Exercise to Reduce Alzheimer's Risk in Older African Americans

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The RAATE-MCI initiative aims to investigate the impact of physical activity on Alzheimer's disease risk factors among older African American adults. This 52-week randomized controlled trial will compare a structured physical activity program with an active control group focused on successful aging. A total of 144 participants aged 60 and older will be recruited, and outcomes will be assessed at baseline, 24 weeks, and 52 weeks. The study seeks to enhance cognitive function and modify neurobiological pathways associated with Alzheimer's through regular exercise.

Why it matters

Who can join: the full rules

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

Where it's running

• Pennington Biomedical Research
  Baton Rouge, Louisiana, United States Recruiting

Study contacts

• Principal investigator: Robert L Newton, Jr., PhD — Pennington Biomedical Research
• Study coordinator: Callie Hebert, MS
• Email: callie.hebert@pbrc.edu
• Phone: 225-763-2362

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Comparing autonomic function in patients with cognitive decline

  This study is testing how well a device can measure the automatic functions of the body in people aged 50 to 85 who have mild cognitive decline, like mild dementia or Alzheimer's, to better understand their condition.

  Recruiting Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Rome, Lazio · NCT06292741

• Project to identify cognitive impairment and dementia risk using mobility tests

  This study is testing a new way to spot early signs of cognitive problems and dementia by combining a mobility test with a verbal task to see if it can help identify those at risk.

  Recruiting Dalarna University · Falun, Dalarna County and 1 other locations · NCT05893524

• Measuring brain fibrin levels in Alzheimer's disease

  This study is testing a new imaging technique to see how levels of a protein called fibrin in the brain differ among people with Alzheimer's disease and those with normal thinking skills.

  Recruiting Phase 1/2 Massachusetts General Hospital · Boston, Massachusetts · NCT05336695

• Understanding Hearing Aid Outcomes in Older Adults with Alzheimer's Dementia

  This study is testing how different hearing aid settings can help older adults with Alzheimer's dementia and memory issues understand speech better and have more successful conversations.

  Recruiting at 2 sites Northwestern University · Chicago, Illinois and 1 other locations · NCT04240561

• Aging Brain Health Initiative in Fujian

  This observational study will follow about 3,000 older adults in Fujian to see how Alzheimer's-related changes develop and to test new digital tests, biomarkers, and imaging tools for early diagnosis.

  Recruiting at 4 sites Fujian Medical University Union Hospital · Fushun, Fujian and 3 other locations · NCT07891429

• Restoring Cervical Lymphatic Drainage in Alzheimer’s Disease

  A small study tests whether a minimally invasive surgery to improve cervical lymphatic drainage can affect biomarkers, brain imaging, and cognition in people with Alzheimer's who can’t access other disease-modifying therapies.

  Recruiting University of Siena · Siena, Tuscany · NCT07854327

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.