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Alzheimer's Prevention Through Exercise (APEx)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02000583
Recruitment Status : Completed
First Posted : December 4, 2013
Results First Posted : July 28, 2020
Last Update Posted : July 28, 2020
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
University of Kansas Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Other: Aerobic Exercise Other: Standard of Care Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 117 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Aerobic Exercise on Pathophysiology of PreClinical Alzheimer's Disease
Study Start Date : November 2013
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Aerobic Exercise Group
Exercise 150 minutes per week (over 3 to 5 days) for 52 weeks
 Other: Aerobic Exercise
Aerobic group participants will engage in 150 minutes of aerobic exercise over 4-5 days per week for 52 weeks
Control Group
Standard of Care exercise recommendations
 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.
Other Name: Standard of Care for exercise recommendations


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02000583


Locations
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United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas Medical Center
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Jeffrey Burns, MD University of Kansas Medical Center
  Study Documents (Full-Text)

Documents provided by University of Kansas Medical Center:
Informed Consent Form  [PDF] June 5, 2018
Study Protocol and Statistical Analysis Plan  [PDF] April 22, 2016

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT02000583    
Other Study ID Numbers: 13376
R01AG043962-01 ( U.S. NIH Grant/Contract )
First Posted: December 4, 2013    Key Record Dates
Results First Posted: July 28, 2020
Last Update Posted: July 28, 2020
Last Verified: July 2020
Keywords provided by University of Kansas Medical Center:
Alzheimer's Disease
AD
Aerobic Exercise
Exercise
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders