Exercise for Alzheimer's Disease

(RAATE Trial)

Overseen By Melissa Harris, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Pennington Biomedical Research Center

Disqualifiers: Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 52 weeks

125 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how physical activity affects Alzheimer's risk factors in older African American adults. It aims to determine if a tailored exercise program can improve memory and brain function related to Alzheimer's. Participants will either follow a moderate to vigorous exercise routine or engage in low-intensity activities with healthy aging education. Suitable candidates have not been regularly active, are African American, and have no conditions that make exercise unsafe. As an unphased trial, this study offers a unique opportunity to contribute to important research on Alzheimer's prevention in the community.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this physical activity intervention is safe for older African American adults?

Research has shown that physical activity benefits brain health and may lower the risk of Alzheimer's disease. Studies have found that regular exercise can reduce the chance of developing dementia by up to 20%. Those engaging in moderate to vigorous exercise face an even lower risk.

Exercise also boosts thinking skills, including awareness, perception, reasoning, and judgment. For older adults, staying active helps maintain these skills. Evidence suggests that exercise might also assist with daily tasks for those with Alzheimer's.

Regarding safety, physical activity is generally safe and does not involve surgery or entering the body. It lacks the side effects associated with medications. Most people can safely begin a regular exercise routine, but consulting a healthcare provider before starting any new program is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using physical activity as a treatment for Alzheimer's disease because it offers a non-pharmacological approach that could complement or even enhance existing treatments like cholinesterase inhibitors and NMDA receptor antagonists. Unlike medications that focus primarily on chemical interactions in the brain, this approach aims to improve cognitive function and overall health through increased blood flow and neuroplasticity resulting from aerobic and strength training exercises. This method also empowers patients to take an active role in their treatment by incorporating manageable lifestyle changes, potentially leading to improved quality of life and reduced symptoms without the side effects commonly associated with medications.

What evidence suggests that physical activity could be an effective treatment for Alzheimer's Disease?

Research has shown that physical activity can enhance brain function in people with Alzheimer's Disease. In this trial, participants in the physical activity intervention arm will engage in moderate to vigorous aerobic exercise and strength training. Previous studies suggest these activities might slow the decline in thinking skills for those with this condition. One study discovered that regular exercise could lower the risk of developing dementia by up to 20%. Engaging in moderate to vigorous physical activity may also lead to a 60% decrease in dementia risk. Overall, evidence suggests that staying active benefits brain health and may help manage Alzheimer's Disease. ^{2 3 6 7 8}

Who Is on the Research Team?

Robert L Newton, Jr., PhD

Principal Investigator

Pennington Biomedical Research Center

Owen Carmichael, PhD

Principal Investigator

Pennington Biomedical Research Center

Are You a Good Fit for This Trial?

The RAATE trial is for African American adults aged 60 and older who are not currently exercising regularly. Participants must be physically able to exercise, willing to attend group sessions, and have no plans to move during the study. They should not have cognitive impairments that interfere with group interactions or any medical conditions that make regular exercise unsafe.

Inclusion Criteria

You are able to do physical activity.

Lacking plans to move during the study period

My physical ability score is 4 or higher.

Exclusion Criteria

You have health issues that make it hard for you to exercise regularly.

Conditions that the medical or principal investigator determine to warrant exclusion

I do not have any cognitive issues that would prevent me from participating in group activities.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized into a physical activity promotion intervention or a healthy aging information group for 52 weeks

52 weeks

2 visits per week (in-person for supervised activity)

Follow-up

Participants are monitored for changes in cognitive function, brain structure, and other health parameters

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Physical activity
• Successful Aging

Trial Overview

This trial tests if a physical activity program can affect risk factors for Alzheimer's Disease in older African Americans. It compares this program against an active control group, focusing on changes in cognitive function, brain structure and function, as well as physiological parameters like blood pressure and fitness levels.

How Is the Trial Designed?

Group I: Physical activity intervention Experimental Treatment 1 Intervention

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.

