Genes, Exercise, Memory and Neurodegeneration

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. 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

November 25, 2009
November 30, 2009
February 14, 2014
October 2009
December 2013   (Final data collection date for primary outcome measure)
AD Assessment Scale-Cognitive (ADAS-COG) [ Time Frame: baseline, 3 and 6 months ]
Same as current
Complete list of historical versions of study NCT01021644 on Archive Site
  • Mini-Mental State Exam (MMSE) [ Time Frame: baseline, 3 and 6 months ]
  • CDR (Clinical Dementia Rating) Scale [ Time Frame: baseline, 3 and 6 months ]
  • Logical Memory Test (Delayed Paragraph Recall) [ Time Frame: baseline and 6 months ]
  • Visuospatial and Visuographic: Clock Drawing Test [ Time Frame: baseline and 6 months ]
  • American National Adult Reading Test (ANART) [ Time Frame: baseline and 6 months ]
  • Neuropsychiatric Inventory Q (NPIQ) [ Time Frame: baseline and 6 months ]
  • Geriatric Depression Scale [ Time Frame: baseline and 6 months ]
  • Activities of Daily Living (ADCS-ADL) [ Time Frame: baseline and 6 months ]
  • PET imaging to measure cerebral glucose homeostasis/metabolism [ Time Frame: baseline and 6 months ]
Same as current
Not Provided
Not Provided
Genes, Exercise, Memory and Neurodegeneration
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.
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.
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Alzheimer's Disease
  • Behavioral: aerobic exercise-training
    3 times per week for 6 months
  • Behavioral: stretch exercise
    3 times per week for 6 months
  • Experimental: aerobic exercise-training
    Intervention: Behavioral: aerobic exercise-training
  • Active Comparator: stretch exercise
    Intervention: Behavioral: stretch exercise

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2013
December 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
60 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
1R01AG031517-01 ( U.S. NIH Grant/Contract )
Not Provided
Not Provided
Thomas Obisesan, Howard University
Howard University
Not Provided
Principal Investigator: Thomas O. Obisesan, MD, MPH Howard University
Howard University
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP