Digital Lifestyle Coaching for Alzheimer's Disease Prevention in APOE4 Carriers (NCT07646054) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Digital Lifestyle Coaching for Alzheimer's Disease Prevention in APOE4 Carriers
United States1,200 participantsStarted 2026-07-06
Plain-language 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.
Who can participate
Age range
60 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
* Able and willing to perform a self-administered saliva test at screening\*for organic outreach only.
* Able and willing to perform a self-administered finger prick blood collection at three time points throughout the study.
Exclusion Criteria:
* 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).
* Current or past Oura Ring user (any Oura Ring use in the last 12 months)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is focused on APOE4 carriers specifically, should I get genetic testing to find out if I carry the APOE4 gene before we even consider whether this study might be relevant to my situation?
2The trial is measuring plasma pTau217, which is a blood biomarker linked to Alzheimer's disease progression — can you explain what changes in that marker would actually mean for my health, and how meaningful that outcome is compared to something like memory test scores?
3This trial isn't recruiting yet, so there could be a significant wait before it opens — given where I am right now with my mild cognitive impairment, is waiting potentially worthwhile, or would it make more sense to start on an established care plan in the meantime?
4The intervention is described as 'digital lifestyle coaching,' which sounds like it involves remote or app-based tools — is that kind of format realistic for my daily routine and tech comfort level, and would you still be directly involved in my care if I joined something like this?
5Since this is a lifestyle-based prevention study rather than a drug trial, how does it compare to standard recommendations you might already make for someone in my situation, and is there anything in this approach that goes meaningfully beyond what we could do together right now?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.