Digital Lifestyle Coaching for Alzheimer's Disease Prevention in APOE4 Carriers (WellderlyBrain)
9 juin 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
1200
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Katie Quartuccio
- Numéro de téléphone: 858-784-5219
- E-mail: kquartuccio@scripps.edu
Lieux d'étude
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California
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La Jolla, California, États-Unis, 92037
- Scripps Translational Research Institute
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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)
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur actif: Virtual Lifestyle Coaching
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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.
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Aucune intervention: 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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Plasma pTau217 Concentration
Délai: 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.
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Month 1, Month 6, Month 12
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Composite proteomic brain-aging score
Délai: Month 12
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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.
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Month 12
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Neuropsychological Test Composite Score
Délai: Month 1, Month 3, Month 6, Month 9, Month 12
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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.
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Month 1, Month 3, Month 6, Month 9, Month 12
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Physical Activity
Délai: 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.
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Continuously throughout study completion, an average of 1 year
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Patient Reported Physical Activity
Délai: Once per month throughout study completion, an average of 1 year
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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.
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Once per month throughout study completion, an average of 1 year
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Sleep Health via Oura Ring Sleep Score
Délai: Continuously throughout study completion, an average of 1 year
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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.
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Continuously throughout study completion, an average of 1 year
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Patient Reported Sleep Quality
Délai: Once per month throughout study completion, an average of 1 year
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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.
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Once per month throughout study completion, an average of 1 year
|
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Heart Rate Variability
Délai: 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.
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Continuously throughout study completion, an average of 1 year
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Dietary Changes
Délai: Once per month throughout study completion, an average of 1 year
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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.
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Once per month throughout study completion, an average of 1 year
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Eric J Topol, MD, Scripps Translational Research Institute
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Liens utiles
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
6 juillet 2026
Achèvement primaire (Estimé)
31 juillet 2028
Achèvement de l'étude (Estimé)
31 décembre 2028
Dates d'inscription aux études
Première soumission
2 juin 2026
Première soumission répondant aux critères de contrôle qualité
9 juin 2026
Première publication (Réel)
12 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
12 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
9 juin 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies du cerveau
- Maladies du système nerveux central
- Maladies du système nerveux
- Les troubles mentaux
- Troubles neurocognitifs
- Troubles cognitifs
- Démence
- Tauopathies
- Maladies neurodégénératives
- Dysfonctionnement cognitif
- Maladie d'Alzheimer
- Facteurs socioéconomiques
- Caractéristiques de la population
- Statut éducatif
Autres numéros d'identification d'étude
- ScrippsRTI
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime IPD
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.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .