Digital Lifestyle Coaching for Alzheimer's Disease

(WellderlyBrain Trial)

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Scripps Translational Science Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if digital lifestyle coaching can improve blood markers linked to Alzheimer's disease in adults with a higher genetic risk for the condition. Participants will use an app for coaching over a year and provide blood and saliva samples for analysis. It targets individuals aged 60 to 80 who are part of 23andMe research, possess a specific genetic marker (APOE4), and can use a smartphone. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to new preventive strategies for Alzheimer's disease.

What prior data suggests that this digital lifestyle coaching is safe for participants?

Research has shown that digital lifestyle coaching is generally safe and well-received by participants. Studies have found that these programs can lead to positive results without major side effects. The focus on lifestyle changes, such as exercise and diet, usually involves minimal risk. Participants often report high satisfaction and find these programs easy to follow and helpful.

Since this trial tests a lifestyle approach rather than a new drug, the risks remain low. Participants engage in activities like virtual coaching sessions, which are unlikely to cause harm. Overall, previous research supports the safety of digital lifestyle programs in similar situations.

Why are researchers excited about this trial?

Unlike the standard care options for Alzheimer's, which often include medications like donepezil or memantine, Digital Lifestyle Coaching offers a fresh approach by focusing on behavior and lifestyle changes through virtual coaching. Researchers are excited about this method because it leverages technology to deliver personalized guidance, potentially improving cognitive health by encouraging healthier daily habits. This approach not only empowers patients by giving them active roles in managing their condition but also promises a more engaging and accessible way to complement traditional treatments.

What evidence suggests that digital lifestyle coaching is effective for Alzheimer's disease?

Research has shown that digital lifestyle coaching might help reduce the risk of Alzheimer's disease. In this trial, participants will receive either Virtual Lifestyle Coaching or Standard of Care. Studies have found that personalized coaching can slow memory and thinking problems more effectively than standard treatment alone. For instance, health coaching has been linked to lower risks of other health issues like diabetes, which can affect Alzheimer's risk. Additionally, digital health coaching may improve brain function and reduce the chance of developing dementia. Overall, these findings suggest that digital lifestyle coaching could be useful in addressing factors that increase the risk of Alzheimer's disease.12345

Who Is on the Research Team?

EJ

Eric J Topol, MD

Principal Investigator

Scripps Translational Research Institute

Are You a Good Fit for This Trial?

This trial is for adults aged 60-80 in the US who have a genetic risk for Alzheimer's (APOE4 or high polygenic risk), are current 23andMe research participants, own a smartphone, and can do at-home saliva and finger-prick blood tests.

Inclusion Criteria

Lives in the United States and able to send and receive US Mail
I am able and willing to do a saliva test by myself.
I am between 60 and 80 years old.
See 3 more

Exclusion Criteria

Non-English speaking
Lives outside of the United States
Current or past Oura Ring user (any Oura Ring use in the last 12 months)
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a virtually delivered, multidomain lifestyle coaching intervention over 52 weeks

52 weeks
16 virtual coaching sessions

Monitoring

Continuous health monitoring via Oura Ring and collection of dried blood samples at baseline, 6 months, and 12 months

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

2-4 months

What Are the Treatments Tested in This Trial?

Interventions

  • Digital Lifestyle Coaching

Trial Overview

The study compares digital lifestyle coaching sessions to education-only materials to see if virtual coaching helps reduce Alzheimer’s disease markers in the blood. Participants are randomly assigned to one of these two groups and monitored over about 14-16 months.

How Is the Trial Designed?

2

Treatment groups

Active Control

Group I: Virtual Lifestyle CoachingActive Control1 Intervention
Group II: Standard of CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Scripps Translational Science Institute

Lead Sponsor

Trials
53
Recruited
572,000+

23andMe, Inc.

Industry Sponsor

Trials
10
Recruited
83,700+

Alamar Biosciences

Collaborator

Oura Ring, Inc

Collaborator

Sapient Bioanalytics

Collaborator

Trials
2
Recruited
1,100+

TEAL Rise

Collaborator

Citations

Digital Lifestyle Coaching for Alzheimer's Disease ...

Wellderly Brain is a randomized, direct-to-participant trial evaluating whether a virtually delivered, multidomain lifestyle coaching ...

Face-to-Face and Digital Multidomain Lifestyle Interventions to ...

The primary outcome measure will be Alzheimer's Disease risk factor, calculated using the shortened version of the Australian National University – Alzheimer's ...

The effect of a digital health coaching and health education ...

These results indicate that HC and HE can both improve cognition, but HC may be more effective and may yield increased protection against ADRD risk.

Personalized Coaching Decreases Cognitive Decline in ...

Personalized lifestyle coaching leads to less cognitive decline compared to standard of treatment alone, according to an ISB-led two-year study.

Initial Perspectives From Rural-Residing Adults on a Digital ...

Specifically, health coaching interventions have been linked to decreased risk of Alzheimer disease (AD) comorbidities, such as diabetes.