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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 below
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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:
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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 weeks
Treatment ~ Varies
Follow Up ~sv, 26 weeks, 52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and sv, 26 weeks, 52 weeks for reporting.

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 more

Awards & 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

Find a Location

Who is running the clinical trial?

Pennington Biomedical Research CenterLead Sponsor
309 Previous Clinical Trials
179,774 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,802 Previous Clinical Trials
28,193,837 Total Patients Enrolled
Robert L Newton, Jr., PhDPrincipal InvestigatorPennington Biomedical Research
2 Previous Clinical Trials
222 Total Patients Enrolled
Robert Newton, Jr., PhDPrincipal InvestigatorPennington Biomedical Research
Owen Carmichael, PhDPrincipal InvestigatorPennington Biomedical Research

Media Library

Physical activity program Clinical Trial Eligibility Overview. Trial Name: NCT04956549 — N/A
Alzheimer's Dementia Research Study Groups: Physical Activity, Successful Aging
Alzheimer's Dementia Clinical Trial 2023: Physical activity program Highlights & Side Effects. Trial Name: NCT04956549 — N/A
Physical activity program 2023 Treatment Timeline for Medical Study. Trial Name: NCT04956549 — N/A
~20 spots leftby Aug 2025