Clinical trial NCT04956549: Reducing African American's Alzheimer's Risk Through Exercise-Mild Cognitive Impairment (RAATE-MCI)
Official title: Reducing African Americans' Alzheimer's Disease Risk Through Exercise-Mild Cognitive Impairment Cohort
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dementia of Alzheimer Type
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2021-07-09
Enrollment: 144
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: Regular physical activity has proven to be a safe and effective means to enhance cognitive function in older adults ranging from cognitively healthy to mildly cognitively impaired. A large body of existing data suggests that exercise improves cardiovascular and cerebrovascular functioning and thus has the potential to enhance perivascular clearance of amyloid and reduce chronic brain tissue ischemia, among other beneficial effects. Therefore, our study is focused on physical activity promotion, a potent approach to modifying multiple neurobiological pathways implicated in Alzheimer's Disease. RAATE-MCI is a 52-week randomized controlled trial that will assign insufficiently active African American adults aged 60 and older to one of two groups: a physical activity intervention or a successful aging (active control) group. Outcome measures will be collected at baseline, 24-,and 52-weeks. 144 older African American adults will be recruited.

Intervention will consist of one of two groups: a 150 minutes of physical activity (PA) per week or successful aging (SA) group. All physical activity and successful aging group sessions will be conducted at Pennington Biomedical or at local community facilities that include branches of the YMCA and community centers.

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

Primary outcomes:
measure: Change in executive function
timeFrame: Baseline, 24 weeks, 52 weeks
measure: Change in episodic memory
timeFrame: Baseline, 24 weeks, 52 weeks
Secondary outcomes:
measure: Change in cognitive status
timeFrame: Baseline, 24 weeks, 52 weeks
measure: Change in glucose
timeFrame: Baseline, 24 weeks, 52 weeks
measure: Change in time spent in physical activity
timeFrame: Baseline, 24 weeks, 52 weeks
measure: Change in cardiorespiratory fitness
timeFrame: Baseline, 24 weeks, 52 weeks
measure: Change in physical function-NIH Toolbox
timeFrame: Baseline, 24 weeks, 52 weeks
measure: Change in telomere length
timeFrame: Baseline, 24 weeks, 52 weeks
measure: Change in weight
timeFrame: Baseline, 24 weeks, 52 weeks
measure: Change in brain structure
timeFrame: Baseline, 24 weeks, 52 weeks
measure: Changes in brain function
timeFrame: Baseline, 24 weeks, 52 weeks
measure: Change in lipoproteins
timeFrame: Baseline, 24 weeks, 52 weeks
measure: APOE genotype
timeFrame: Baseline
measure: Change in physical activity
timeFrame: Continuously for 52 weeks
measure: Change in systolic blood pressure
timeFrame: SV, 26 weeks, 52 weeks
measure: Change in diastolic blood pressure
timeFrame: SV, 26 weeks, 52 weeks
measure: Change in mood
timeFrame: Baseline, 24 weeks, 52 weeks
measure: Change in height
timeFrame: Baseline, 24 weeks, 52 weeks
measure: Change in physical function-SPPB
timeFrame: Baseline, 24 weeks, 52 weeks
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research
name: Robert L Newton, Jr., PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pennington Biomedical Research
name: Owen Carmichael, PhD
role: PRINCIPAL_INVESTIGATOR
References: