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Genes, Exercise, Memory and Neurodegeneration

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
aerobic exercise-training
stretch exercise
Sponsored by
Howard University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring APOE, Apolipoprotein E, Cognition Disorders, Neurocognition

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Howard University General Clinical Research Center (GCRC)
  • Temple University Exercise Physiology Laboratory

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

aerobic exercise-training

stretch exercise

Arm Description

Outcomes

Primary Outcome Measures

AD Assessment Scale-Cognitive (ADAS-COG)

Secondary Outcome Measures

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

Full Information

First Posted
November 25, 2009
Last Updated
February 13, 2014
Sponsor
Howard University
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1. Study Identification

Unique Protocol Identification Number
NCT01021644
Brief Title
Genes, Exercise, Memory and Neurodegeneration
Official Title
Effects of Standardized Aerobic Exercise-Training on Neurocognitive and Neurodegeneration
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Howard University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
APOE, Apolipoprotein E, Cognition Disorders, Neurocognition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
aerobic exercise-training
Arm Type
Experimental
Arm Title
stretch exercise
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
aerobic exercise-training
Intervention Description
3 times per week for 6 months
Intervention Type
Behavioral
Intervention Name(s)
stretch exercise
Intervention Description
3 times per week for 6 months
Primary Outcome Measure Information:
Title
AD Assessment Scale-Cognitive (ADAS-COG)
Time Frame
baseline, 3 and 6 months
Secondary Outcome Measure Information:
Title
Mini-Mental State Exam (MMSE)
Time Frame
baseline, 3 and 6 months
Title
CDR (Clinical Dementia Rating) Scale
Time Frame
baseline, 3 and 6 months
Title
Logical Memory Test (Delayed Paragraph Recall)
Time Frame
baseline and 6 months
Title
Visuospatial and Visuographic: Clock Drawing Test
Time Frame
baseline and 6 months
Title
American National Adult Reading Test (ANART)
Time Frame
baseline and 6 months
Title
Neuropsychiatric Inventory Q (NPIQ)
Time Frame
baseline and 6 months
Title
Geriatric Depression Scale
Time Frame
baseline and 6 months
Title
Activities of Daily Living (ADCS-ADL)
Time Frame
baseline and 6 months
Title
PET imaging to measure cerebral glucose homeostasis/metabolism
Time Frame
baseline and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas O. Obisesan, MD, MPH
Organizational Affiliation
Howard University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Howard University General Clinical Research Center (GCRC)
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20060
Country
United States
Facility Name
Temple University Exercise Physiology Laboratory
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18768414
Citation
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. Erratum In: JAMA. 2009 Jan 21;301(3):276.
Results Reference
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PubMed Identifier
16254449
Citation
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.
Results Reference
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PubMed Identifier
16401740
Citation
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.
Results Reference
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PubMed Identifier
16418406
Citation
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.
Results Reference
background
PubMed Identifier
16778001
Citation
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.
Results Reference
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Genes, Exercise, Memory and Neurodegeneration

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