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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07646054 on ClinicalTrials.gov