Trial record 1 of 1 for:    Effects of Standardized Aerobic Exercise Training on Neurocognitive and Neurodegeneration
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Genes, Exercise, Memory and Neurodegeneration

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Thomas Obisesan, Howard University
ClinicalTrials.gov Identifier:
NCT01021644
First received: November 25, 2009
Last updated: February 13, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Alzheimer's Disease
Behavioral: aerobic exercise-training
Behavioral: stretch exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Standardized Aerobic Exercise-Training on Neurocognitive and Neurodegeneration

Resource links provided by NLM:


Further study details as provided by Howard University:

Primary Outcome Measures:
  • AD Assessment Scale-Cognitive (ADAS-COG) [ Time Frame: baseline, 3 and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mini-Mental State Exam (MMSE) [ Time Frame: baseline, 3 and 6 months ] [ Designated as safety issue: No ]
  • CDR (Clinical Dementia Rating) Scale [ Time Frame: baseline, 3 and 6 months ] [ Designated as safety issue: No ]
  • Logical Memory Test (Delayed Paragraph Recall) [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
  • Visuospatial and Visuographic: Clock Drawing Test [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
  • American National Adult Reading Test (ANART) [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
  • Neuropsychiatric Inventory Q (NPIQ) [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
  • Geriatric Depression Scale [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
  • Activities of Daily Living (ADCS-ADL) [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
  • PET imaging to measure cerebral glucose homeostasis/metabolism [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]

Enrollment: 73
Study Start Date: October 2009
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01021644

Locations
United States, District of Columbia
Howard University General Clinical Research Center (GCRC)
Washington, District of Columbia, United States, 20060
United States, Pennsylvania
Temple University Exercise Physiology Laboratory
Philadelphia, Pennsylvania, United States, 19140
Sponsors and Collaborators
Howard University
Investigators
Principal Investigator: Thomas O. Obisesan, MD, MPH Howard University
  More Information

Publications:
Responsible Party: Thomas Obisesan, Professor of Medicine, Howard University
ClinicalTrials.gov Identifier: NCT01021644     History of Changes
Other Study ID Numbers: IA0172, 1R01AG031517-01A209
Study First Received: November 25, 2009
Last Updated: February 13, 2014
Health Authority: United States: Federal Government

Keywords provided by Howard University:
APOE
Apolipoprotein E
Cognition Disorders
Neurocognition

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

ClinicalTrials.gov processed this record on August 20, 2014