Group II: Active control Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Pennington Biomedical Research Center

Lead Sponsor

Trials

314

Recruited

183,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

A 16-week supervised aerobic exercise program for 200 patients with mild Alzheimer's disease did not show significant improvements in overall cognitive performance or quality of life compared to a control group.

However, the exercise program significantly reduced neuropsychiatric symptoms and showed potential cognitive benefits in patients who adhered closely to the exercise regimen, indicating that regular, intense exercise may help improve certain aspects of cognitive function in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Moderate-to-High Intensity Physical Exercise in Patients with Alzheimer's Disease: A Randomized Controlled Trial. Hoffmann, K., Sobol, NA., Frederiksen, KS., et al.[2022]

A year-long exercise program for patients with Alzheimer's disease (AD) showed that those participating in group-based or home-based exercise experienced slower deterioration in physical functioning compared to a control group receiving usual care.

The exercise groups also had significantly fewer falls and did not incur higher costs for health and social services, suggesting that intense exercise can be a safe and effective intervention for improving mobility in AD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of the Finnish Alzheimer disease exercise trial (FINALEX): a randomized controlled trial. Pitkälä, KH., Pöysti, MM., Laakkonen, ML., et al.[2022]

A 12-week home-based physical activity program for 30 patients with Alzheimer's disease helped maintain their ability to perform daily activities, while the control group showed a decline in performance over the same period.

The intervention also led to improvements in cognitive functions, such as semantic word fluency and reaction time, and helped stabilize caregiver burden, suggesting that physical activity can be beneficial for both patients and their caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of physical activity training in patients with Alzheimer's dementia: results of a pilot RCT study. Holthoff, VA., Marschner, K., Scharf, M., et al.[2022]

In a study of 357 older adults who developed Alzheimer's disease (AD), those who engaged in physical activity (PA) prior to diagnosis had a lower risk of mortality during the follow-up period of about 5.2 years.

While PA did not influence the rate of cognitive or functional decline in AD patients, higher levels of PA were associated with prolonged survival, suggesting that exercise may positively impact the course of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity and Alzheimer disease course. Scarmeas, N., Luchsinger, JA., Brickman, AM., et al.[2021]

In a review of 63 articles from AARP magazines, only 3 English articles mentioned that physical activity (PA) could reduce the risk of Alzheimer's disease (AD), while no Spanish articles made this connection.

The study highlights a significant gap in cognitive health information in Spanish-language media, indicating a need for culturally relevant content to better inform diverse populations about the benefits of physical activity in relation to Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What are older Latinos told about physical activity and cognition? A content analysis of a top-circulating magazine. Rose, ID., Friedman, DB., Marquez, DX., et al.[2021]

Resistance exercise is the most effective form of exercise for slowing cognitive decline in Alzheimer's patients, with a 72.4% likelihood of benefiting overall cognitive function.

Multi-component exercise is particularly effective for improving executive function, while resistance exercise is the only type that significantly impacts memory function, which is less responsive to exercise overall.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of various exercise interventions on cognitive function in Alzheimer's patients: A network meta-analysis. Lv, S., Wang, Q., Liu, W., et al.[2023]

A review of 14 studies on exercise and Alzheimer's disease found that exercise can significantly improve daily functioning and performance in patients, enhancing their ability to carry out daily activities.

Exercise also positively impacts neuropsychiatric symptoms and various cognitive functions, including sustained attention and visual memory, suggesting it may be a valuable intervention for managing Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What are the Benefits of Exercise for Alzheimer's Disease? A Systematic Review of the Past 10 Years. Hernández, SS., Sandreschi, PF., da Silva, FC., et al.[2018]

In a study of 200 patients with mild Alzheimer's disease, those who carried the APOE ε4 genotype showed greater improvements in cognitive performance and physical measures from an exercise intervention.

The results suggest that the benefits of exercise in Alzheimer's patients may be influenced by their APOE genotype, indicating a potential avenue for personalized treatment strategies in managing Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients with Alzheimer's disease who carry the APOE ε4 allele benefit more from physical exercise. Jensen, CS., Simonsen, AH., Siersma, V., et al.[2022]

In a study of 91,298 older adults, vigorous physical activity (VPA) was found to significantly reduce Alzheimer's disease-related mortality, with optimal benefits observed at 140 minutes per week, potentially preventing up to 37,710 deaths annually in the U.S.

