Digital Lifestyle Coaching for Alzheimer's Disease Prevention in APOE4 Carriers (WellderlyBrain)
2026年6月9日 更新者：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.
調査の概要
研究の種類
介入
入学 (推定)
1200
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Katie Quartuccio
- 電話番号：858-784-5219
- メール：kquartuccio@scripps.edu
研究場所
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California
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La Jolla、California、アメリカ、92037
- Scripps Translational Research Institute
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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)
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：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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介入なし：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Plasma pTau217 Concentration
時間枠：Month 1, Month 6, Month 12
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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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Composite proteomic brain-aging score
時間枠：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
時間枠：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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Physical Activity
時間枠：Continuously throughout study completion, an average of 1 year
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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
時間枠：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
時間枠：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
時間枠：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
時間枠：Continuously throughout study completion, an average of 1 year
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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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Eric J Topol, MD、Scripps Translational Research Institute
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
便利なリンク
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年7月6日
一次修了 (推定)
2028年7月31日
研究の完了 (推定)
2028年12月31日
試験登録日
最初に提出
2026年6月2日
QC基準を満たした最初の提出物
2026年6月9日
最初の投稿 (実際)
2026年6月12日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月12日
QC基準を満たした最後の更新が送信されました
2026年6月9日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- ScrippsRTI
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
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.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。