NCT04956549 Reducing African American's Alzheimer's Risk Through Exercise-Mild Cognitive Impairment (RAATE-MCI)
| NCT ID | NCT04956549 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Pennington Biomedical Research Center |
| Condition | Dementia of Alzheimer Type |
| Study Type | INTERVENTIONAL |
| Enrollment | 144 participants |
| Start Date | 2021-06-01 |
| Primary Completion | 2026-03-31 |
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.
This trial targets 144 participants in total. It began in 2021-06-01 with a primary completion date of 2026-03-31.
⚠ 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 RAATE-MCI proposal is designed to determine the effects of physical activity on risk factors for Alzheimer's Disease in older African American adults. The study will compare a physical activity program to an active control group. RAATE-MCI is a 52-week randomized controlled trial. 144 African American adults aged 60 and older will be recruited.
Eligibility 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
Contact & Investigator
Robert L Newton, Jr., PhD
PRINCIPAL INVESTIGATOR
Pennington Biomedical Research
Frequently Asked Questions
Who can join the NCT04956549 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Dementia of Alzheimer Type. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04956549 currently recruiting?
Yes, NCT04956549 is actively recruiting participants. Contact the research team at callie.hebert@pbrc.edu for enrollment information.
Where is the NCT04956549 trial being conducted?
This trial is being conducted at Baton Rouge, United States.
Who is sponsoring the NCT04956549 clinical trial?
NCT04956549 is sponsored by Pennington Biomedical Research Center. The principal investigator is Robert L Newton, Jr., PhD at Pennington Biomedical Research. The trial plans to enroll 144 participants.
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