Effect of Aerobic Exercise on Pathophysiology of PreClinical Alzheimer's Disease

University of Kansas Medical Center1 site in 1 country117 target enrollmentNovember 2013

ConditionsAlzheimer's Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Alzheimer's Disease
Sponsor: University of Kansas Medical Center
Enrollment: 117
Locations: 1
Primary Endpoint: Amyloid Burden
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

November 2013

End Date

December 31, 2019

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Kansas Medical Center

Responsible Party

Sponsor

Eligibility Criteria

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

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.