Alzheimer's Prevention Through Exercise

Alzheimer's Disease Clinical Trial

— APEx  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02000583
• Other study ID #: 13376
• Secondary ID: R01AG043962-01
• Status: Completed
• Phase: N/A
• Start date: November 2013
• Est. completion date: December 31, 2019

Study information

• Verified date: July 2020
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

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

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amyloid Burden	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.	Baseline to 52 weeks
Secondary	Whole Brain Volume	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.	Baseline to 52 weeks
Secondary	Executive Function	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.	Baseline to Week 52