Trial record 2 of 9 for:    Alzheimer's AND Jeffrey Burns

Alzheimer's Prevention Through Exercise (APEx)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of Kansas
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Kansas
ClinicalTrials.gov Identifier:
NCT02000583
First received: November 26, 2013
Last updated: June 26, 2014
Last verified: June 2014
  Purpose

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 Intervention
Alzheimer's Disease
Other: Aerobic Exercise
Other: Standard of Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Aerobic Exercise on Pathophysiology of PreClinical Alzheimer's Disease

Resource links provided by NLM:


Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • Change in amyloid burden [ Time Frame: Change from Baseline to 52 weeks ] [ Designated as safety issue: No ]
    amyloid burden measure will be mean change from baseline to 52 weeks in Florbetapir cortical-to-cerebellar ratio averaged across 6 regions of interest (frontal, temporal, parietal, anterior cingulate, posterior cingulate, and precuneus)


Secondary Outcome Measures:
  • Amount of reduction in structural brain changes in preclinical AD [ Time Frame: Change from Baseline to 52 weeks ] [ Designated as safety issue: No ]
  • Change in cognitive function [ Time Frame: Change from Baseline to Week 52 ] [ Designated as safety issue: No ]
    cognitive ability to be measured using confirmatory factor analysis (CFA). CFA aggregates scores from across multiple subtests.


Estimated Enrollment: 100
Study Start Date: November 2013
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02000583

Locations
United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Angela Van Sciver    913-945-5029    AVANSCIVER@kumc.edu   
Sponsors and Collaborators
University of Kansas
Investigators
Principal Investigator: Jeffrey Burns, MD University of Kansas
  More Information

No publications provided

Responsible Party: University of Kansas
ClinicalTrials.gov Identifier: NCT02000583     History of Changes
Other Study ID Numbers: 13376, R01AG043962-01
Study First Received: November 26, 2013
Last Updated: June 26, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kansas:
Alzheimer's Disease
AD
Aerobic Exercise
Exercise

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 29, 2014