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

9. juni 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

1200

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Forenede Stater
    • California
      • La Jolla, California, Forenede Stater, 92037
        • Scripps Translational Research Institute

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Virtual Lifestyle Coaching
Adfærdsmæssigt: Education
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 indgriben: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Scripps Translational Science Institute

Samarbejdspartnere

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

Efterforskere

  • Ledende efterforsker: Eric J Topol, MD, Scripps Translational Research Institute

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

6. juli 2026

Primær færdiggørelse (Anslået)

31. juli 2028

Studieafslutning (Anslået)

31. december 2028

Datoer for studieregistrering

Først indsendt

2. juni 2026

Først indsendt, der opfyldte QC-kriterier

9. juni 2026

Først opslået (Faktiske)

12. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ScrippsRTI

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Mild kognitiv svækkelse (MCI)

Kliniske forsøg med Education

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Betingelser

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Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

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