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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-80
SponsorScripps Translational Science Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

1,200 Participants
are divided into 2 treatment groups
Group A: Virtual Lifestyle CoachingActive comparator 1 intervention
Group B: Standard of CareNo intervention 0 interventions

Trial outcomes

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.

Time frame
Month 1, Month 6, Month 12

Secondary outcomes

1

Composite proteomic brain-aging score

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.

Time frame
Month 12
2

Neuropsychological Test Composite Score

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.

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

Other outcomes

1

Physical Activity

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.

Time frame
Continuously throughout study completion, an average of 1 year
2

Patient Reported Physical Activity

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.

Time frame
Once per month throughout study completion, an average of 1 year
3

Sleep Health via Oura Ring Sleep Score

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.

Time frame
Continuously throughout study completion, an average of 1 year
4

Patient Reported Sleep Quality

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.

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Scripps Translational Science Institute

Lead sponsor

Sapient Bioanalytics

Collaborator

TEAL Rise

Collaborator

23andMe, Inc.

Collaborator

Alamar Biosciences

Collaborator

Oura Ring, Inc

Collaborator

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