|
Cardiac disorders
Cardiac disorders
|
0.00%
0/51 • Adverse event data was collected for each participant throughout the study participant duration of 78 weeks.
The definitions used to collect adverse event information in this study align with those from the clinicaltrials.gov definitions. Adverse events were reported to research staff and study physicians. These adverse events were recorded, reported per the IRB guidelines, and assessed by the study DSMB.
|
3.6%
2/56 • Number of events 2 • Adverse event data was collected for each participant throughout the study participant duration of 78 weeks.
The definitions used to collect adverse event information in this study align with those from the clinicaltrials.gov definitions. Adverse events were reported to research staff and study physicians. These adverse events were recorded, reported per the IRB guidelines, and assessed by the study DSMB.
|
|
Vascular disorders
Vascular disorders
|
5.9%
3/51 • Number of events 3 • Adverse event data was collected for each participant throughout the study participant duration of 78 weeks.
The definitions used to collect adverse event information in this study align with those from the clinicaltrials.gov definitions. Adverse events were reported to research staff and study physicians. These adverse events were recorded, reported per the IRB guidelines, and assessed by the study DSMB.
|
1.8%
1/56 • Number of events 1 • Adverse event data was collected for each participant throughout the study participant duration of 78 weeks.
The definitions used to collect adverse event information in this study align with those from the clinicaltrials.gov definitions. Adverse events were reported to research staff and study physicians. These adverse events were recorded, reported per the IRB guidelines, and assessed by the study DSMB.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder
|
3.9%
2/51 • Number of events 2 • Adverse event data was collected for each participant throughout the study participant duration of 78 weeks.
The definitions used to collect adverse event information in this study align with those from the clinicaltrials.gov definitions. Adverse events were reported to research staff and study physicians. These adverse events were recorded, reported per the IRB guidelines, and assessed by the study DSMB.
|
0.00%
0/56 • Adverse event data was collected for each participant throughout the study participant duration of 78 weeks.
The definitions used to collect adverse event information in this study align with those from the clinicaltrials.gov definitions. Adverse events were reported to research staff and study physicians. These adverse events were recorded, reported per the IRB guidelines, and assessed by the study DSMB.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders
|
2.0%
1/51 • Number of events 1 • Adverse event data was collected for each participant throughout the study participant duration of 78 weeks.
The definitions used to collect adverse event information in this study align with those from the clinicaltrials.gov definitions. Adverse events were reported to research staff and study physicians. These adverse events were recorded, reported per the IRB guidelines, and assessed by the study DSMB.
|
0.00%
0/56 • Adverse event data was collected for each participant throughout the study participant duration of 78 weeks.
The definitions used to collect adverse event information in this study align with those from the clinicaltrials.gov definitions. Adverse events were reported to research staff and study physicians. These adverse events were recorded, reported per the IRB guidelines, and assessed by the study DSMB.
|
|
Renal and urinary disorders
Urinary disorder
|
0.00%
0/51 • Adverse event data was collected for each participant throughout the study participant duration of 78 weeks.
The definitions used to collect adverse event information in this study align with those from the clinicaltrials.gov definitions. Adverse events were reported to research staff and study physicians. These adverse events were recorded, reported per the IRB guidelines, and assessed by the study DSMB.
|
3.6%
2/56 • Number of events 2 • Adverse event data was collected for each participant throughout the study participant duration of 78 weeks.
The definitions used to collect adverse event information in this study align with those from the clinicaltrials.gov definitions. Adverse events were reported to research staff and study physicians. These adverse events were recorded, reported per the IRB guidelines, and assessed by the study DSMB.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorders
|
5.9%
3/51 • Number of events 3 • Adverse event data was collected for each participant throughout the study participant duration of 78 weeks.
The definitions used to collect adverse event information in this study align with those from the clinicaltrials.gov definitions. Adverse events were reported to research staff and study physicians. These adverse events were recorded, reported per the IRB guidelines, and assessed by the study DSMB.
|
1.8%
1/56 • Number of events 1 • Adverse event data was collected for each participant throughout the study participant duration of 78 weeks.
The definitions used to collect adverse event information in this study align with those from the clinicaltrials.gov definitions. Adverse events were reported to research staff and study physicians. These adverse events were recorded, reported per the IRB guidelines, and assessed by the study DSMB.
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
0.00%
0/51 • Adverse event data was collected for each participant throughout the study participant duration of 78 weeks.
The definitions used to collect adverse event information in this study align with those from the clinicaltrials.gov definitions. Adverse events were reported to research staff and study physicians. These adverse events were recorded, reported per the IRB guidelines, and assessed by the study DSMB.
|
1.8%
1/56 • Number of events 1 • Adverse event data was collected for each participant throughout the study participant duration of 78 weeks.
The definitions used to collect adverse event information in this study align with those from the clinicaltrials.gov definitions. Adverse events were reported to research staff and study physicians. These adverse events were recorded, reported per the IRB guidelines, and assessed by the study DSMB.
|
Other adverse events
| Measure |
Training Group 1
n=51 participants at risk
Computerized Cognitive Training
Computerized Cognitive Training: Computerized online cognitive training will be used to target specific cognitive abilities and neural networks to potentially improve cognitive functioning through neuroplasticity.
|
Training Group 2
n=56 participants at risk
Crossword puzzles
Crossword Puzzles: These are intended to mimic crossword puzzles in newspapers.
|
|---|---|---|
|
General disorders
Fatigue
|
3.9%
2/51 • Number of events 3 • Adverse event data was collected for each participant throughout the study participant duration of 78 weeks.
The definitions used to collect adverse event information in this study align with those from the clinicaltrials.gov definitions. Adverse events were reported to research staff and study physicians. These adverse events were recorded, reported per the IRB guidelines, and assessed by the study DSMB.
|
3.6%
2/56 • Number of events 2 • Adverse event data was collected for each participant throughout the study participant duration of 78 weeks.
The definitions used to collect adverse event information in this study align with those from the clinicaltrials.gov definitions. Adverse events were reported to research staff and study physicians. These adverse events were recorded, reported per the IRB guidelines, and assessed by the study DSMB.
|
|
General disorders
Falls
|
3.9%
2/51 • Number of events 4 • Adverse event data was collected for each participant throughout the study participant duration of 78 weeks.
The definitions used to collect adverse event information in this study align with those from the clinicaltrials.gov definitions. Adverse events were reported to research staff and study physicians. These adverse events were recorded, reported per the IRB guidelines, and assessed by the study DSMB.
|
1.8%
1/56 • Number of events 1 • Adverse event data was collected for each participant throughout the study participant duration of 78 weeks.
The definitions used to collect adverse event information in this study align with those from the clinicaltrials.gov definitions. Adverse events were reported to research staff and study physicians. These adverse events were recorded, reported per the IRB guidelines, and assessed by the study DSMB.
|
|
Eye disorders
Eye disorders
|
2.0%
1/51 • Number of events 1 • Adverse event data was collected for each participant throughout the study participant duration of 78 weeks.
The definitions used to collect adverse event information in this study align with those from the clinicaltrials.gov definitions. Adverse events were reported to research staff and study physicians. These adverse events were recorded, reported per the IRB guidelines, and assessed by the study DSMB.
|
7.1%
4/56 • Number of events 5 • Adverse event data was collected for each participant throughout the study participant duration of 78 weeks.
The definitions used to collect adverse event information in this study align with those from the clinicaltrials.gov definitions. Adverse events were reported to research staff and study physicians. These adverse events were recorded, reported per the IRB guidelines, and assessed by the study DSMB.
|
|
Ear and labyrinth disorders
Ear, nose, throat disorders
|
3.9%
2/51 • Number of events 3 • Adverse event data was collected for each participant throughout the study participant duration of 78 weeks.
