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NCT Number: NCT07646054

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

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.

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Key information

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Scripps Translational Research Institute

La Jolla, California, 92037, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Plasma pTau217 Concentration

    Time frame: Month 1, Month 6, Month 12

    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.

Secondary outcomes

  1. Composite proteomic brain-aging score

    Time frame: Month 12

    A composite proteomic brain-aging score will be derived from proteomic biomarkers associated with biological brain aging, measured via dried blood spot samples collected from participants. The score represents estimated biological brain age relative to chronological age; lower scores indicate a younger biological brain. Analysis will be restricted to participants who return all required dried blood spot samples.

  2. Neuropsychological Test Composite Score

    Time frame: Month 1, Month 3, Month 6, Month 9, Month 12

    A composite neuropsychological score will be derived from repeated administration of validated online cognitive assessments, including the Stroop Test, Processing Speed Assessment Test (PSAT), and Trail Making Test, spanning cognitive domains of attention, processing speed, executive function, and cognitive flexibility over time. The direction of the composite score will be defined in the statistical analysis plan. Both composite score at each time point and change from baseline will be assessed.

Other outcomes

  1. Physical Activity

    Time frame: Continuously throughout study completion, an average of 1 year

    Physical activity will be assessed continuously via Oura Ring throughout the 12-month study period. Metrics may include daily movement, step count, activity volume, energy expenditure, and overall activity score. Both metric values at each time point and change from baseline will be assessed.

  2. Patient Reported Physical Activity

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

    Self-reported physical activity will be assessed monthly via participant questionnaire measuring average duration, frequency, and intensity of physical activity performed during each assessment period.

  3. Sleep Health via Oura Ring Sleep Score

    Time frame: Continuously throughout study completion, an average of 1 year

    Sleep health will be assessed continuously via Oura Ring wearable device throughout the 12-month study period. Sleep metrics include total sleep duration, sleep efficiency, REM sleep, deep sleep, sleep latency, sleep timing, restlessness, breathing regularity, blood oxygen saturation, and heart rate variability (HRV), which are combined to generate the Oura Sleep Score (range: 0-100; higher scores indicate better sleep quality). Both Sleep Score at each time point and change from baseline will be assessed.

  4. Patient Reported Sleep Quality

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

    Subjective sleep quality will be assessed monthly via an 11-point rating scale (range: 0-10) measuring how refreshed participants feel upon waking. Higher scores indicate better subjective sleep quality.

  5. Heart Rate Variability

    Time frame: Continuously throughout study completion, an average of 1 year

    Heart rate variability (HRV) will be assessed continuously via Oura Ring wearable device throughout the 12-month study period. Higher HRV trends over time are interpreted as indicative of better cardiovascular health. Both HRV values at each time point and change from baseline will be assessed.

  6. Dietary Changes

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

    Self-reported dietary behaviors will be assessed monthly via participant questionnaire. Measures include dietary pattern adherence (e.g., specific diet type followed), macronutrient and food group intake changes (e.g., protein and vegetable consumption), and self-reported weight changes throughout the study period.

Study contacts

Contact information is provided by the study sponsor or research team.

Katie Quartuccio

CONTACT

[email protected]

858-784-5219

Sponsors and collaborators

Lead sponsor

Scripps Translational Science Institute

Other

Collaborators

  • 23andMe, Inc.
  • Alamar Biosciences
  • Oura Ring, Inc
  • Sapient Bioanalytics
  • TEAL Rise

Registry information

Official study title

Wellderly Brain - Alzheimer's Disease Prevention With Lifestyle Coaching Intervention: A Randomized Clinical Trial

Acronym: WellderlyBrain

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 12, 2026
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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