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

November 25, 2009
February 13, 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01021644 on ClinicalTrials.gov Archive Site
  • 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 ]
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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
73
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
Both
60 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01021644
IA0172, 1R01AG031517-01A209
Yes
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