Exercise in Asymptomatic Pre-Alzheimer's Disease Pilot Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Exercise in Asymptomatic Pre-Alzheimer's Disease Pilot Study/ 18F-AV-45-A14 - CLINICAL EVALUATION OF FLORBETAPIR F 18 (18F-AV-45) Sponsor of 18F-AV-45-A14: Avid Radiopharmaceuticals

Conditions
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Alzheimer's Disease Prevention

Intervention / Treatment
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* Behavioral: Aerobic vs. Non-Aerobic exercise


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aerobics exercise<br>Participants in this group will be randomized to aerobics exercise (the equivalent of walking briskly for 50 minutes three times per week). | Behavioral: Aerobic vs. Non-Aerobic exercise<br> <br> |
| Experimental: Non-Aerobics Exercise<br>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. | Behavioral: Aerobic vs. Non-Aerobic exercise<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects Retained at 6 Months | The number of subjects retained at 6 month end of study time point. | 6 months |