Dementia of Alzheimer TypeRAATE-MCINCT04956549
Reducing African American's Alzheimer's Risk Through Exercise-Mild Cognitive Impairment (RAATE-MCI)
A study testing Physical activity program and Successful Aging in people with Dementia of Alzheimer Type, run by Pennington Biomedical Research Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Dementia of Alzheimer Type
- What is being tested?
- Physical activity program and Successful Aging
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2021to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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)
- 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
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- 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 months
- 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 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.
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Pennington Biomedical Research
Baton Rouge, Louisiana, 70808
Jenny Ricks, MA, 225-763-0939, jenny.ricks@pbrc.edu
Callie Hebert, MS, 225-763-2632, callie.hebert@pbrc.edu
About this study
Official title: Reducing African Americans' Alzheimer's Disease Risk Through Exercise-Mild Cognitive Impairment Cohort
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.
Read the 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.
- Conditions
- Dementia of Alzheimer Type
- Being tested
- Physical activity program, Successful Aging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity programBehavioural
Supervised group sessions will be held twice per week for approximately 52 weeks. Each physical activity session will last slightly approximately 80 minutes and will consist of aerobic, strength, flexibility, and balance training. The 80 minutes of activity consists of a 5 minute warm-up, 45 minutes of aerobic training, 15 minutes of strength training, 10 minutes of balance training, and a 5 minute cool-down. The physical activity group will target 150 minutes of moderate to vigorous aerobic physical activity and two days of strength training, consistent with the current physical activity recommendations.
Successful AgingBehavioural
Also called active control
The successful aging group will be based on a low-intensity activity program and a healthy aging educational component. Sessions will be approximately 60 minutes in duration and will occur once per week for the first 6 months and then every other week for the remainder 6 months of the study. The physical activities will include stretching, balance training, flexibility, relaxation, and practicing activities of daily living. The successful aging education component will cover topics including avoiding scams, fall prevention, living wills, and dementia awareness.
| Study group | Role | What they receive |
|---|---|---|
| Physical Activity | Experimental | 150 minutes of physical activity weekly Receives: Behavioral: Physical activity program |
| Successful Aging | Experimental | Low intensity activity program and a healthy aging educational component Receives: Behavioral: Successful Aging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in executive function
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.
Measured: Baseline, 24 weeks, 52 weeks
Change in episodic memory
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.
Measured: Baseline, 24 weeks, 52 weeks
Secondary outcomes (17)
Change in cognitive status
The Mini-Mental Status Examination is 30-point questionnaire to assess cognitive impairment.
Measured: Baseline, 24 weeks, 52 weeks
Change in glucose
Fasting levels of glucose will be assessed using standard assays.
Measured: Baseline, 24 weeks, 52 weeks
Change in time spent in physical activity
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.
Measured: Baseline, 24 weeks, 52 weeks
Change in cardiorespiratory fitness
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.
Measured: Baseline, 24 weeks, 52 weeks
Change in physical function-NIH Toolbox
Physical function will be assessed using the NIH-TB Motor assessment, which assesses dexterity, balance, locomotion, grip strength, and strength.
Measured: Baseline, 24 weeks, 52 weeks
Change in telomere length
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
Measured: Baseline, 24 weeks, 52 weeks
Change in weight
Weight will be measured using a standard stadiometer. Measurements will be taken to the nearest cm.
Measured: Baseline, 24 weeks, 52 weeks
Change in brain structure
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.
Measured: Baseline, 24 weeks, 52 weeks
Changes in brain function
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.
Measured: Baseline, 24 weeks, 52 weeks
Change in lipoproteins
Fasting levels of lipids will be assessed using standard assays.
Measured: Baseline, 24 weeks, 52 weeks
APOE genotype
APOE genotype will be assessed using standard assays.
Measured: Baseline
Change in physical activity
The Fitbit Charge 2 will be worn by participants in both groups.
Measured: Continuously for 52 weeks
Change in systolic blood pressure
Systolic blood pressure will be measured using the Omron, Model BP710 automatic blood pressure cuff.
Measured: SV, 26 weeks, 52 weeks
Change in diastolic blood pressure
Diastolic blood pressure (both systolic and diastolic) will be measured using the Omron, Model BP710 automatic blood pressure cuff.
Measured: SV, 26 weeks, 52 weeks
Change in mood
The Geriatric Depression Scale will be used to measure depressive symptoms.
Measured: Baseline, 24 weeks, 52 weeks
Change in height
Height will be assessed using a standard stadiometer.
Measured: Baseline, 24 weeks, 52 weeks
Change in physical function-SPPB
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.
Measured: Baseline, 24 weeks, 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2021
- Study start1 Jun 2021
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dementia of Alzheimer TypeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Robert L. Newton, Jr., Pennington Biomedical Research Center
- Investigators
- Robert L Newton, Jr., PhD, Principal investigator, Pennington Biomedical ResearchOwen Carmichael, PhD, Principal investigator, Pennington Biomedical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04956549
- Sponsor's protocol ID
- PBRC 2020-013
- Other IDs
- R01AG067765-01
- Acronym
- RAATE-MCI
- Status last verified
- Mar 2025
- First submitted
- 30 Jun 2021
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: For all study data, Pennington Biomedical has a well-structured internal process for data sharing and transfer. The Office of Legal and Regulatory Compliance is responsible for all data agreements which includes data subject to the protection under HIPAA. As part of the Louisiana State University System, Pennington Biomedical ensures that data agreements are in place in the following circumstances: business associate agreements when the transfer of data contains all identifiers, data use agreements when the transfer of data contains those identifiers that constitute a limited data set and a data transfer agreement in instances where data is de-identified, but still may be subject of protection in order to protect intellectual property rights. Transmission of data to ensure proper safeguards are in place on the data in motion and data at reset are carried out with assistance of the Research Computing Group or the Office of Computing Services.
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing African Americans' Alzheimer's Disease Risk Through Exercise-Mild Cognitive Impairment Cohort
- ClinicalTrials.gov ID
- NCT04956549
- Acronym / sponsor ID
- RAATE-MCI / PBRC 2020-013
- Conditions
- Dementia of Alzheimer Type
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 9 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Activity | Experimental | Behavioral: Physical activity program150 minutes of physical activity weekly |
| Successful Aging | Experimental | Behavioral: Successful AgingLow intensity activity program and a healthy aging educational component |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (17 listed)
- have cognitive impairment that would interfere with participating in a group discussion
- 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:
- have uncontrolled hypertension (systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 90 mmHg).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity programSupervised group sessions will be held twice per week for approximately 52 weeks. Each physical activity session will last slightly approximately 80 minutes and will consist of aerobic, strength, flexibility, and balance training. The 80 minutes of activity consists of a 5 minute warm-up, 45 minutes of aerobic training, 15 minutes of strength training, 10 minutes of balance training, and a 5 minute cool-down. The physical activity group will target 150 minutes of moderate to vigorous aerobic physical activity and two days of strength training, consistent with the current physical activity recommendations. | Behavioural | Physical Activity |
| Successful AgingAlso: active controlThe successful aging group will be based on a low-intensity activity program and a healthy aging educational component. Sessions will be approximately 60 minutes in duration and will occur once per week for the first 6 months and then every other week for the remainder 6 months of the study. The physical activities will include stretching, balance training, flexibility, relaxation, and practicing activities of daily living. The successful aging education component will cover topics including avoiding scams, fall prevention, living wills, and dementia awareness. | Behavioural | Successful Aging |
Primary outcome
Change in executive function
Time frame: 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.
Change in episodic memory
Time frame: 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.
17 secondary outcomes
Change in cognitive status
Time frame: Baseline, 24 weeks, 52 weeks
Change in glucose
Time frame: Baseline, 24 weeks, 52 weeks
Change in time spent in physical activity
Time frame: Baseline, 24 weeks, 52 weeks
Change in cardiorespiratory fitness
Time frame: Baseline, 24 weeks, 52 weeks
Change in physical function-NIH Toolbox
Time frame: Baseline, 24 weeks, 52 weeks
Change in telomere length
Time frame: Baseline, 24 weeks, 52 weeks
Change in weight
Time frame: Baseline, 24 weeks, 52 weeks
Change in brain structure
Time frame: Baseline, 24 weeks, 52 weeks
Changes in brain function
Time frame: Baseline, 24 weeks, 52 weeks
Change in lipoproteins
Time frame: Baseline, 24 weeks, 52 weeks
APOE genotype
Time frame: Baseline
Change in physical activity
Time frame: Continuously for 52 weeks
Change in systolic blood pressure
Time frame: SV, 26 weeks, 52 weeks
Change in diastolic blood pressure
Time frame: SV, 26 weeks, 52 weeks
Change in mood
Time frame: Baseline, 24 weeks, 52 weeks
Change in height
Time frame: Baseline, 24 weeks, 52 weeks
Change in physical function-SPPB
Time frame: Baseline, 24 weeks, 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Individual participant dataSharing planned: Yes. For all study data, Pennington Biomedical has a well-structured internal process for data sharing and transfer. The Office of Legal and Regulatory Compliance is responsible for all data agreements which includes data subject to the protection under HIPAA. As part of the Louisiana State University System, Pennington Biomedical ensures that data agreements are in place in the following circumstances: business associate agreements when the transfer of data contains all identifiers, data use agreements when the transfer of data contains those identifiers that constitute a limited data set and a data transfer agreement in instances where data is de-identified, but still may be subject of protection in order to protect intellectual property rights. Transmission of data to ensure proper safeguards are in place on the data in motion and data at reset are carried out with assistance of the Research Computing Group or the Office of Computing Services.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert L Newton, Jr., PhD principal investigator
Pennington Biomedical Research
Owen Carmichael, PhD principal investigator
Pennington Biomedical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity program and Successful Aging in people with Dementia of Alzheimer Type, run by Pennington Biomedical Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Callie Hebert, MS (225-763-2362, callie.hebert@pbrc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in executive function (time frame: Baseline, 24 weeks, 52 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025.