Digital Lifestyle Coaching for Alzheimer's Disease Prevention in APOE4 Carriers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Education.
- Who it may be relevant to
- Registry conditions: Mild Cognitive Impairment (MCI), Alzheimer Disease (AD). Basic parameters: 60 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Wellderly Brain - Alzheimer's Disease Prevention With Lifestyle Coaching Intervention: A Randomized Clinical Trial
Overview
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.
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.
Primary outcome measures
- Plasma pTau217 Concentration [Time frame: Month 1, Month 6, Month 12]
Secondary outcome measures (2)
- Composite proteomic brain-aging score [Time frame: Month 12]
- Neuropsychological Test Composite Score [Time frame: Month 1, Month 3, Month 6, Month 9, Month 12]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Scripps Translational Research Institute — La Jolla
Identifiers
NCT: NCT07646054 · ScrippsRTI