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

Part of paid clinical trials in La Jolla, California.

Sponsor
Scripps Translational Science Institute
Study ID
NCT07646054
Status
Not Yet Recruiting

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Conditions

  • Alzheimer Disease (AD)
  • Mild Cognitive Impairment (MCI)

Eligibility Criteria

Sex
ALL
Age
60 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Education — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Jul 6, 2026
Status verified
Jun 2026
Primary completion
Jul 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
1,200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Virtual Lifestyle Coaching
  • No Intervention: Standard of Care
    Participants will receive an Oura Ring with daily metrics of sleep and activity but no supplemental education of guidance on improving their scores. They will have access to current standard of care worksheets.

Primary Outcome Measure

Plasma pTau217 Concentration [ Time Frame: Month 1, Month 6, Month 12 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Scripps Translational Research InstituteLa JollaCalifornia92037-

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Scripps Translational Research Institute· La Jolla, CA

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