Lifestyle Intervention for Alzheimer's Disease

Overseen By Jesse N Cochran, PhD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: HudsonAlpha Institute for Biotechnology

Disqualifiers: Cognitive impairment, Pregnancy, Chronic disease, others

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

Compensation: Varies

Number of Visits: 4

Duration: 26 weeks

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if lifestyle changes can prevent or slow Alzheimer's in high-risk individuals who have not yet developed the disease. Researchers seek to understand perceptions of dementia risk and how best to use lifestyle changes to reduce it. The trial also examines factors that increase dementia risk and whether specific types of dementia are linked to genetic traits. Suitable participants have a family member with dementia and no current cognitive issues. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to improved prevention strategies for Alzheimer's.

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's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this multimodal lifestyle intervention is safe for individuals at high risk of dementia?

Research has shown that lifestyle changes focusing on diet, exercise, and mental activities have been studied for safety in people at risk of memory problems. One study found that these changes not only improved thinking skills but were also easy for participants to handle. Another study discovered that a structured lifestyle program targeting several risk factors improved thinking skills in older adults without causing significant side effects.

Overall, the research suggests that these lifestyle changes are safe and can help maintain brain health. No major reports of harmful side effects have emerged, making this approach a promising option for those looking to lower their risk of dementia. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the multimodal lifestyle intervention for Alzheimer's Disease because it takes a comprehensive approach to prevention, unlike traditional treatments that primarily focus on managing symptoms. This intervention targets a range of lifestyle factors, including diet, exercise, and cognitive engagement, which may help prevent or delay cognitive decline. By addressing multiple risk factors simultaneously, this method could offer a more holistic and proactive strategy in combating Alzheimer's, potentially reducing the risk before significant damage occurs.

What evidence suggests that this multimodal lifestyle intervention might be an effective treatment for Alzheimer's?

Research has shown that lifestyle changes in several areas can help slow memory and thinking problems. In this trial, individuals at high risk for cognitive impairment will receive a multimodal lifestyle intervention. Studies have found these lifestyle changes can be more effective than some medications in reducing the risk of Alzheimer's for those more likely to develop it. For example, one study found that older adults at risk improved their thinking skills by following a structured lifestyle plan. Another study showed that people with early memory and thinking issues or early Alzheimer's experienced improvements in both thinking and daily activities after 20 weeks. Overall, these lifestyle changes, including healthier eating, exercising, and staying socially active, seem to help delay the onset of dementia. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals at high risk of dementia or with Mild Cognitive Impairment (MCI), who have not yet been diagnosed with advanced dementia. It aims to assess and potentially reduce their risk factors through lifestyle changes.

Inclusion Criteria

Able and willing to provide the study's minimum samples

Able and willing to conduct the study's minimum procedures

Has or has ready access to a PC, tablet, or smartphone with an internet connection required for procedures that they consent to

Exclusion Criteria

I am not fluent in English.

I do not have severe hearing or vision problems that would stop me from participating in the study.

Any other vulnerable subject at the time of enrollment as specified above

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

22 weeks

1 visit (in-person)

Enrollment

Participants learn of their personalized dementia risk and possible lifestyle factors that may modify that risk

4 weeks

1 visit (in-person)

Treatment

High-risk participants receive a multimodal lifestyle intervention targeting the prevention of cognitive decline

26 weeks

Multiple visits (in-person and virtual)

Follow-up

Participants are monitored for changes in dementia risk factors and attitudes

26 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Multimodal Lifestyle Intervention

Trial Overview The study tests a Multimodal Lifestyle Intervention, which includes various lifestyle adjustments intended to delay the onset of Alzheimer's dementia in people at high risk or with MCI.

How Is the Trial Designed?

Group I: High risk for conversion to cognitive impairment Experimental Treatment 1 Intervention

This group will be defined by individuals who are high risk by our study-defined rubric taking family history, APOE genotype, AD PRS, mCAIDE score, lifestyle score described by Dhana and colleauges (see references section), MoCA, self-reported race/ethnicity, and pTau217 level into account. Individuals in this group will be offered a multimodal lifestyle intervention targeting the prevention of cognitive decline based on previous studies of lifestyle interventions for the prevention or delay of dementia as described in previous studies (see references section).

Group II: Not high risk for conversion to cognitive impairment Active Control 1 Intervention

This group will be defined by individuals who are not high risk by our study-defined rubric taking family history, Apolipoprotein E (APOE) genotype, Alzheimer's disease (AD) polygenic risk score (PRS), modified Cardiovascular Risk Factors, Aging and Incidence of Dementia (mCAIDE) score, lifestyle score described by Dhana and colleauges (see references section), Montreal Cognitive Assessment (MoCA), self-reported race/ethnicity, and pTau217 level into account.

Who Is Running the Clinical Trial?

HudsonAlpha Institute for Biotechnology

Lead Sponsor

Trials

3

Recruited

1,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37840487/

A Remotely Coached Multimodal Lifestyle Intervention for ... Conclusion: Multimodal lifestyle interventions are effective for ameliorating cognitive decline and have a larger effect size than pharmacological interventions ...

2. aaic.alz.org aaic.alz.org/releases-2025/us-pointer-study-results-announced.asp

U.S. POINTER Lifestyle Intervention Improved Cognition U.S. Pointer Study Shows Structured Lifestyle Program Targeting Multiple Risk Factors Improves Cognition in Older Adults at Risk of Cognitive ...

3. alzres.biomedcentral.com alzres.biomedcentral.com/articles/10.1186/s13195-024-01482-z

Effects of intensive lifestyle changes on the progression of ... Comprehensive lifestyle changes may significantly improve cognition and function after 20 weeks in many patients with MCI or early dementia due to AD.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2274580725003097

a systematic review of clinical trials combining multidomain ... The efficacy of EGCG in combination with multimodal intervention (dietary guidance, physical exercise, psychoeducation, social activities and ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT07146412

Study Details | NCT07146412 | Impact of a Multimodal ... Previous studies have shown that multimodal lifestyle interventions can significantly delay the onset of Alzheimer's dementia in individuals with high risk for ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11157928/

a randomized, controlled clinical trial - PMC - PubMed Central We report the first randomized, controlled trial showing that an intensive multimodal lifestyle intervention may significantly improve cognition ...

7. alzres.biomedcentral.com alzres.biomedcentral.com/articles/10.1186/s13195-024-01468-x

Integrating a multimodal lifestyle intervention with medical ... Our study shows that a complex multimodal lifestyle intervention with or without medical food is feasible in prodromal AD. Combining the ...