Trial Outcomes & Findings for Exercise in Asymptomatic Pre-Alzheimer's Disease Pilot Study (NCT NCT01834716)
NCT ID: NCT01834716
Last Updated: 2019-03-29
Results Overview
The number of subjects retained at 6 month end of study time point.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
16 participants
Primary outcome timeframe
6 months
Results posted on
2019-03-29
Participant Flow
Participants were recruited via study invitations mailed to persons by age and zip code. Local community presentations were also conducted to recruit subjects.
Participant milestones
| Measure |
Non-Aerobics Exercise
Participants in this group will be randomized to a non-aerobics(attending classes of toning and stretching a minimum of three times per week) exercise group.
|
Aerobics Exercise
Participants in this group will be randomized to an aerobics exercise group (the equivalent of walking briskly for 50 minutes three times per week).
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
12
|
|
Overall Study
COMPLETED
|
4
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Exercise in Asymptomatic Pre-Alzheimer's Disease Pilot Study
Baseline characteristics by cohort
| Measure |
Non-aerobics Exercise
n=4 Participants
Participants in this group will be randomized to a non-aerobics exercise group (attending classes of toning and stretching a minimum of three times per week).
|
Aerobics Exercise
n=12 Participants
Participants in this group will be randomized to an aerobics exercise group (the equivalent of walking briskly for 50 minutes three times per week).
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
12 participants
n=7 Participants
|
16 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsThe number of subjects retained at 6 month end of study time point.
Outcome measures
| Measure |
Aerobics Exercise
n=11 Participants
Participants in this group will be randomized to aerobics exercise.
Aerobic vs. Non-Aerobic exercise
12 enrolled 11 completed
|
Non-Aerobics Exercise
n=4 Participants
Participants in this group will be randomized to a non-aerobics exercise group.
Aerobic vs. Non-Aerobic exercise
4 enrolled and 4 completed
|
|---|---|---|
|
Number of Subjects Retained at 6 Months
|
11 Participants
|
4 Participants
|
Adverse Events
Aerobics Exercise
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-Aerobics Exercise
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Aerobics Exercise
n=12 participants at risk
Participants in this group will be randomized to aerobics exercise (the equivalent of walking briskly for 50 minutes three times per week).
|
Non-Aerobics Exercise
n=4 participants at risk
Participants in this group will be randomized to a non-aerobics exercise group (attending classes of toning and stretching a minimum of three times per week).
|
|---|---|---|
|
General disorders
Cancer
|
8.3%
1/12 • Number of events 1 • Adverse events were collected at baseline, 3 months, and 6 months.
|
0.00%
0/4 • Adverse events were collected at baseline, 3 months, and 6 months.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place