Lifestyle Intervention with Coaching for Cognitive Impairment

(PREVENTION Trial)

Overseen By Jennifer Bramen, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: John Wayne Cancer Institute

Disqualifiers: Non-AD neurodegenerative disorders, Cerebrovascular disease, AD high-risk mutation, MMSE below 20, CDR score 2 or above

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a lifestyle intervention for individuals with memory and thinking problems, often linked to mild Alzheimer's or cognitive decline. Participants will be divided into two groups: one will receive personalized health advice (Data-Driven Clinical Recommendations), while the other will receive the same advice plus additional support, including coaching and exercise classes (Coached Data-Driven Clinical Recommendations). The goal is to determine if these strategies can enhance memory, daily functioning, and quality of life. Suitable candidates have experienced memory issues and have a positive amyloid PET scan, indicating Alzheimer's-related brain changes. Participants should be comfortable using computers and speaking with a coach by phone.

As an unphased trial, this study provides a unique opportunity to advance understanding of lifestyle interventions for cognitive health.

Do I have to stop taking my current medications to join the trial?

The trial does not require you to stop taking your current medications as long as your medical conditions are stable and you haven't started any new medications for chronic conditions in the last three months.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that lifestyle changes like those in this trial are generally safe and well-tolerated. Other studies have found that similar changes can improve brain function in older adults. For example, the U.S. POINTER study demonstrated better thinking skills without major side effects.

In this trial, participants will receive health coaching, dietary advice, and engage in physical and mental exercises. These activities are typically low-risk and aim to boost overall health. So far, studies have not reported serious side effects from these types of activities.

This trial does not involve testing new drugs, which usually means fewer risks. However, participants should consult their doctor about any concerns to ensure this trial suits their health needs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Lifestyle Intervention with Coaching for Cognitive Impairment trial because it explores innovative ways to manage cognitive decline that go beyond standard medications and therapies. Unlike traditional treatments that often focus solely on medication, this trial uses data-driven coaching to tailor lifestyle changes specifically for each individual. The approach includes a multi-modal intervention, meaning it combines various strategies like diet, exercise, and cognitive exercises, all guided by a coach. This personalized and holistic method has the potential to not only slow cognitive decline but also improve overall quality of life, making it a promising direction for future treatment options.

What evidence suggests that this trial's treatments could be effective for cognitive decline?

This trial will compare two approaches: Group 1 will receive data-driven clinical recommendations (CR), while Group 2 will receive a data-driven coached multi-modal intervention (MMIC). Research has shown that a lifestyle program with coaching can improve thinking and memory. In past studies, such as the COCOA trial, participants who received coaching based on personal data experienced slower memory loss. These programs often include personalized assistance, dietary advice, and exercise, all beneficial for brain health. The MyCOACH trial also found that short-term programs for memory problems enhanced thinking and memory skills. This suggests that combining different methods with coaching can benefit individuals with memory issues, including mild Alzheimer's and memory loss. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

Adults aged 50-80 with mild Alzheimer's Disease, mild cognitive impairment, or subjective memory complaints are eligible. They must be proficient in English, stable on medications for chronic conditions, able to use a computer and the Internet, and willing to undergo an amyloid PET scan showing evidence of AD pathology.

Inclusion Criteria

My gender, race, or ethnicity does not limit my participation.

Subjects, with or without assistance, must be able to use a computer and web interface. If assistance is needed, it must be readily available to them.

I have a caregiver or legal representative to accompany me for my treatments.

Exclusion Criteria

You have a high score on a test for dementia.

I or my immediate family have a high-risk gene mutation for Alzheimer's.

I have been diagnosed with a neurodegenerative disorder that is not Alzheimer's.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized into two groups: Group 1 receives data-driven clinical recommendations, and Group 2 receives a multi-modal intervention with coaching.

12 months

Regular visits for coaching and assessments

Follow-up

Participants are monitored for changes in cognitive and functional abilities, quality of life, and biological measures after treatment.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Coached Data-Driven Clinical Recommendations
• Data-Driven Clinical Recommendations

Trial Overview The trial tests two approaches over 12 months: one group receives data-driven clinical recommendations (Active Control), while the other gets these plus a coached multi-modal lifestyle intervention including health coaching sessions, dietary counseling, exercise classes (CogFit), and at-home neurocognitive programs.

How Is the Trial Designed?

Group I: Group 2 - Data-driven coached multi-modal intervention (MMIC) Experimental Treatment 1 Intervention

Data-driven coached multi-modal intervention (MMIC)

Group II: Group 1 - Data-driven clinical recommendations (CR) Active Control 1 Intervention

Data-driven clinical recommendations (CR)

Who Is Running the Clinical Trial?

John Wayne Cancer Institute

Lead Sponsor

Trials

22

Recruited

5,500+

Saint John's Cancer Institute

Lead Sponsor

Trials

27

Recruited

6,800+

Institute for Systems Biology

Collaborator

Institute for Systems Biology

Collaborator

Trials

4

Recruited

330+

St. Joseph's Healthcare Foundation

Collaborator

Trials

6

Recruited

380+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04082611

Study Details | NCT04082611 | The PREVENTION Trial ... The first objective is to evaluate the efficacy of a coached, data-driven, multi-modal lifestyle intervention to treat cognitive decline. Subjects will be ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9322829/

The Coaching for Cognition in Alzheimer's (COCOA) trial The objectives of COCOA are to (1) test the effectiveness of data‐driven multimodal coaching for amelioration of cognitive decline, and (2) ...

3. trialx.com trialx.com/clinical-trials/listings/270229/the-prevention-trial-precision-recommendations-to-optimize-neurocognition/

Precision Recommendations to Optimize Neurocognition The first objective is to evaluate the efficacy of a coached, data-driven, multi-modal lifestyle intervention to treat cognitive decline.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10619101/

MyCOACH (COnnected Advice for Cognitive Health) Of the completed short-term clinical trials targeting SCD or MCI, improved dementia risk and cognitive outcomes have been demonstrated over a 6- ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05894954

Precision Medicine Approach for Early Dementia & Mild ... The goal of this clinical trial is to compare a precision medicine approach to the standard-of-care for people with mild cognitive impairment or early-stage ...

6. alz-journals.onlinelibrary.wiley.com alz-journals.onlinelibrary.wiley.com/doi/full/10.1002/trc2.12318

The Coaching for Cognition in Alzheimer's (COCOA) trial ... We hypothesize that multimodal interventions will ameliorate cognitive decline and that data-driven health coaching will increase compliance, ...

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

U.S. POINTER Lifestyle Intervention Improved Cognition Two lifestyle interventions in U.S. POINTER improved cognition in older adults at risk of cognitive decline. A structured intervention with ...

8. withpower.com withpower.com/clinical-trials/for-alzheimers-disease-near-long-beach-ca?page=3

80 Alzheimer's Disease Trials near Long Beach, CA The first objective is to evaluate the efficacy of a coached, data-driven, multi-modal lifestyle intervention to treat cognitive decline. Subjects will be ...