Dementia, Alzheimer TypeRAATENCT03890861
Reducing African Americans' Alzheimer's Disease Risk Through Exercise (RAATE)"
A study testing Physical activity and Successful Aging in people with Dementia, Alzheimer Type, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
The RAATE 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia, Alzheimer Type
- What is being tested?
- Physical activity and Successful Aging
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Aug 2019to Nov 2026
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- self- identify as African American
- 60 years and older
- willing to accept randomization
- willing to attend group sessions
- lacking plans to move during the study period
- free of conditions that would make regular exercise unsafe (e.g. uncontrolled asthma, severe sickle cell disease, etc.)
Show all 9Show fewer
- not engaged in regular physical activity
- Short Physical Performance Battery score >/= 4
- physically capable of exercise,
Who cannot join
- cognitive impairment that would interfere with participating in group interactions
- unwilling to give written informed consent
- inability to attend group sessions
- conditions that prevent regular exercise
- conditions that the medical or principal investigator determine to warrant exclusion
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 Center
Baton Rouge, Louisiana, 70808
Melissa Harris, MA, 2257633091, Melissa.Harris@pbrc.edu
Jessica St. Romain, MA, 2257632921, Jessica.Stromain@pbrc.edu
About this study
The RAATE 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. There are three main objectives of the protocol: 1) to determine if a physical activity intervention tailored to older African American adults is effective in modifying cognitive function associated with Alzheimer's Disease, 2) to determine if a physical activity intervention tailored to older African American adults is effective in modifying brain function and structure associated with Alzheimer's Disease, and 3) to determine if a physical activity promotion intervention tailored to African American adults is effective at enhancing physiological parameters. The primary endpoints for the study are episodic memory and executive functioning. The secondary outcomes include anthropometry, blood pressure, brain activation, cerebral blood flow, volume of whole brain and white matter hyperintensities, cardiorespiratory fitness, objectively measured physical activity, circulating hormones, and telomere length.
Read the detailed description
Alzheimer's disease is steadily increasing in prevalence, with a devastating public health impact. The prevalence of Alzheimer's Disease is higher in African Americans compared to white Americans, thereby constituting a health disparity. Interventions that prevent Alzheimer's disease or change the course of cognitive decline associated with Alzheimer's disease are needed. Most older adults do not achieve recommended levels of physical activity, and this includes African Americans. 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. Therefore, our study is focused on physical activity promotion, a potent approach to modifying multiple neurobiological pathways implicated in Alzheimer's Disease. We evaluate exercise benefits among elderly African Americans, who are understudied and in whom the natural course of neurodegeneration, exercise effects on neuroprotection and neurodegeneration, and resulting clinical phenotypes may differ. 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. At the same time, chronic exercise has been shown to decrease central levels of inflammatory markers and increase central levels of neurotrophic factors, which in turn promote protection against Alzheimer's Disease neurodegeneration pathways via a variety of mechanisms. While physical activity interventions have been shown to have positive effects on these factors and on resultant cognitive functioning in older adults, nearly all interventions have had a negligible representation of African Americans. Prior data suggests that African Americans enter their elderly years against a backdrop of different lifespan exposures to a variety of factors relevant to neuroprotection and neurodegeneration, including cardiovascular risk, exercise, diet, and education. In addition, prior data suggests that the key genetic risk factor for Alzheimer's Disease (APOE) may have differing consequences for Alzheimer's Disease risk among African Americans, and other genetic differences have the potential to influence the brain benefits of physical activity in this community. We will utilize a randomized clinical trial to addresses these questions. Participants will be randomized into a physical activity promotion intervention or a healthy aging information group for 52 weeks. All participants will be of normal cognitive function. We will assess cognitive function, brain structure and function, circulating hormones, objectively measured physical activity, cardiorespiratory fitness, and telomere length. Our study will take the first step toward understanding whether the hypothesized benefits of exercise for the brain carry over to elderly African Americans.
- Conditions
- Dementia, Alzheimer Type
- Being tested
- Physical activity, Successful Aging
- Keywords
- African American, Aging, Physical activity, Cognition, Prevention
- Medical subject headings
- Alzheimer Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activityBehavioural
Promotion of physical activity to the current federal physical activity guidelines.
Successful AgingBehavioural
Seminars of health topics related to aging in African Americans with light stretching and low intensity activites
| Study group | Role | What they receive |
|---|---|---|
| Physical activity intervention | Experimental | The intervention 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. Participants will engage in 2 days per week of supervised activity at community facilities. These participants will be requested to engage in an additional 30 minutes of moderate to vigorous aerobic physical activity two days per week at home. Receives: Behavioral: Physical activity |
| Active control | Active comparator | The active control group will be based on a low-intensity activity program and a healthy aging educational component. 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. Receives: Behavioral: Successful Aging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Change in executive function
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
Secondary outcomes (16)
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 blood pressure
Blood pressure will be measured using the Omron, Model BP710 automatic blood pressure cuff.
Measured: Blood pressure will be measured using the Omron, Model BP710 automatic blood pressure cuff.
