Digital Lifestyle Coaching for Alzheimer's Disease Prevention in APOE4 Carriers

Study acronym: WellderlyBrain
StatusEnrolling by Invitation
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 31 days later Jul 31, 2028 → Aug 31, 2028
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Record History

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  1. Enrolling by invitation only Show 4 more changesShow less
    • Primary completion pushed from Jul 31, 2028 to Aug 31, 2028
    • Start date changed from estimate of Jul 6, 2026 to Aug 6, 2026
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 2 of 2 entries
  2. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
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.
Trial Details
NCT Number NCT07646054
Lead Sponsor Scripps Translational Science Institute
Collaborators: Sapient Bioanalytics, TEAL Rise, 23andMe, Inc., Alamar Biosciences, Oura Ring, Inc
Conditions
(from sponsor)		 Mild Cognitive Impairment (MCI), Alzheimer Disease (AD)
Related terms Alzheimer Disease, Cognitive Dysfunction
Enrollment 1,200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov