Clinical trial NCT01021644: Genes, Exercise, Memory and Neurodegeneration
Official title: Effects of Standardized Aerobic Exercise-Training on Neurocognitive and Neurodegeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer's Disease
Keywords: APOE
Apolipoprotein E
Cognition Disorders
Neurocognition
Lead sponsor: Howard University
Sponsor class: OTHER
First posted: 2009-11-30
Enrollment: 73
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: AD Assessment Scale-Cognitive (ADAS-COG)
timeFrame: baseline, 3 and 6 months
Secondary outcomes:
measure: Mini-Mental State Exam (MMSE)
timeFrame: baseline, 3 and 6 months
measure: CDR (Clinical Dementia Rating) Scale
timeFrame: baseline, 3 and 6 months
measure: Logical Memory Test (Delayed Paragraph Recall)
timeFrame: baseline and 6 months
measure: Visuospatial and Visuographic: Clock Drawing Test
timeFrame: baseline and 6 months
measure: American National Adult Reading Test (ANART)
timeFrame: baseline and 6 months
measure: Neuropsychiatric Inventory Q (NPIQ)
timeFrame: baseline and 6 months
measure: Geriatric Depression Scale
timeFrame: baseline and 6 months
measure: Activities of Daily Living (ADCS-ADL)
timeFrame: baseline and 6 months
measure: PET imaging to measure cerebral glucose homeostasis/metabolism
timeFrame: baseline and 6 months
Other outcomes:
Locations:
city: Washington
country: United States
facility: Howard University General Clinical Research Center (GCRC)
state: District of Columbia
city: Philadelphia
country: United States
facility: Temple University Exercise Physiology Laboratory
state: Pennsylvania
Study officials:
affiliation: Howard University
name: Thomas O. Obisesan, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.