NCT04956549Recruiting
Reducing African American's Alzheimer's Risk Through Exercise-Mild Cognitive Impairment (RAATE-MCI)
Reducing African Americans' Alzheimer's Disease Risk Through Exercise-Mild Cognitive Impairment Cohort
Source: ClinicalTrials.gov · Last updated 17 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 144 (estimated)
- First submitted
- 30 Jun 2021
- Start date
- 1 Jun 2021
- Primary completion date
- 31 Mar 2026
- Lead sponsor
- Pennington Biomedical Research Center
- Diseases
- Alzheimer disease
- NCT number
- NCT04956549
What you commit to
- Study type: Interventional
- Planned participants: 144
- From 1 Jun 2021 to the primary completion date, 31 Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- meet criteria for dementia
- have uncontrolled hypertension (systolic blood pressure \> 150 mmHg and/or diastolic blood pressure \> 90 mmHg).
- 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
- have uncontrolled diabetes that in the judgment of the MI may interfere with study participation
- 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
Age
- have cognitive impairment that would interfere with participating in a group discussion
- 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)
Other
- are unwilling to give written informed consent or accept randomization in either study group
- are too active (as defined by ≥10 min bouts of MVPA as measured by Actigraph) if:
- Sum of MVPA bouts for the 7 day wear period ≥40 mins
- Or ≤40 mins of MVPA 10min bouts AND ≥3 days of bouts
- are undergoing cardiopulmonary rehabilitation
- have clinically diagnosed osteoporosis that in the judgment of the MI may interfere with study participation
- are currently enrolled in another randomized trial involving lifestyle or pharmaceutical interventions
- have another member of the household that is a participant in RAATE or RAATE MCI
- refuse to participate in the study without disclosure of their amyloid PET scan results
- refuse to allow anonymized versions of their study data for research after this study is completed.
Who the study is looking for
- are African American (self-identify)
- are 60 and older
- are physically capable of exercise
- are willing to accept randomization
- are willing to attend group sessions
- 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
- 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
- have not engaged in regular physical activity
- have a Short Physical Performance Battery ≥4
- physically capable of exercise
- are unable to utilize devices and/or applications as required for study participation
- willing to attend group sessions
- willing to allow researchers to use data for research purposes after study participation is completed
- 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)
Age in the registry: 60 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pennington Biomedical Research Coordinator of this site? Confirm its status | Baton Rouge | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.