Digital Lifestyle Coaching for Alzheimer's Disease Prevention in APOE4 Carriers
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-80
SponsorScripps Translational Science Institute
About this trial
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.
Eligibility criteria
Qualifiers
Current 23andMe Research participant with APOE4 positivity genetic variant
Age 60 to 80 at time of consent
Have access to an Android or Apple iPhone smartphone device and able to download study apps
Lives in the United States and able to send and receive US Mail
Disqualifiers
Non-English speaking
Lives outside of the United States
Currently taking or planning on taking GLP-1 medications (Exenatide, Liraglutide, Albiglutide, Dulaglutide, Semaglutide or Tirzepatide) within the next 12 months
Established diagnosis of Mild Cognitive Impairment, Alzheimer's Disease or other Neurodegenerative Disease (Parkinson's Disease, Amyotrophic Lateral Sclerosis, Huntington's Disease, Multiple Sclerosis or Frontotemporal Dementia).
Trial design
Treatments tested in this trial
- Education
Treatment groups
1,200 Participants
are divided into 2 treatment groupsSponsors and collaborators
Scripps Translational Science Institute
Lead sponsor
Sapient Bioanalytics
Collaborator
TEAL Rise
Collaborator
23andMe, Inc.
Collaborator
Alamar Biosciences
Collaborator
Oura Ring, Inc
Collaborator
Source ClinicalTrials.gov