Alzheimer's Disease Prevention
Conditions
Brief summary
Researchers are trying to determine if cognitively normal subjects undergoing a moderate aerobic exercise program will accumulate less amyloid-ß (Aβ) concentration in their brain than subjects undergoing a non-aerobic exercise program, and further evaluating the safety and imaging characteristics of florbetapir F 18, the radioactive drug that will allow us to image changes in the brain amyloid-ß (Aβ).
Detailed description
After screening assessments have been completed, subjects will be randomized into one of two groups: aerobic exercise group and non-aerobic exercise group. All subjects will be trained on the Physical Activity Scale for the Elderly (PASE), using the Body Media armband, and exercise diary. Subjects will also complete an online food questionnaire. Subjects assigned to the aerobic exercise group will work with an exercise trainer who will provide individual training (six half hour sessions) until they are proficient at the use of the equipment and understand goals. Subjects will return to Brooks Family YMCA at their convenience, but at a minimum of four times per week. Subjects will complete the exercise journal daily and the Physical Activity Scale for the Elderly (PASE) questionnaire on a monthly basis. Subjects assigned to the non-aerobic exercise group will attend supervised classes on toning and stretching at a minimum of four times per week. Subjects will complete the exercise journal daily and the Physical Activity Scale for the Elderly (PASE) questionnaire on a monthly basis.
Interventions
BEHAVIORALAerobic vs. Non-Aerobic exercise
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 65 years of age or older. * Not diagnosed with memory problems. * Do not exercise in which you sweat and/or raise your pulse rate more than 30 minutes two times per week. * Able to walk ten blocks (about one mile). * Willing to participate in weekly exercise classes at the Brooks YMCA for six months. * Able to have an MRI and CT/PET scan.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Retained at 6 Months | 6 months | The number of subjects retained at 6 month end of study time point. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited via study invitations mailed to persons by age and zip code. Local community presentations were also conducted to recruit subjects.
Participants by arm
| Arm | Count |
|---|---|
| Non-aerobics Exercise 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). | 4 |
| 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). | 12 |
| Total | 16 |
Baseline characteristics
| Characteristic | Non-aerobics Exercise | Aerobics Exercise | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 12 Participants | 16 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 4 participants | 12 participants | 16 participants |
| Sex: Female, Male Female | 3 Participants | 4 Participants | 7 Participants |
| Sex: Female, Male Male | 1 Participants | 8 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 4 |
| other Total, other adverse events | 0 / 12 | 0 / 4 |
| serious Total, serious adverse events | 1 / 12 | 0 / 4 |
Outcome results
Primary
Number of Subjects Retained at 6 Months
The number of subjects retained at 6 month end of study time point.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Aerobics Exercise | Number of Subjects Retained at 6 Months | 11 Participants |
| Non-Aerobics Exercise | Number of Subjects Retained at 6 Months | 4 Participants |