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

Scripps Translational Science Institute

Status

Begins enrollment this month

Conditions

Mild Cognitive Impairment (MCI)

Alzheimer Disease (AD)

Treatments

Behavioral: Education

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT07646054

ScrippsRTI

Details and patient eligibility

About

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.

Enrollment

1,200 estimated patients

Sex

All

Ages

60 to 80 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1,200 participants in 2 patient groups

Virtual Lifestyle Coaching

Active Comparator group

Treatment:

Behavioral: Education

Standard of Care

No Intervention group

Description:

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.

Trial contacts and locations

Central trial contact

Katie Quartuccio

Data sourced from clinicaltrials.gov

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