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Completed

NCT Number: NCT01021644

Genes, Exercise, Memory 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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Howard University General Clinical Research Center (GCRC), Washington D.C., District of Columbia, United States

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About this 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

aerobic exercise-training

Behavioral

3 times per week for 6 months

stretch exercise

Behavioral

3 times per week for 6 months

Primary outcomes

  1. AD Assessment Scale-Cognitive (ADAS-COG)

    Time frame: baseline, 3 and 6 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Howard University

Other

Registry information

Official study title

Effects of Standardized Aerobic Exercise-Training on Neurocognitive and Neurodegeneration

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Nov 30, 2009
Registry last updated
Feb 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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