Alzheimer’s Prevention Through Exercise

Overview

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.

Full Title of Study: “Effect of Aerobic Exercise on Pathophysiology of PreClinical Alzheimer’s Disease”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: December 31, 2019

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Aerobic Exercise Group
    • Exercise 150 minutes per week (over 3 to 5 days) for 52 weeks
  • Other: Control Group
    • Standard of Care exercise recommendations

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Whole Brain Volume
    • Time Frame: Baseline to 52 weeks
    • Whole brain volume in mL define by Freesurfer analysis. Higher numbers indicate greater brain volume. There is no defined maximum. Zero is the theoretical minimum.
  • Executive Function
    • Time Frame: Baseline to Week 52
    • Executive Function ability to be measured using confirmatory factor analysis (CFA). CFA aggregates scores from across multiple subtests. Values are standard deviations centered on a pooled baseline (all participant scores at baseline). Higher values mean improvement over baseline testing. Lower scores (including negative) mean worse performance after baseline testing. There is no minimum or maximum score.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 65 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Kansas Medical Center
  • Collaborator
    • National Institute on Aging (NIA)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jeffrey Burns, MD, Principal Investigator, University of Kansas Medical Center

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