Digital Lifestyle Coaching for Alzheimer's Disease Prevention in APOE4 Carriers (WellderlyBrain)
9. juni 2026 oppdatert av: Scripps Translational Science Institute
Wellderly Brain - Alzheimer's Disease Prevention With Lifestyle Coaching Intervention: A Randomized Clinical 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
1200
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Katie Quartuccio
- Telefonnummer: 858-784-5219
- E-post: kquartuccio@scripps.edu
Studiesteder
-
-
California
-
La Jolla, California, Forente stater, 92037
- Scripps Translational Research Institute
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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)
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Virtual Lifestyle Coaching
|
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.
|
|
Ingen inngripen: Standard of Care
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Plasma pTau217 Concentration
Tidsramme: 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.
|
Month 1, Month 6, Month 12
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Composite proteomic brain-aging score
Tidsramme: 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.
|
Month 12
|
|
Neuropsychological Test Composite Score
Tidsramme: 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.
|
Month 1, Month 3, Month 6, Month 9, Month 12
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Physical Activity
Tidsramme: 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.
|
Continuously throughout study completion, an average of 1 year
|
|
Patient Reported Physical Activity
Tidsramme: 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.
|
Once per month throughout study completion, an average of 1 year
|
|
Sleep Health via Oura Ring Sleep Score
Tidsramme: 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.
|
Continuously throughout study completion, an average of 1 year
|
|
Patient Reported Sleep Quality
Tidsramme: 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.
|
Once per month throughout study completion, an average of 1 year
|
|
Heart Rate Variability
Tidsramme: 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.
|
Continuously throughout study completion, an average of 1 year
|
|
Dietary Changes
Tidsramme: 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.
|
Once per month throughout study completion, an average of 1 year
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Eric J Topol, MD, Scripps Translational Research Institute
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
6. juli 2026
Primær fullføring (Antatt)
31. juli 2028
Studiet fullført (Antatt)
31. desember 2028
Datoer for studieregistrering
Først innsendt
2. juni 2026
Først innsendt som oppfylte QC-kriteriene
9. juni 2026
Først lagt ut (Faktiske)
12. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
12. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
9. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ScrippsRTI
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
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.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .