NCT05597124 Exercise to Improve Brain Health in Older African Americans
| NCT ID | NCT05597124 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Rutgers, The State University of New Jersey |
| Condition | Aging |
| Study Type | INTERVENTIONAL |
| Enrollment | 280 participants |
| Start Date | 2023-04-20 |
| Primary Completion | 2027-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 280 participants in total. It began in 2023-04-20 with a primary completion date of 2027-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Mark A. Gluck, PhD
PRINCIPAL INVESTIGATOR
Rutgers, The State University of New Jersey - Newark campus
Frequently Asked Questions
Who can join the NCT05597124 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Aging. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05597124 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05597124 currently recruiting?
Yes, NCT05597124 is actively recruiting participants. Contact the research team at bernadette.fausto@rutgers.edu for enrollment information.
Where is the NCT05597124 trial being conducted?
This trial is being conducted at Newark, United States.
Who is sponsoring the NCT05597124 clinical trial?
NCT05597124 is sponsored by Rutgers, The State University of New Jersey. The principal investigator is Mark A. Gluck, PhD at Rutgers, The State University of New Jersey - Newark campus. The trial plans to enroll 280 participants.