The definitions used to collect adverse event information in this study align with those from the clinicaltrials.gov definitions. Adverse events were reported to research staff and study physicians. These adverse events were recorded, reported per the IRB guidelines, and assessed by the study DSMB.
|
3.6%
2/56 • Number of events 2 • Adverse event data was collected for each participant throughout the study participant duration of 78 weeks.
The definitions used to collect adverse event information in this study align with those from the clinicaltrials.gov definitions. Adverse events were reported to research staff and study physicians. These adverse events were recorded, reported per the IRB guidelines, and assessed by the study DSMB.
|
|
Skin and subcutaneous tissue disorders
Skin cancer
|
2.0%
1/51 • Number of events 1 • Adverse event data was collected for each participant throughout the study participant duration of 78 weeks.
The definitions used to collect adverse event information in this study align with those from the clinicaltrials.gov definitions. Adverse events were reported to research staff and study physicians. These adverse events were recorded, reported per the IRB guidelines, and assessed by the study DSMB.
|
3.6%
2/56 • Number of events 2 • Adverse event data was collected for each participant throughout the study participant duration of 78 weeks.
The definitions used to collect adverse event information in this study align with those from the clinicaltrials.gov definitions. Adverse events were reported to research staff and study physicians. These adverse events were recorded, reported per the IRB guidelines, and assessed by the study DSMB.
|
|
Immune system disorders
Hematological/immune disorders
|
2.0%
1/51 • Number of events 2 • Adverse event data was collected for each participant throughout the study participant duration of 78 weeks.
The definitions used to collect adverse event information in this study align with those from the clinicaltrials.gov definitions. Adverse events were reported to research staff and study physicians. These adverse events were recorded, reported per the IRB guidelines, and assessed by the study DSMB.
|
0.00%
0/56 • Adverse event data was collected for each participant throughout the study participant duration of 78 weeks.
The definitions used to collect adverse event information in this study align with those from the clinicaltrials.gov definitions. Adverse events were reported to research staff and study physicians. These adverse events were recorded, reported per the IRB guidelines, and assessed by the study DSMB.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
2.0%
1/51 • Number of events 2 • Adverse event data was collected for each participant throughout the study participant duration of 78 weeks.
The definitions used to collect adverse event information in this study align with those from the clinicaltrials.gov definitions. Adverse events were reported to research staff and study physicians. These adverse events were recorded, reported per the IRB guidelines, and assessed by the study DSMB.
|
1.8%
1/56 • Number of events 1 • Adverse event data was collected for each participant throughout the study participant duration of 78 weeks.
The definitions used to collect adverse event information in this study align with those from the clinicaltrials.gov definitions. Adverse events were reported to research staff and study physicians. These adverse events were recorded, reported per the IRB guidelines, and assessed by the study DSMB.
|
|
Cardiac disorders
Elective cardiac surgery
|
2.0%
1/51 • Number of events 1 • Adverse event data was collected for each participant throughout the study participant duration of 78 weeks.
The definitions used to collect adverse event information in this study align with those from the clinicaltrials.gov definitions. Adverse events were reported to research staff and study physicians. These adverse events were recorded, reported per the IRB guidelines, and assessed by the study DSMB.
|
3.6%
2/56 • Number of events 3 • Adverse event data was collected for each participant throughout the study participant duration of 78 weeks.
The definitions used to collect adverse event information in this study align with those from the clinicaltrials.gov definitions. Adverse events were reported to research staff and study physicians. These adverse events were recorded, reported per the IRB guidelines, and assessed by the study DSMB.
|
|
Renal and urinary disorders
Urinary tract disorders
|
0.00%
0/51 • Adverse event data was collected for each participant throughout the study participant duration of 78 weeks.
The definitions used to collect adverse event information in this study align with those from the clinicaltrials.gov definitions. Adverse events were reported to research staff and study physicians. These adverse events were recorded, reported per the IRB guidelines, and assessed by the study DSMB.
|
3.6%
2/56 • Number of events 4 • Adverse event data was collected for each participant throughout the study participant duration of 78 weeks.
