Genes, Exercise, Memory and Neurodegeneration

Alzheimer's Disease Clinical Trial

Official title:

Effects of Standardized Aerobic Exercise-Training on Neurocognitive and Neurodegeneration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01021644
• Other study ID #: IA0172
• Secondary ID: 1R01AG031517-01A
• Status: Completed
• Phase: N/A
• First received: November 25, 2009
• Last updated: February 13, 2014
• Start date: October 2009
• Est. completion date: December 2013

Study information

• Verified date: February 2014
• Source: Howard University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Nerve Degeneration

Intervention

Behavioral:
• aerobic exercise-training
3 times per week for 6 months
• stretch exercise
3 times per week for 6 months

Locations

Country	Name	City	State
United States	Temple University Exercise Physiology Laboratory	Philadelphia	Pennsylvania
United States	Howard University General Clinical Research Center (GCRC)	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Howard University

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. Epub 2005 Oct 25. — View Citation

Kramer AF, Erickson KI, Colcombe SJ. Exercise, cognition, and the aging brain. J Appl Physiol (1985). 2006 Oct;101(4):1237-42. Epub 2006 Jun 15. Review. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AD Assessment Scale-Cognitive (ADAS-COG)		baseline, 3 and 6 months	No
Secondary	Mini-Mental State Exam (MMSE)		baseline, 3 and 6 months	No
Secondary	CDR (Clinical Dementia Rating) Scale		baseline, 3 and 6 months	No
Secondary	Logical Memory Test (Delayed Paragraph Recall)		baseline and 6 months	No
Secondary	Visuospatial and Visuographic: Clock Drawing Test		baseline and 6 months	No
Secondary	American National Adult Reading Test (ANART)		baseline and 6 months	No
Secondary	Neuropsychiatric Inventory Q (NPIQ)		baseline and 6 months	No
Secondary	Geriatric Depression Scale		baseline and 6 months	No
Secondary	Activities of Daily Living (ADCS-ADL)		baseline and 6 months	No
Secondary	PET imaging to measure cerebral glucose homeostasis/metabolism		baseline and 6 months	No