- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05597124
Exercise to Improve Brain Health in Older African Americans
Determinants of Individual Differences in the Efficacy of Aerobic Exercise to Improve Brain Health and Reduce Alzheimer's Disease Risk in Older African Americans
The goal of this clinical trial is to test the effects of different types of exercise on brain health and Alzheimer's risk in older African Americans.
Specifically, the main question[s] it aims to answer are:
- What is the effect of a Cardio-Dance Fitness (CDF) vs. a Strength, Flexibility, and Balance (SFB) intervention on a cognitive marker of Alzheimer's risk, generalization?
- What is the effect of the CDF vs. SFB intervention on a fMRI biomarker of Alzheimer's, neural flexibility, and do improvements in neural flexibility mediate improvements in generalization?
- Do ABCA7 genotypic variations moderate the efficacy of the CDF vs. SFB intervention for reducing Alzheimer's risk?
Participants will undergo-- at baseline and post-test-- health assessments, cognitive tests, and structural and functional magnetic resonance imaging (fMRI), and a blood-draw to assess Alzheimer's risk biomarker levels.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
New Jersey
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Newark, New Jersey, United States, 07102
- Rutgers, The State University of New Jersey - Newark campus
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- self-identify as either African American or Black;
- be age 60 or older;
- able to speak, read, and understand English;
- available over the study period; independently ambulatory (i.e., not needing a wheelchair, walker, or cane);
- meet criteria for low levels of physical activity (less than 60 minutes per week) based on the International Physical Activity Questionnaire (IPAQ-short version);
- scoring 28-35 (inclusive) on the Telephone Interview for Cognitive Status Modified (sensitivity [43%], specificity [94%] for lower threshold; sensitivity [93%], specificity [42%] for upper threshold)55.
- scoring 20-26 (inclusive) on the Montreal Cognitive Assessment (MoCA) during the in-person screening
- have clearance to participate from their primary care physician, with oversight of all our patient health under the guidance of our physician-scientist Co-I, William Hu, Chief of Cognitive Neurology at Rutgers.
Exclusion Criteria:
- color-blindness (because some of our tasks utilize color as a cue);
- any diagnosed neurological disorder (including headaches and peripheral neuropathy); diagnosed or self-reported non-neurological conditions that likely affect MTL outcomes, such as, major depressive disorder (or a Geriatric Depression Scale-Short Form score ≥ 5), schizophrenia, delusional disorder, schizoaffective disorder or significant psychiatric symptoms that could impair the completion of the study (e.g., psychosis), substance-related and addictive disorders (or treatment in past five years), chemotherapy or radiation treatment for cancers, planning to undergo general anesthesia during the study period;
- exercise contraindications, such as, orthopedic complications, myocardial infarction, coronary artery bypass grafting, angioplasty or other cardiac condition in the past year, current treatment for congestive heart failure, angina, uncontrolled arrhythmia, deep vein thrombosis (DVT) or another cardiovascular event, and uncontrolled hypertension with resting systolic or diastolic blood pressures > 180/110 mmHg.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cardio-Dance Fitness
This is the experimental group.
Participants will meet three times a week for dance classes for approximately 60 minutes per session, over 24 weeks (approximately 6 months).
|
This is an aerobic cardio-dance fitness exercise class in a social context with aerobic intensity assessed by heart rate monitoring throughout the class.
Participants will meet three times a week for approximately 60 minutes per session, over 24 weeks (approximately 6 months).
Other Names:
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Active Comparator: Strength, Flexibility & Balance
This is the active control group.
Participants will meet three times a week for strength, flexibility, and balance exercises for approximately 60 minutes per session, over 24 weeks (approximately 6 months).
|
This intervention will serve as a stringent, structurally equivalent, active comparator to the CDF intervention, identical in duration, frequency, and social contact except for the content of this non-aerobic intervention.
SFB will involve non-aerobic activity with strength, flexibility, and balance training.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Generalization Performance on the Concurrent Discrimination and Transfer Task
Time Frame: Changes from baseline to six months
|
The Concurrent Discrimination and Transfer Task (a task that indexes generalization, the ability to apply past learning to novel task demands) will be administered at baseline, and then following the intervention (6-months).
The main outcome from this task is the number transfer errors.
A higher score indicates worse generalization.
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Changes from baseline to six months
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Generalization Performance on the Acquired Equivalence Task
Time Frame: Changes from baseline to six months
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The Acquired Equivalence Task (a task that indexes generalization, the ability to apply past learning to novel task demands) will be administered at baseline, and then following the intervention (6-months).
The main outcome from this task is generalization accuracy.
A higher score indicates better generalization.
|
Changes from baseline to six months
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Medial Temporal Lobe Neural Flexibility
Time Frame: Changes from baseline to six months
|
Medial Temporal Lobe Neural Flexibility is a measure of synchrony via fMRI resting-state analyses in the hippocampus and other medial temporal lobe brain regions for encoding new memories. Flexibility is quantified as the number of times a node displayed a change in community assignment, normalized by the total possible number of changes; this will be computed for each of our seven regions of interest in the medial temporal lobe. A higher score indicates greater flexibility. The flexibility of the MTL network as a whole was then computed as the mean flexibility over all nodes. |
Changes from baseline to six months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Exploratory Outcome: AB 42/40
Time Frame: Changes from baseline to six months
|
The ratio of 42 to 40 amino acid-long amyloid β, a marker of plaque pathology, will be examined as an exploratory outcome.
Lower values indicate more AB 42/40 pathology.
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Changes from baseline to six months
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Exploratory Outcome: p-tau181
Time Frame: Changes from baseline to six months
|
Phosphorylated tau 181, a marker of AD-related tau phosphorylation and secretion, will be examined as an exploratory outcome.
Higher values indicate more tau pathology.
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Changes from baseline to six months
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Exploratory Outcome: p-tau231
Time Frame: Changes from baseline to six months
|
Phosphorylated tau 231, a marker of AD-related tau phosphorylation and secretion, will be examined as an exploratory outcome.
Higher values indicate more tau pathology.
|
Changes from baseline to six months
|
Exploratory Outcome: Neurofilament-light Chain
Time Frame: Changes from baseline to six months
|
Neurofilament-light chain (NfL) is a neuronal cytoplasmic protein; its levels increase in plasma and cerebrospinal fluid proportional to the degree of axonal damage in a variety of neurological disorders, including Alzheimer's disease.
Higher values indicate greater axonal damage.
|
Changes from baseline to six months
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Collaborators and Investigators
Investigators
- Principal Investigator: Mark A. Gluck, PhD, Rutgers, The State University of New Jersey - Newark campus
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro2022001256
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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