Reducing African American's Alzheimer's Risk Through Exercise-Mild Cognitive Impairment (RAATE-MCI)

Not Applicable

Recruiting

• Conditions: Dementia of Alzheimer Type
• Interventions: Behavioral: Successful Aging; Behavioral: Physical activity program

• Registration Number: NCT04956549
• Lead Sponsor: Pennington Biomedical Research Center

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.

Study Timeline

• Study Start: 2021-06-01
• Study First Submitted: 2021-06-30
• Study First Submitted QC: 2021-06-30
• Study First Posted: 2021-07-09
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-12
• Last Update Posted: 2025-03-17
• Primary Completion: 2026-03-31
• Study Completion: 2027-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 144

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Successful Aging	Successful Aging	Low intensity activity program and a healthy aging educational component
Physical Activity	Physical activity program	150 minutes of physical activity weekly

Primary Outcome Measures

Name	Time	Method
Change in episodic memory	Baseline, 24 weeks, 52 weeks	The Rey Auditory Verbal Learning Test (RAVLT) is a common neuropsychological tool used to evaluate episodic memory. The RAVLT involves providing participants with 15 unrelated words and asking them to recall the word list. There are 5 trials designed to determine short-term memory and then a 30 minute delay to assess long-term memory. The total words correct in both the short- and long-term trials are used as outcome measures.
Change in executive function	Baseline, 24 weeks, 52 weeks	The primary outcome measure will be executive function measured by the NIH-Toolbox Cognitive Battery. The NIH Toolbox Executive Function subdomain consists of the Flanker Inhibitory Control and Attention Test and the Dimensional Change Card Sort Test. The Flanker test is a measure of one's ability to inhibit attention to irrelevant conditions. Participants must identify the direction of a central visual stimuli amongst flanking stimuli either congruent or incongruent with the central stimuli. There are 40 trials and scores range from 0 - 10. The Card Sort is a measure of the ability to shift attention based on rules. Participants must match a target visual stimuli to either a color or word stimuli and this matching shifts during the assessment.

Secondary Outcome Measures

Name	Time	Method
Change in physical activity	Continuously for 52 weeks	The Fitbit Charge 2 will be worn by participants in both groups.
Change in glucose	Baseline, 24 weeks, 52 weeks	Fasting levels of glucose will be assessed using standard assays.
Change in systolic blood pressure	SV, 26 weeks, 52 weeks	Systolic blood pressure will be measured using the Omron, Model BP710 automatic blood pressure cuff.
Change in height	Baseline, 24 weeks, 52 weeks	Height will be assessed using a standard stadiometer.
Change in physical function-SPPB	Baseline, 24 weeks, 52 weeks	Physical function will be assessed using the the Short Physical Performance Battery (SPPB), which is a brief performance battery based on timed short distance walk, repeated chair stands and balance test.
Change in physical function-NIH Toolbox	Baseline, 24 weeks, 52 weeks	Physical function will be assessed using the NIH-TB Motor assessment, which assesses dexterity, balance, locomotion, grip strength, and strength.
Change in weight	Baseline, 24 weeks, 52 weeks	Weight will be measured using a standard stadiometer. Measurements will be taken to the nearest cm.
Change in lipoproteins	Baseline, 24 weeks, 52 weeks	Fasting levels of lipids will be assessed using standard assays.
APOE genotype	Baseline	APOE genotype will be assessed using standard assays.
Change in brain structure	Baseline, 24 weeks, 52 weeks	Volumes of the cranial vault, brain tissue, gray matter, white matter, and cerebrospinal fluid, which will be provided as the primary brain structural outcome measures of interest from MRI.
Changes in brain function	Baseline, 24 weeks, 52 weeks	Pre-selected inhibitory control ROIs (ACC for the Stroop; DLPFC, thalamus, superior frontal, inferior frontal, fusiform, and middle frontal gyri; and ACC and middle frontal gyri for the ANT) are of primary interest.
Change in diastolic blood pressure	SV, 26 weeks, 52 weeks	Diastolic blood pressure (both systolic and diastolic) will be measured using the Omron, Model BP710 automatic blood pressure cuff.
Change in mood	Baseline, 24 weeks, 52 weeks	The Geriatric Depression Scale will be used to measure depressive symptoms.
Change in time spent in physical activity	Baseline, 24 weeks, 52 weeks	The Actigraph WGT3X+ accelerometer (ActiGraph LLC, Pensacola, FL) will be worn by the participant for a 7-day period. The device provides both the number of steps per day as well as time in sedentary, light, moderate, and vigorous activity in 1-minute epochs (for adults) using the default filter.
Change in cardiorespiratory fitness	Baseline, 24 weeks, 52 weeks	All participants will perform a standardized graded exercise testing protocol administered on a treadmill. Fitness will be measured in terms of mL oxygen/kg/min.
Change in telomere length	Baseline, 24 weeks, 52 weeks	DNA will be extracted from the blood draw and amplified using real-time quantitative polymerase chain reaction (qPCR) to determine average relative telomere length represented by the telomere repeat copy number to single gene copy number (T/S) ratio in triplicate as previously described
Change in cognitive status	Baseline, 24 weeks, 52 weeks	The Mini-Mental Status Examination is 30-point questionnaire to assess cognitive impairment.

Trial Locations

Locations (1)

Pennington Biomedical Research; 🇺🇸 Baton Rouge, Louisiana, United States