Digital Lifestyle Coaching for Alzheimer's Disease Prevention in APOE4 Carriers
NCT07646054 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1200
Last updated 2026-06-12
Summary
Wellderly Brain is a randomized, direct-to-participant trial evaluating whether a virtually delivered, multidomain lifestyle coaching intervention can favorably impact plasma biomarkers of Alzheimer's disease (AD) in adults aged 60-80 with APOE4 positivity or elevated polygenic risk. Participants are recruited through 23andMe and enrolled via the MyDataHelps platform. Following genetic eligibility screening, 1,200 participants will be randomized to either a digital lifestyle coaching arm (UCardia) or an education-only control arm. The intervention consists of 16 virtual coaching sessions delivered over 52 weeks. All participants will wear an Oura Ring for continuous health monitoring and provide dried blood samples at baseline, 6 months, and 12 months for plasma p-tau217 and proteomic profiling via the NULISAseq CNS Disease Panel. Saliva samples will be collected for epigenetic aging analysis. The study duration is 14-16 months per participant.
Conditions
- Mild Cognitive Impairment (MCI)
- Alzheimer Disease (AD)
Interventions
- BEHAVIORAL
-
Education
Treatment group will recieve 16 virtual lifestyle coaching sessions with a certified wellness coach over the course of 52 weeks. Education will focus on activity and sleep (with guidance from Oura ring) and anti inflammatory diet.
Sponsors & Collaborators
-
Sapient Bioanalytics
collaborator UNKNOWN -
TEAL Rise
collaborator UNKNOWN -
23andMe, Inc.
collaborator INDUSTRY -
Alamar Biosciences
collaborator UNKNOWN -
Oura Ring, Inc
collaborator UNKNOWN -
Scripps Translational Science Institute
lead OTHER
Principal Investigators
-
Eric J Topol, MD · Scripps Translational Research Institute
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 60 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-07-06
- Primary Completion
- 2028-07-31
- Completion
- 2028-12-31
Countries
- United States
Study Locations
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