Exercise to Reduce Alzheimer's Risk in Older African Americans
Reducing African Americans' Alzheimer's Disease Risk Through Exercise-Mild Cognitive Impairment Cohort
This study is testing if a structured exercise program can help older African American adults lower their risk of Alzheimer's disease and improve their brain health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 144 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Pennington Biomedical Research Center Academic / other |
| Locations | 1 site (Baton Rouge, Louisiana) |
| Trial ID | NCT04956549 on ClinicalTrials.gov |
What this trial studies
The RAATE-MCI initiative aims to investigate the impact of physical activity on Alzheimer's disease risk factors among older African American adults. This 52-week randomized controlled trial will compare a structured physical activity program with an active control group focused on successful aging. A total of 144 participants aged 60 and older will be recruited, and outcomes will be assessed at baseline, 24 weeks, and 52 weeks. The study seeks to enhance cognitive function and modify neurobiological pathways associated with Alzheimer's through regular exercise.
Who should consider this trial
Good fit: Ideal candidates for this study are African American adults aged 60 and older who are physically capable of exercise and have not engaged in regular physical activity.
Not a fit: Patients with uncontrolled medical conditions that make regular exercise unsafe or those who are already physically active may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the risk of Alzheimer's disease in older African American adults through increased physical activity.
How similar studies have performed: Previous studies have shown that physical activity can enhance cognitive function in older adults, suggesting that this approach may be effective in reducing Alzheimer's risk.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. are African American (self-identify) 2. are 60 and older 3. are physically capable of exercise 4. are willing to accept randomization 5. are willing to attend group sessions 6. plan to live in the study area over the next 13 months and capable of traveling to designated study facility for clinic visits and intervention sessions for the next year 7. are free of conditions (e.g. uncontrolled asthma, severe sickle cell disease, etc.) that would make regular exercise unsafe as deemed by the medical investigator 8. have not engaged in regular physical activity 9. have a Short Physical Performance Battery ≥4 10. physically capable of exercise 11. are unable to utilize devices and/or applications as required for study participation 12. willing to attend group sessions 13. willing to allow researchers to use data for research purposes after study participation is completed 14. meet criteria for MCI as defined by the NIA-AA research framework a. cognitive performance below normal range (score \< 1.5 SDs below the mean on NIH Toolbox scores for their age and sex on at least one of the subtests) Exclusion Criteria: 1. have cognitive impairment that would interfere with participating in a group discussion a. cognitive performance in the demented range (score \< 3 SDs below the mean on NIH Toolbox scores for their age and sex on at least one of the subtests) 2. meet criteria for dementia 3. are unwilling to give written informed consent or accept randomization in either study group 4. are too active (as defined by ≥10 min bouts of MVPA as measured by Actigraph) if: 1. Sum of MVPA bouts for the 7 day wear period ≥40 mins 2. Or ≤40 mins of MVPA 10min bouts AND ≥3 days of bouts 5. have uncontrolled hypertension (systolic blood pressure \> 150 mmHg and/or diastolic blood pressure \> 90 mmHg). 6. have had a myocardial infarction, major heart surgery (i.e., valve replacement or bypass surgery), stroke, deep vein thrombosis, pulmonary embolus, hip fracture, hip or knee replacement, or spinal surgery in the past 6 months 7. are undergoing cardiopulmonary rehabilitation 8. have uncontrolled diabetes that in the judgment of the MI may interfere with study participation 9. have clinically diagnosed osteoporosis that in the judgment of the MI may interfere with study participation 10. are currently enrolled in another randomized trial involving lifestyle or pharmaceutical interventions 11. have another member of the household that is a participant in RAATE or RAATE MCI 12. refuse to participate in the study without disclosure of their amyloid PET scan results 13. refuse to allow anonymized versions of their study data for research after this study is completed. 14. have other medical, psychiatric, or behavioral factors that in the judgment of the Principal or Medical Investigator may interfere with study participation or the ability to follow the intervention protocol
Where this trial is running
Baton Rouge, Louisiana
- Pennington Biomedical Research — Baton Rouge, Louisiana, United States (Recruiting)
Study contacts
- Principal investigator: Robert L Newton, Jr., PhD — Pennington Biomedical Research
- Study coordinator: Callie Hebert, MS
- Email: callie.hebert@pbrc.edu
- Phone: 225-763-2362
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.