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Physical Activity for Alzheimer's Disease (RAATE-MCI Trial)
N/A
Recruiting
Led By Robert L Newton, Jr., PhD
Research Sponsored by Pennington Biomedical Research Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have a Short Physical Performance Battery score ≥4
Aged 60 and older
Must not have
Unwilling to give written informed consent or accept randomization in either study group
Undergoing cardiopulmonary rehabilitation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights
No Placebo-Only Group
Summary
This trial will compare the effects of physical activity on risk factors for Alzheimer's Disease in older African American adults.
Who is the study for?
The RAATE-MCI trial is for African American adults aged 60 or older who self-identify as such, are willing to be randomly assigned to groups, can attend sessions and travel within the study area for a year. They must be physically able to exercise but not currently active, have mild cognitive impairment without severe dementia, and agree to data use after the study.
What is being tested?
This trial tests if physical activity affects Alzheimer's risk factors in older African Americans. Participants will either join a physical activity program or an active control group for one year. The goal is to see how exercise influences cognitive health compared with usual activities.
What are the potential side effects?
Since this trial involves a physical activity program, potential side effects may include typical exercise-related risks like muscle soreness, strains or sprains. However, participants deemed at risk for serious exercise-related issues by medical staff won't be included.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My physical ability score is 4 or higher.
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I am 60 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not willing to sign consent or be randomly assigned to a study group.
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I am currently in a heart and lung rehab program.
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My diabetes is not under control.
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I have difficulty thinking or remembering that would make it hard for me to join in a group talk.
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I have been diagnosed with osteoporosis.
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My high blood pressure is not under control.
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I am not part of another trial that involves lifestyle or drug treatments.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ sv, 26 weeks, 52 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~sv, 26 weeks, 52 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in episodic memory
Change in executive function
Secondary study objectives
APOE genotype
Change in brain structure
Change in cardiorespiratory fitness
+14 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Successful AgingExperimental Treatment1 Intervention
Low intensity activity program and a healthy aging educational component
Group II: Physical ActivityExperimental Treatment1 Intervention
150 minutes of physical activity weekly
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Successful Aging
2019
Completed Phase 3
~1720
Physical activity program
2007
N/A
~320
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Who is running the clinical trial?
Pennington Biomedical Research CenterLead Sponsor
309 Previous Clinical Trials
179,988 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,789 Previous Clinical Trials
28,188,188 Total Patients Enrolled
Robert L Newton, Jr., PhDPrincipal InvestigatorPennington Biomedical Research
2 Previous Clinical Trials
222 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not willing to sign consent or be randomly assigned to a study group.I am currently in a heart and lung rehab program.My diabetes is not under control.I plan to stay in the study area and can travel to the clinic for a year.I have difficulty thinking or remembering that would make it hard for me to join in a group talk.I have been diagnosed with osteoporosis.My high blood pressure is not under control.I am not part of another trial that involves lifestyle or drug treatments.I have not had certain medical conditions in the last 6 months.I am willing to participate in group sessions.My physical ability score is 4 or higher.I am 60 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Physical Activity
- Group 2: Successful Aging
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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