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New treatment option for Dementia of Alzheimer Type
Official title Reducing African American's Alzheimer's Risk Through Exercise-Mild Cognitive Impairment (RAATE-MCI)
ClinicalTrials.gov ID: NCT04956549
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 and older
You may be able to join if
- 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
You likely can't join if
- have cognitive impairment that would interfere with participating in a group discussion a. cognitive performance in the demented range (score \< 3...
- meet criteria for dementia
- 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
See the full eligibility criteria
- 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)
- 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...
- meet criteria for dementia
- 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
- 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...
- are undergoing cardiopulmonary rehabilitation
- have uncontrolled diabetes that in the judgment of the MI may interfere with study participation
- have clinically diagnosed osteoporosis that in the judgment of the MI may interfere with study participation
- are currently enrolled in another assigned by chance 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Baton Rouge, Louisiana, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baton Rouge, Louisiana, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.