NCT02000583CompletedNot Applicable
Effect of Aerobic Exercise on Pathophysiology of PreClinical Alzheimer's Disease
University of Kansas Medical Center1 site in 1 country117 target enrollmentStarted: November 1, 2013Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 117
- Locations
- 1
- Primary Endpoint
- Amyloid Burden
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Aerobic Exercise Group
Experimental
Exercise 150 minutes per week (over 3 to 5 days) for 52 weeks
Intervention: Aerobic Exercise (Other)
Control Group
Other
Standard of Care exercise recommendations
Intervention: Standard of Care (Other)
Outcomes
Primary Outcomes
Amyloid Burden
Time Frame: Baseline to 52 weeks
Amyloid burden measure is mean Florbetapir cortical-to-cerebellar uptake ratio averaged across 6 regions of interest (frontal, temporal, parietal, anterior cingulate, posterior cingulate, and precuneus). Higher numbers mean more amyloid accumulation. There is no defined maximum value. Zero is the theoretical minimum value.
Secondary Outcomes
- Executive Function(Baseline to Week 52)
- Whole Brain Volume(Baseline to 52 weeks)
Investigators
Study Sites (1)
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