An interventional study of Education in Mild Cognitive Impairment (MCI) and Alzheimer Disease (AD), sponsored by Scripps Translational Science Institute. Enrolling by invitation at 1 site in United States. Open to participants aged 60 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by Scripps Translational Science Institute · Not applicable, Interventional, and Prevention
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.
3,872 studies on the registry are indexed under Cognitive Dysfunction; 1,119 are open to participants now.
This study's planned enrollment of 1,200 is above the median of 64 across 2,794 interventional studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →Scripps Translational Science Institute is the lead sponsor of 53 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Behavioral: Education
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.
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.
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
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
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
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
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
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
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
Heart Rate Variability
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.
Time frame: Continuously throughout study completion, an average of 1 year
Dietary Changes
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.
Time frame: Once per month throughout study completion, an average of 1 year
Plan to share: No — The investigators may share the coded study data with researchers outside of Scripps Research. Before doing so, they will ensure that nothing in the data can identify the participant directly.
Started Aug 2026 (actual). Primary completion is estimated for Aug 2028, 24 months after the start.
Of 1,442 non-industry interventional studies with no phase under Cognitive Dysfunction, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 51. This study's planned 24 months is below that.
Counting every sponsor, half of 1,511 studies reached it within 27 months; a quarter within 12 and three quarters within 50.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 14, 2026: start Jul 2026 → Aug 2026 and primary completion Jul 2028 → Aug 2028.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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