Alzheimer's Prevention Through Exercise

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

117 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2019-12-31

Brief Summary

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The purpose of this study is to learn about the possible benefits of aerobic exercise in controlling or reducing the amount of amyloid present in the brain, reducing changes in brain structure that may lead to Alzheimer's Disease (AD), and increasing cognitive ability in individuals that have amyloid deposits and are at risk to develop AD.

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Detailed Description

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Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Aerobic Exercise Group

Exercise 150 minutes per week (over 3 to 5 days) for 52 weeks

Group Type EXPERIMENTAL

Aerobic Exercise

Intervention Type OTHER

Aerobic group participants will engage in 150 minutes of aerobic exercise over 4-5 days per week for 52 weeks

Control Group

Standard of Care exercise recommendations

Group Type OTHER

Standard of Care

Intervention Type OTHER

Control group participants will be provided educational materials on starting an exercise program, but will receive no formal support for their exercise program.

Interventions

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Aerobic Exercise

Aerobic group participants will engage in 150 minutes of aerobic exercise over 4-5 days per week for 52 weeks

Intervention Type OTHER

Standard of Care

Control group participants will be provided educational materials on starting an exercise program, but will receive no formal support for their exercise program.

Intervention Type OTHER

Other Intervention Names

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Standard of Care for exercise recommendations

Eligibility Criteria

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Inclusion Criteria

* Clinical Dementia Rating 0 (nondemented)
* Age 65 or older
* Florbetapir PET evidence of cerebral amyloidosis
* Sedentary or underactive by the Telephone Assessment of Physical Activity
* Stable doses of medications for 30 days.
* Clinician judgment regarding subject's health status and likelihood to successfully complete the 1-year exercise intervention

Exclusion Criteria

* Clinically significant major psychiatric disorder (e.g., Major Depressive Disorder) according to standard criteria or significant psychiatric symptoms that could impair the completion of the study
* Clinically-significant systemic illness that may affect safety or completion of the study
* History of clinically-evident stroke
* Clinically-significant infection within the last 30 days
* Active cardiac condition (e.g. angina, myocardial infarction, atrial fibrillation) or pulmonary condition in the past 2 years that, in the investigator's opinion, could pose a safety risk to the participant-unless cleared for exercise by the participant's primary care physician or cardiologist.
* Uncontrolled hypertension within the last 6 months
* History of cancer in the last 5 years (except non-metastatic basal or squamous cell carcinoma)
* History of drug or alcohol abuse as defined by DSM-IV criteria within the last 2 years
* Insulin-dependent diabetes mellitus
* Significant pain or musculoskeletal disorder prohibiting participation in an exercise program
* Unwillingness to undergo or contraindication to brain MRI scan.
* History within the last 5 years of primary or recurrent malignant disease with the exception of resected localized cutaneous squamous cell carcinoma, basal cell carcinoma, cervical carcinoma, or prostate cancer.

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No