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Clinical Trials/NCT01021644
NCT01021644
Completed
Not Applicable

Effects of Standardized Aerobic Exercise-Training on Neurocognitive and Neurodegeneration

Howard University2 sites in 1 country73 target enrollmentOctober 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Alzheimer's Disease
Sponsor
Howard University
Enrollment
73
Locations
2
Primary Endpoint
AD Assessment Scale-Cognitive (ADAS-COG)
Status
Completed
Last Updated
12 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
October 2009
End Date
December 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Thomas Obisesan

Professor of Medicine

Howard University

Eligibility Criteria

Inclusion Criteria

  • Age over 60 years
  • Ability to exercise vigorously without harm
  • 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

Outcomes

Primary Outcomes

AD Assessment Scale-Cognitive (ADAS-COG)

Time Frame: baseline, 3 and 6 months

Secondary Outcomes

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

Study Sites (2)

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