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

NCT07646054 | Not Yet Recruiting

• 1 other identifier: ScrippsRTI
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Alzheimers; Alzheimer Disease (AD)

Outcome Measures

Primary Outcomes (1)

• Plasma pTau217 Concentration

  Plasma phosphorylated tau 217 (pTau217) concentration will be measured from self-collected dried blood spot samples at three timepoints across the 12-month active monitoring period. Both absolute concentration at each time point and change from baseline will be assessed.

  Month 1, Month 6, Month 12

Secondary Outcomes (2)

• Composite proteomic brain-aging score

  Month 12

• Neuropsychological Test Composite Score

  Month 1, Month 3, Month 6, Month 9, Month 12

Other Outcomes (6)

• Physical Activity

  Continuously throughout study completion, an average of 1 year

• Patient Reported Physical Activity

  Once per month throughout study completion, an average of 1 year

• Sleep Health via Oura Ring Sleep Score

  Continuously throughout study completion, an average of 1 year

Study Arms (2)

Virtual Lifestyle Coaching

ACTIVE COMPARATOR

Behavioral: Education

Standard of Care

NO INTERVENTION

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.

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.

Virtual Lifestyle Coaching

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Scripps Translational Science Institute: lead
• Sapient Bioanalytics: collaborator
• TEAL Rise: collaborator
• 23andMe, Inc.: collaborator
• Alamar Biosciences: collaborator
• Oura Ring, Inc: collaborator

Study Sites (1)

Scripps Translational Research Institute

La Jolla, California, 92037, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Eric J Topol, MD

  Scripps Translational Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katie Quartuccio

CONTACT

858-784-5219; kquartuccio@scripps.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: June 12, 2026
• Study Start (Estimated): July 6, 2026
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)