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 posted26 Mar 2019
- Study start9 Aug 2019
- Primary completionNov 2025 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dementia, 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
- 125 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 Research CenterOwen L Carmichael, PhD, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03890861
- Sponsor's protocol ID
- PBRC 2019-002
- Other IDs
- R01AG062200-01
- Acronym
- RAATE
- Status last verified
- Nov 2024
- First submitted
- 18 Mar 2019
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing African Americans' Alzheimer's Disease Risk Through Exercise (RAATE)"
- ClinicalTrials.gov ID
- NCT03890861
- Acronym / sponsor ID
- RAATE / PBRC 2019-002
- Conditions
- Dementia, Alzheimer Type
- Keywords
- African American, Aging, Physical activity, Cognition, Prevention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 9 Aug 2019 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 26 Mar 2019 (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 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. There are three main objectives of the protocol: 1) to determine if a physical activity intervention tailored to older African American adults is effective in modifying cognitive function associated with Alzheimer's Disease, 2) to determine if a physical activity intervention tailored to older African American adults is effective in modifying brain function and structure associated with Alzheimer's Disease, and 3) to determine if a physical activity promotion intervention tailored to African American adults is effective at enhancing physiological parameters. The primary endpoints for the study are episodic memory and executive functioning. The secondary outcomes include anthropometry, blood pressure, brain activation, cerebral blood flow, volume of whole brain and white matter hyperintensities, cardiorespiratory fitness, objectively measured physical activity, circulating hormones, and telomere length.
Detailed description
Alzheimer's disease is steadily increasing in prevalence, with a devastating public health impact. The prevalence of Alzheimer's Disease is higher in African Americans compared to white Americans, thereby constituting a health disparity. Interventions that prevent Alzheimer's disease or change the course of cognitive decline associated with Alzheimer's disease are needed. Most older adults do not achieve recommended levels of physical activity, and this includes African Americans. 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. Therefore, our study is focused on physical activity promotion, a potent approach to modifying multiple neurobiological pathways implicated in Alzheimer's Disease. We evaluate exercise benefits among elderly African Americans, who are understudied and in whom the natural course of neurodegeneration, exercise effects on neuroprotection and neurodegeneration, and resulting clinical phenotypes may differ. 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. At the same time, chronic exercise has been shown to decrease central levels of inflammatory markers and increase central levels of neurotrophic factors, which in turn promote protection against Alzheimer's Disease neurodegeneration pathways via a variety of mechanisms. While physical activity interventions have been shown to have positive effects on these factors and on resultant cognitive functioning in older adults, nearly all interventions have had a negligible representation of African Americans. Prior data suggests that African Americans enter their elderly years against a backdrop of different lifespan exposures to a variety of factors relevant to neuroprotection and neurodegeneration, including cardiovascular risk, exercise, diet, and education. In addition, prior data suggests that the key genetic risk factor for Alzheimer's Disease (APOE) may have differing consequences for Alzheimer's Disease risk among African Americans, and other genetic differences have the potential to influence the brain benefits of physical activity in this community. We will utilize a randomized clinical trial to addresses these questions. Participants will be randomized into a physical activity promotion intervention or a healthy aging information group for 52 weeks. All participants will be of normal cognitive function. We will assess cognitive function, brain structure and function, circulating hormones, objectively measured physical activity, cardiorespiratory fitness, and telomere length. Our study will take the first step toward understanding whether the hypothesized benefits of exercise for the brain carry over to elderly African Americans.
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 intervention | Experimental | Behavioral: Physical activityThe intervention 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. Participants will engage in 2 days per week of supervised activity at community facilities. These participants will be requested to engage in an additional 30 minutes of moderate to vigorous aerobic physical activity two days per week at home. |
| Active control | Active comparator | Behavioral: Successful AgingThe active control group will be based on a low-intensity activity program and a healthy aging educational component. 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- self- identify as African American
- 60 years and older
- willing to accept randomization
- willing to attend group sessions
- lacking plans to move during the study period
Key exclusion criteria (5 listed)
- cognitive impairment that would interfere with participating in group interactions
- unwilling to give written informed consent
- inability to attend group sessions
- conditions that prevent regular exercise
- conditions that the medical or principal investigator determine to warrant exclusion
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 activityPromotion of physical activity to the current federal physical activity guidelines. | Behavioural | Physical activity intervention |
| Successful AgingSeminars of health topics related to aging in African Americans with light stretching and low intensity activites | Behavioural | Active control |
Primary outcome
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.
Change in executive function
Time frame: Baseline, 24 weeks, 52 weeks
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.
16 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 blood pressure
Time frame: Blood pressure will be measured using the Omron, Model BP710 automatic blood pressure cuff.
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 25 Nov 2024.
- 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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Agitation
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 Center
Owen L Carmichael, PhD principal investigator
Pennington Biomedical Research Center
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 and Successful Aging in people with Dementia, 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 9 inclusion and 5 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 25 Nov 2024. 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 Melissa Harris, PhD (225763091, Melissa.Harris@pbrc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in episodic memory (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 25 Nov 2024.