NCT01021644

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 30, 2009

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

February 14, 2014

Status Verified

February 1, 2014

Enrollment Period

4.2 years

First QC Date

November 25, 2009

Last Update Submit

February 13, 2014

Conditions

Alzheimer's Disease

Keywords

APOEApolipoprotein ECognition DisordersNeurocognition

Outcome Measures

Primary Outcomes (1)

  • AD Assessment Scale-Cognitive (ADAS-COG)

    baseline, 3 and 6 months

Secondary Outcomes (9)

  • Mini-Mental State Exam (MMSE)

    baseline, 3 and 6 months

  • CDR (Clinical Dementia Rating) Scale

    baseline, 3 and 6 months

  • Logical Memory Test (Delayed Paragraph Recall)

    baseline and 6 months

  • Visuospatial and Visuographic: Clock Drawing Test

    baseline and 6 months

  • American National Adult Reading Test (ANART)

    baseline and 6 months

  • +4 more secondary outcomes

Study Arms (2)

aerobic exercise-training

EXPERIMENTAL
Behavioral: aerobic exercise-training

stretch exercise

ACTIVE COMPARATOR
Behavioral: stretch exercise

Interventions

aerobic exercise-trainingBEHAVIORAL

3 times per week for 6 months

aerobic exercise-training
stretch exerciseBEHAVIORAL

3 times per week for 6 months

stretch exercise

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Howard University General Clinical Research Center (GCRC)

Washington D.C., District of Columbia, 20060, United States

Location

Temple University Exercise Physiology Laboratory

Philadelphia, Pennsylvania, 19140, United States

Location

Related Publications (5)

  • 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.

    PMID: 18768414BACKGROUND

  • 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.

    PMID: 16254449BACKGROUND

  • 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.

    PMID: 16401740BACKGROUND

  • 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.

    PMID: 16418406BACKGROUND

  • 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.

    PMID: 16778001BACKGROUND

MeSH Terms

Conditions

Alzheimer DiseaseCognition Disorders

Interventions

Plyometric Exercise

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Thomas O. Obisesan, MD, MPH

    Howard University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

November 25, 2009

First Posted

November 30, 2009

Study Start

October 1, 2009

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

February 14, 2014

Record last verified: 2014-02

Locations

US(2)