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Genes, Exercise, Memory and Neurodegeneration

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ClinicalTrials.gov Identifier: NCT01021644
Recruitment Status : Completed
First Posted : November 30, 2009
Last Update Posted : February 14, 2014
Information provided by (Responsible Party):
Thomas Obisesan, Howard University

Brief Summary:
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 or disease Intervention/treatment Phase
Alzheimer's Disease Behavioral: aerobic exercise-training Behavioral: stretch exercise Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Standardized Aerobic Exercise-Training on Neurocognitive and Neurodegeneration
Study Start Date : October 2009
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

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

Primary Outcome Measures :
  1. AD Assessment Scale-Cognitive (ADAS-COG) [ Time Frame: baseline, 3 and 6 months ]

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

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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): NCT01021644

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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
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Principal Investigator: Thomas O. Obisesan, MD, MPH Howard University
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Responsible Party: Thomas Obisesan, Professor of Medicine, Howard University
ClinicalTrials.gov Identifier: NCT01021644    
Other Study ID Numbers: IA0172
1R01AG031517-01 ( U.S. NIH Grant/Contract )
First Posted: November 30, 2009    Key Record Dates
Last Update Posted: February 14, 2014
Last Verified: February 2014
Keywords provided by Thomas Obisesan, Howard University:
Apolipoprotein E
Cognition Disorders
Additional relevant MeSH terms:
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Alzheimer Disease
Nerve Degeneration
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Pathologic Processes