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Genes, Exercise, Memory and Neurodegeneration

Effects of Standardized Aerobic Exercise-Training on Neurocognitive and Neurodegeneration

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01021644
Enrollment
73
Registered
2009-11-30
Start date
2009-10-31
Completion date
2013-12-31
Last updated
2014-02-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

Keywords

APOE, Apolipoprotein E, Cognition Disorders, Neurocognition

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.

Interventions

BEHAVIORALaerobic exercise-training

3 times per week for 6 months

3 times per week for 6 months

Sponsors

Howard University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
AD Assessment Scale-Cognitive (ADAS-COG)baseline, 3 and 6 months

Secondary

MeasureTime frame
CDR (Clinical Dementia Rating) Scalebaseline, 3 and 6 months
Logical Memory Test (Delayed Paragraph Recall)baseline and 6 months
Visuospatial and Visuographic: Clock Drawing Testbaseline and 6 months
American National Adult Reading Test (ANART)baseline and 6 months
Mini-Mental State Exam (MMSE)baseline, 3 and 6 months
Geriatric Depression Scalebaseline and 6 months
Activities of Daily Living (ADCS-ADL)baseline and 6 months
PET imaging to measure cerebral glucose homeostasis/metabolismbaseline and 6 months
Neuropsychiatric Inventory Q (NPIQ)baseline and 6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026