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Trial record 1 of 1 for:    NCT02614365
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Genes, Exercise, Neurocognitive and Neurodegeneration: Community-Based Approach (GEMSII)

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ClinicalTrials.gov Identifier: NCT02614365
Recruitment Status : Unknown
Verified September 2016 by Howard University.
Recruitment status was:  Recruiting
First Posted : November 25, 2015
Last Update Posted : October 6, 2016
Sponsor:
Collaborators:
University of Southern California
University of California, San Diego
Information provided by (Responsible Party):
Howard University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Behavioral: Aerobic exercise Behavioral: Stretch exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Genes, Exercise, Neurocognitive and Neurodegeneration: Community-Based Approach
Study Start Date : July 2014
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Aerobic Exercise
6-month 3-time/week aerobic exercise, and a 12-month passive follow-up.
Behavioral: Aerobic exercise
Cardiovascular fitness

Active Comparator: Stretch Exercise
6-month 3-time/week stretch exercise, and a 12-month passive follow-up.
Behavioral: Stretch exercise
Muscle stretch




Primary Outcome Measures :
  1. Neuropsychological assessments [ Time Frame: Change cognitive measures from baseline at 6 month ]
    Neuropsychological battery will be used to assess cognitive domains of interest.


Secondary Outcome Measures :
  1. Brain MRI-derived regions of interest assessed by change in regions of interest brain volume [ Time Frame: Change in regions of interest brain volume from baseline at 6 month and 12 month ]
    Brain MRI will be used as a screening tool and a measure brain volume

  2. Cardiovascular disease-related markers and biomarkers assessed by change in lipids (mg/dl) [ Time Frame: Change in lipids (mg/dl) from baseline at 3 month, 6 month, 9 month, 12 month and 18 month ]
    Cardiovascular disease related biomarkers.

  3. Cardiovascular disease-related markers and biomarkers assessed by change in Nuclear Magnetic Resonance Spectroscopy measured lipids concentrations (nml/L) [ Time Frame: Change in Nuclear Magnetic Resonance (NMR) Spectroscopy measured lipids concentrations (nml/L) from baseline at 3 month, 6 month, 9 month, 12 month and 18 month ]
    Cardiovascular disease related biomarkers.

  4. Cardiovascular disease-related markers and biomarkers assessed by change in cytokines' levels (pg/ml) [ Time Frame: Change in cytokines' levels (pg/ml) from baseline at 3 month, 6 month, 9 month, 12 month and 18 month ]
    Cardiovascular disease related biomarkers.

  5. Alzheimer's disease-related markers and biomarkers assessed by change in serum levels of Tau (ng/L) and Abeta (ng/L) [ Time Frame: Change in serum levels of Tau (ng/L) and Abeta (ng/L) from baseline to 3 month, 6 month, 9 month, 12 month and 18 month ]
    Cardiovascular disease and Alzheimer's disease related biomarkers.

  6. Alzheimer's disease-related markers and biomarkers assessed by change in CSF levels of Tau (ng/L) and Abeta (ng/L) [ Time Frame: Change in CSF levels of Tau (ng/L) and Abeta (ng/L) from baseline to 6 month. ]
    Cardiovascular disease and Alzheimer's Disease related biomarkers.

  7. Cardiovascular disease and Alzheimer's disease-related gene-environment interactions. [ Time Frame: Gene expression (fold change) from baseline at 3 month, 6 month, 9 month, 12 month and 18 month ]
    Cardiovascular disease and Alzheimer's disease related gene-environment interactions.

  8. Alzheimer's disease-related markers and biomarkers and their gene-environment interactions. [ Time Frame: Genotype at baseline ]
    Cardiovascular disease and Alzheimer's disease gene-environment interactions..

  9. Number of participants enrolled [ Time Frame: Number enrolled at baseline, and retained at 3 month, 6 month, 9 month,12 month and 18 month ]
    To test the feasibility of enrollment and retention of participants into a 6 month exercise study

  10. Number of participants accepting of spinal tap procedure [ Time Frame: Number of enrolled who had spinal tap at baseline and 6 month ]
    Acceptability of spinal tap procedure



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Main inclusion criteria:

  • Age > 55 years
  • Ability to exercise vigorously without causing harm to self
  • Have Mild Cognitive Impairment (MCI) as defined under diagnosis above
  • Have a study partner
  • Be in good general health
  • Willing to exercise for 12 months
  • Willingness to undergo neuropsychological evaluation, PET scan of the brain, and have blood drawn

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02614365


Contacts
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Contact: Sharlene Leong, BSc 202-865-1972 sharlene.leong@Howard.edu
Contact: Seyi Sowemimo, MSc, MPH 202-865-1905 oluwaseyi.sowemimo@howard.edu

Locations
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United States, District of Columbia
Howard University Clinical Research Unit Recruiting
Washington, District of Columbia, United States, 20060
Contact: Alice Ukaegbu, NP    202-865-4272    aukaegbu@Howard.edu   
Contact       aukaegbu@Howard.edu   
Principal Investigator: Thomas O. Obisesan, MD, MPH         
Sponsors and Collaborators
Howard University
University of Southern California
University of California, San Diego
Investigators
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Principal Investigator: Thomas O Obisesan, MD, MPH Howard University
Study Director: Oyanumo Ntekim, MD Howard University
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Responsible Party: Howard University
ClinicalTrials.gov Identifier: NCT02614365    
Other Study ID Numbers: 07-MED-41E
First Posted: November 25, 2015    Key Record Dates
Last Update Posted: October 6, 2016
Last Verified: September 2016
Additional relevant MeSH terms:
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Nerve Degeneration
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Pathologic Processes