Genes, Exercise, Memory and Neurodegeneration

NCT ID: NCT01021644

Last Updated: 2014-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2013-12-31

Brief Summary

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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

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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.

Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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aerobic exercise-training

Group Type EXPERIMENTAL

aerobic exercise-training

Intervention Type BEHAVIORAL

3 times per week for 6 months

stretch exercise

Group Type ACTIVE_COMPARATOR

stretch exercise

Intervention Type BEHAVIORAL

3 times per week for 6 months

Interventions

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aerobic exercise-training

3 times per week for 6 months

Intervention Type BEHAVIORAL

stretch exercise

3 times per week for 6 months

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Howard University

OTHER

Sponsor Role lead

Responsible Party

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Thomas Obisesan

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thomas O. Obisesan, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Howard University

Locations

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Howard University General Clinical Research Center (GCRC)

Washington D.C., District of Columbia, United States

Site Status

Temple University Exercise Physiology Laboratory

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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Lautenschlager NT, Cox KL, Flicker L, Foster JK, van Bockxmeer FM, Xiao J, Greenop KR, Almeida OP. Effect of physical activity on cognitive function in older adults at risk for Alzheimer disease: a randomized trial. JAMA. 2008 Sep 3;300(9):1027-37. doi: 10.1001/jama.300.9.1027.

Reference Type BACKGROUND
PMID: 18768414 (View on PubMed)

Barnes LL, Wilson RS, Li Y, Gilley DW, Bennett DA, Evans DA. Change in cognitive function in Alzheimer's disease in African-American and white persons. Neuroepidemiology. 2006;26(1):16-22. doi: 10.1159/000089231. Epub 2005 Oct 25.

Reference Type BACKGROUND
PMID: 16254449 (View on PubMed)

Wilkins CH, Grant EA, Schmitt SE, McKeel DW, Morris JC. The neuropathology of Alzheimer disease in African American and white individuals. Arch Neurol. 2006 Jan;63(1):87-90. doi: 10.1001/archneur.63.1.87.

Reference Type BACKGROUND
PMID: 16401740 (View on PubMed)

Larson EB, Wang L, Bowen JD, McCormick WC, Teri L, Crane P, Kukull W. Exercise is associated with reduced risk for incident dementia among persons 65 years of age and older. Ann Intern Med. 2006 Jan 17;144(2):73-81. doi: 10.7326/0003-4819-144-2-200601170-00004.

Reference Type BACKGROUND
PMID: 16418406 (View on PubMed)

Kramer AF, Erickson KI, Colcombe SJ. Exercise, cognition, and the aging brain. J Appl Physiol (1985). 2006 Oct;101(4):1237-42. doi: 10.1152/japplphysiol.00500.2006. Epub 2006 Jun 15.

Reference Type BACKGROUND
PMID: 16778001 (View on PubMed)

Other Identifiers

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1R01AG031517-01A209

Identifier Type: -

Identifier Source: secondary_id

1R01AG031517-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IA0172

Identifier Type: -

Identifier Source: org_study_id

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