The definitions used to collect adverse event information in this study align with those from the clinicaltrials.gov definitions. Adverse events were reported to research staff and study physicians. These adverse events were recorded, reported per the IRB guidelines, and assessed by the study DSMB.
|
|
Musculoskeletal and connective tissue disorders
Arthritis, musculoskeletal symptoms
|
3.9%
2/51 • Number of events 5 • Adverse event data was collected for each participant throughout the study participant duration of 78 weeks.
The definitions used to collect adverse event information in this study align with those from the clinicaltrials.gov definitions. Adverse events were reported to research staff and study physicians. These adverse events were recorded, reported per the IRB guidelines, and assessed by the study DSMB.
|
1.8%
1/56 • Number of events 2 • Adverse event data was collected for each participant throughout the study participant duration of 78 weeks.
The definitions used to collect adverse event information in this study align with those from the clinicaltrials.gov definitions. Adverse events were reported to research staff and study physicians. These adverse events were recorded, reported per the IRB guidelines, and assessed by the study DSMB.
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
2.0%
1/51 • Number of events 1 • Adverse event data was collected for each participant throughout the study participant duration of 78 weeks.
The definitions used to collect adverse event information in this study align with those from the clinicaltrials.gov definitions. Adverse events were reported to research staff and study physicians. These adverse events were recorded, reported per the IRB guidelines, and assessed by the study DSMB.
|
3.6%
2/56 • Number of events 2 • Adverse event data was collected for each participant throughout the study participant duration of 78 weeks.
The definitions used to collect adverse event information in this study align with those from the clinicaltrials.gov definitions. Adverse events were reported to research staff and study physicians. These adverse events were recorded, reported per the IRB guidelines, and assessed by the study DSMB.
|
|
General disorders
Headache
|
3.9%
2/51 • Number of events 3 • Adverse event data was collected for each participant throughout the study participant duration of 78 weeks.
The definitions used to collect adverse event information in this study align with those from the clinicaltrials.gov definitions. Adverse events were reported to research staff and study physicians. These adverse events were recorded, reported per the IRB guidelines, and assessed by the study DSMB.
|
3.6%
2/56 • Number of events 2 • Adverse event data was collected for each participant throughout the study participant duration of 78 weeks.
The definitions used to collect adverse event information in this study align with those from the clinicaltrials.gov definitions. Adverse events were reported to research staff and study physicians. These adverse events were recorded, reported per the IRB guidelines, and assessed by the study DSMB.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
2.0%
1/51 • Number of events 1 • Adverse event data was collected for each participant throughout the study participant duration of 78 weeks.
The definitions used to collect adverse event information in this study align with those from the clinicaltrials.gov definitions. Adverse events were reported to research staff and study physicians. These adverse events were recorded, reported per the IRB guidelines, and assessed by the study DSMB.
|
3.6%
2/56 • Number of events 4 • Adverse event data was collected for each participant throughout the study participant duration of 78 weeks.
The definitions used to collect adverse event information in this study align with those from the clinicaltrials.gov definitions. Adverse events were reported to research staff and study physicians. These adverse events were recorded, reported per the IRB guidelines, and assessed by the study DSMB.
|
|
Respiratory, thoracic and mediastinal disorders
COVID-19 diagnosis
|
3.9%
2/51 • Number of events 5 • Adverse event data was collected for each participant throughout the study participant duration of 78 weeks.
The definitions used to collect adverse event information in this study align with those from the clinicaltrials.gov definitions. Adverse events were reported to research staff and study physicians. These adverse events were recorded, reported per the IRB guidelines, and assessed by the study DSMB.
|
0.00%
0/56 • Adverse event data was collected for each participant throughout the study participant duration of 78 weeks.
The definitions used to collect adverse event information in this study align with those from the clinicaltrials.gov definitions. Adverse events were reported to research staff and study physicians. These adverse events were recorded, reported per the IRB guidelines, and assessed by the study DSMB.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place