Genes, Exercise, Memory and Neurodegeneration

February 13, 2014 updated by: Thomas Obisesan, Howard University

Effects of Standardized Aerobic Exercise-Training on Neurocognitive and Neurodegeneration

The primary purpose of this pilot study is to determine whether African Americans with mild Alzheimer's disease (AD) can be enrolled and retained in a 6-month aerobic exercise-training study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will examine the effects of aerobic exercise-training on neurocognitive function, and on cerebral glucose homeostasis. It is yet to be determined whether African Americans with mild AD can be recruited into such a study, nor has the relationship of fitness adaptation to neurocognitive function been systematically examined in this population. In addition to the goal of assessing the intervention effects, the study will evaluate the differential relationships of APOE to aerobic fitness-induced changes in neurocognition. The long-term goal is to explore the mechanism by which fitness adaptation exerts an effect on neurocognition, notably, low levels of high-density lipoprotein cholesterol (HDL-C), elevated inflammation (C-reactive protein (CRP) and interleukins (IL-1A)), deranged glucose homeostasis, hypertension and endothelia dysfunction are precursors of arteriolosclerosis, decreased cerebral perfusion and oxygen deprivation, all of which may increase AD risk. Because many of these putative AD risk factors are susceptible to lifestyle alterations, the study will also assess their roles in aerobic fitness-related improvements in cognitive function and reduction in AD risk.

Study Type

Interventional

Enrollment (Actual)

73

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20060
        • Howard University General Clinical Research Center (GCRC)
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University Exercise Physiology Laboratory

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age over 60 years
  • Ability to exercise vigorously without harm
  • Mild AD
  • Study partner
  • In good general health
  • Willing to exercise for 6 months
  • Body Mass Index (BMI) less than 37
  • Women participants must be postmenopausal for at least 2 years, and maintain current hormone replacement therapy status and allowed medication usage for the duration of the study

Exclusion Criteria:

  • MMSE score below 20
  • TG (Triglyceride) greater than 400 mg/dl
  • LDL-C levels greater than 95% or HDL-C levels less than 10% of age and sex-adjusted norms

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: aerobic exercise-training
Behavioral: aerobic exercise-training
3 times per week for 6 months
Active Comparator: stretch exercise
Behavioral: stretch exercise
3 times per week for 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
AD Assessment Scale-Cognitive (ADAS-COG)
Time Frame: baseline, 3 and 6 months
baseline, 3 and 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Mini-Mental State Exam (MMSE)
Time Frame: baseline, 3 and 6 months
baseline, 3 and 6 months
CDR (Clinical Dementia Rating) Scale
Time Frame: baseline, 3 and 6 months
baseline, 3 and 6 months
Logical Memory Test (Delayed Paragraph Recall)
Time Frame: baseline and 6 months
baseline and 6 months
Visuospatial and Visuographic: Clock Drawing Test
Time Frame: baseline and 6 months
baseline and 6 months
American National Adult Reading Test (ANART)
Time Frame: baseline and 6 months
baseline and 6 months
Neuropsychiatric Inventory Q (NPIQ)
Time Frame: baseline and 6 months
baseline and 6 months
Geriatric Depression Scale
Time Frame: baseline and 6 months
baseline and 6 months
Activities of Daily Living (ADCS-ADL)
Time Frame: baseline and 6 months
baseline and 6 months
PET imaging to measure cerebral glucose homeostasis/metabolism
Time Frame: baseline and 6 months
baseline and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Howard University

Investigators

  • Principal Investigator: Thomas O. Obisesan, MD, MPH, Howard University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

November 25, 2009

First Submitted That Met QC Criteria

November 25, 2009

First Posted (Estimate)

November 30, 2009

Study Record Updates

Last Update Posted (Estimate)

February 14, 2014

Last Update Submitted That Met QC Criteria

February 13, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IA0172
  • 1R01AG031517-01A209
  • 1R01AG031517-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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