Recruiting
Phase 2

Exercise

Sponsor:

Rutgers, The State University of New Jersey

Code:

NCT05597124

Conditions

Aging

Alzheimer Disease

Healthy Aging

Cognitive Change

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Accepted

Interventions

Cardio-Dance Fitness

Strength, Flexibility & Balance

Study Details

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.

Conditions

Aging

Alzheimer Disease

Healthy Aging

Cognitive Change

Study ID

NCT05597124

Start date

Apr 20, 2023

Status verified date

Feb, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Accepted

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 Design

Enrollment

280 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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).

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).

Interventions

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).

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 outcome measure

  • Generalization Performance on the Concurrent Discrimination and Transfer Task [ Time Frame: Changes from baseline to six months ]
  • Generalization Performance on the Acquired Equivalence Task [ Time Frame: Changes from baseline to six months ]
  • Medial Temporal Lobe Neural Flexibility [ Time Frame: Changes from baseline to six months ]

Central Contacts and Locations

Central contacts

Bernadette A. Fausto, PhD

(973) 944-0775bernadette.fausto@rutgers.edu

Jennifer Greene, MPH

(973) 353-2257jag644@rutgers.edu

Locations

Rutgers, The State University of New Jersey - Newark campus

Recruiting

Newark, New Jersey, United States, 07102

Contacts

Lisa Haber-Chalom

lhchalom@newark.rutgers.edu

Principal Investigator:

Mark A. Gluck, PhD

More Information

Sponsor

Rutgers, The State University of New Jersey

Last update posted

Feb 20, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rutgers, The State University of New Jersey on 2026-02-20.