Alzheimer's Prevention Through Exercise (APEx)

University of Kansas

Status: Completed

Conditions: Alzheimer's Disease

Treatments: Other: Standard of Care; Other: Aerobic Exercise

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02000583

R01AG043962-01 (U.S. NIH Grant/Contract)

13376

Details and patient eligibility

About

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.

Enrollment: 117 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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117 participants in 2 patient groups

Aerobic Exercise Group

Experimental group

Description:

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

Treatment:

Other: Aerobic Exercise

Control Group

Other group

Description:

Standard of Care exercise recommendations

Treatment:

Other: Standard of Care