Determinants of Individual Differences in the Efficacy of Aerobic Exercise to Improve Brain Health and Reduce Alzheimer's Disease Risk in Older African Americans

Plain English Summary

Exercise to Improve Brain Health in Older African Americans is a Phase 2 clinical trial sponsored by Rutgers, The State University of New Jersey studying Aging, Alzheimer Disease, Healthy Aging, Cognitive Change. This trial tests if two different exercise programs, Cardio-Dance Fitness and Strength, Flexibility, and Balance, can improve brain health and lower the risk of Alzheimer's disease. It is for African American or Black individuals aged 60 and older who are not very physically active and have normal or slightly impaired memory. Participants will join one of the exercise groups for 24 weeks, attending sessions three times a week, and undergo health, cognitive, and brain imaging tests. Alternatives include maintaining current physical activity levels or participating in other community-based exercise programs not part of this study. The trial aims to enroll 280 participants.

Official 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. You can join if you are African American or Black, 60 years or older, can understand English, and are able to walk independently. You should also be doing less than 60 minutes of physical activity per week and have scores within a specific range on cognitive tests (Telephone Interview for Cognitive Status Modified and Montreal Cognitive Assessment). You cannot join if you have certain neurological disorders, significant psychiatric symptoms, recent cancer treatment, or medical conditions that would make exercise unsafe (e.g., recent heart attack, uncontrolled high blood pressure). This trial is studying Aging, Alzheimer Disease, Healthy Aging, Cognitive Change, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcomes measure how well participants can learn and apply new information (generalization) and how flexible their brain's memory centers are, which are key indicators of brain health and The specific primary outcome measures are: Generalization Performance on the Concurrent Discrimination and Transfer Task (Changes from baseline to six months); Generalization Performance on the Acquired Equivalence Task (Changes from baseline to six months); Medial Temporal Lobe Neural Flexibility (Changes from baseline to six months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.

Why This Trial Matters

This trial is important because it aims to find effective ways to protect brain health and reduce Alzheimer's risk in a community that is disproportionately affected by the disease. Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Aging, Alzheimer Disease, Healthy Aging, Cognitive Change, where improved treatment options are needed.

Investor Insight

This Phase 2 trial focuses on a specific demographic, suggesting a targeted approach to Alzheimer's prevention, with potential for future larger studies if successful. Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor if you are healthy enough to start a new exercise program. Be prepared to attend exercise sessions three times a week for about 60 minutes each, for six months. You will also have regular health check-ups, memory tests, and brain scans. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: TRIPLE
• Enrollment: 280 participants

Interventions

• BEHAVIORAL: Cardio-Dance Fitness — 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).
• BEHAVIORAL: Strength, Flexibility & Balance — 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.

Primary Outcomes

• Generalization Performance on the Concurrent Discrimination and Transfer Task (Changes from baseline to six months)
• Generalization Performance on the Acquired Equivalence Task (Changes from baseline to six months)
• Medial Temporal Lobe Neural Flexibility (Changes from baseline to six months)

Full 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.

Trial Locations

• Rutgers, The State University of New Jersey - Newark campus, Newark, New Jersey, United States

Frequently Asked Questions

Related Conditions

• Aging
• Alzheimer Disease
• Healthy Aging
• Cognitive Change
• Dementia
• Mild Cognitive Impairment
• Neurological Disorders
• Geriatric Depression
• Cardiovascular Health
• Physical Activity

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