Genes, Exercise, Neurocognitive and Neurodegeneration: Community-Based Approach

Status unconfirmed · Not applicable

Conditions studied: Mild Cognitive Impairment

In brief

Whereas the advantageous effects of exercise-training on memory is increasingly recognized, the practicality and clinical usefulness of such interventions in community-dwelling older African Americans (AA)s Mild Cognitively Impaired (MCI) subjects, and the mechanism by which an effect occurs need elucidation. Because aerobic-exercise can improve emerging cardiovascular (CVD)-related risk factors for cognitive decline such as lipids, inflammatory cytokines and glucose homeostasis; the Investigators will examine training effects on these and related biomarkers. The imperative for this study is further underscored by the fact that, AAs: i) have high rates of dementia, and ii) have paucity of cross-sectional, and lack prospective data on the effects of exercise on cognition. To overcome barriers to recruitment and retention, enhance compliance with a long exercise program (3-times/week), and maximize the use of available resources, the Investigators will use a community-based approach. Therefore, the primary objectives of this study build on the Investigators' experience, and will compare the effects of aerobic-exercise to stretch-exercise (control) in community-dwelling AA MCI subjects. Following the initial 6 months active intervention, the aerobic-exercise group will follow a prescribed but free living 40 minutes, 3 time/week exercise regimen while the control group returns to usual care plus stretch-exercise for additional 12 months. This study will facilitate the estimation of sample size for a larger confirmatory study in AAs. A newly acquired direct oversight of the DC Ward-6 Senior Wellness Center and its infrastructures by the Howard University Division of Geriatrics will provide additional resources and access to the community. In addition to the Investigator's feasibility aims, the Investigators will determine performance on cognitive tasks using the Alzheimer's Disease Assessment Scale-Cognitive Sub-scale (ADAS-Cog) and Clinical Dementia Rating Scale (CDR) sum of boxes supplemented by tests of executive function (EF) and Functional Activity Questionnaire (FA) and together as ADAS-Cog-Plus; changes in brain volume regions of interest (ROI) with Magnetic Resonance Imaging (MRI), selected CVD and AD-related bio-markers.

Key facts

Study ID: NCT02614365
Run by: Howard University
People needed: 80
Starts: 2014-07-01
Expected to finish: 2022-12-01
Last updated by the study team: 2021-03-02

Who can join

Age: 55 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

Age younger than 55 years
Scored below 24 on the MMSE (have dementia)
Have a Body Mass Index (BMI) ≥35,
If a woman and peri-menopausal and unwilling to maintain current hormone replacement therapy status and allowed medication usage during the study.
To avoid inaccurate HDL and HDL2-C determinations or avoid bias from familial hypercholesterolemia, respectively, participants with TG >400 mg/dl and those whose LDL-C levels >95% or HDL levels <10% of age and sex-adjusted norms will be excluded.
Excluded medications: Medications with significant effect on memory such as anticholinergic (diphenhydramine, tricyclic antidepressants, benztropine); sedative hypnotics such as benzodiazepines; narcotics; and antiparkinsonian medications will all be excluded.
Unstable medical conditions indicated by starting new medications within 6 weeks of enrollment will be disallowed.
Concomitant Medication: Medications used in the therapy of AD (Reminyl, Aricept, Exelon, Namenda, Gingko Biloba) will be allowed if stable on these medications for 6 weeks prior to enrollment.
Excluded Medical Diagnosis: To avoid misclassification bias, the Investigator will exclude persons with neurological, psychiatry or other clinical conditions likely to cause dementia. Participants having functional limitation preventing vigorous exercise, chronic disabling diseases, and alcoholism and drug abuse will be excluded.
Clinically significant cerebrovascular disease including cortical infarct, strategically located subcortical gray matter or extensive white matter abnormalities.
Treadmill screening exclusion criteria: include >2 mm ST depression, extra systole, chest pain, arrhythmias, hypotension and or dizziness or significant ST segment elevation during the treadmill test.

Where it is running

Howard University Clinical Research Unit — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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