Moderate physical activity (MPA) did not show a significant association with Alzheimer's disease-related mortality, highlighting the greater importance of VPA for health outcomes in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Moderate and vigorous leisure time physical activity in older adults and Alzheimer's disease-related mortality in the USA: a dose-response, population-based study. López-Bueno, R., Yang, L., Stamatakis, E., et al.[2023]

Exercise can be an effective treatment for Alzheimer's disease (AD), showing improvements in cognitive function, reduced neuropsychiatric symptoms, and slower decline in daily activities, making it a valuable intervention alongside traditional medications.

Physical inactivity is a major preventable risk factor for developing AD, and higher levels of physical activity are linked to a lower risk of disease, highlighting the importance of exercise in both prevention and treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alzheimer's Disease and Exercise: A Literature Review. Cass, SP.[2017]

A meta-analysis of 29 studies with over 2 million participants found that physical activity significantly reduces the risk of developing Alzheimer's disease, with a hazard ratio of 0.72, indicating a 28% lower risk.

The protective effect of physical activity is strongest with moderate to vigorous intensity, showing a significant inverse relationship, while low-intensity activity did not demonstrate a protective effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of physical activity on risk of Alzheimer's disease: A systematic review and meta-analysis of twenty-nine prospective cohort studies. Zhang, X., Li, Q., Cong, W., et al.[2023]

Physical exercise may offer significant physical and mental benefits for individuals with Alzheimer's disease (AD), potentially addressing some of the metabolic and neuropathological changes associated with the condition.

The article reviews clinical studies that support the role of structured physical exercise programs in the treatment of AD, providing guidance on how to effectively prescribe these programs for older adults with dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits of physical exercise for older adults with Alzheimer's disease. Pérez, CA., Cancela Carral, JM.[2008]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11631704/

A meta-analysis of the efficacy of physical exercise ...

The results showed that physical exercise might significantly improve ADL in Alzheimer's patients (SMD = 0.33, 95% CI: 0.12–0.54, I2 = 81.7%).

2.

publichealth.jhu.edu

publichealth.jhu.edu/2025/small-amounts-of-moderate-to-vigorous-physical-activity-are-associated-with-big-reductions-in-dementia-risk

Small Amounts of Moderate to Vigorous Physical Activity Are ...

The researchers found dementia risk decreased with higher amounts of physical activity. Dementia risks were 60% lower in participants in the 35 ...

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S2274580724002693

Effectiveness of Physical Exercise on Alzheimer's disease. ...

This study suggests a walking-based PE program can stabilize and slow down the progressive cognitive dysfunctions exhibited by individuals with AD and improve ...

4.

alzheimers.org.uk

alzheimers.org.uk/about-dementia/managing-the-risk-of-dementia/reduce-your-risk-of-dementia/physical-activity

Physical activity and the risk of dementia

Research has shown that people who take regular exercise may be up to 20% less likely to develop dementia than those who don't take regular exercise.

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6130261/

Physical activity can improve cognition in patients with ...

This meta-analysis and systematic review indicated that exercise intervention might improve the cognitive function of AD or slow down the decline of cognition.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7498620/

Physical exercise in the prevention and treatment of ...

Low levels of physical activity are a risk factor associated with Alzheimer's disease. Older adults who exercise are more likely to maintain cognition.

7.

nih.gov

nih.gov/news-events/nih-research-matters/how-exercise-can-protect-against-alzheimers

How exercise can protect against Alzheimer's

Exercise has well-known protective effects in Alzheimer's disease (AD). More exercise is associated with lower risk of AD, better cognitive function, and less ...

8.

frontiersin.org

frontiersin.org/journals/public-health/articles/10.3389/fpubh.2024.1485807/full

A meta-analysis of the efficacy of physical exercise ...

The results showed that physical exercise might significantly improve ADL in Alzheimer's patients (SMD = 0.33, 95% CI: 0.12–0.54, I2 = 81.7%). Sensitivity ...