Digital Lifestyle Coaching for Alzheimer's Disease Prevention in APOE4 Carriers
NCT07646054, Not applicable, Enrolling by invitation, Scripps Translational Science Institute
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Digital Lifestyle Coaching for Alzheimer's Disease Prevention in APOE4 Carriers | ClinicalTrials.gov |
| NCT number | NCT07646054 | ClinicalTrials.gov |
| Status | Enrolling by invitation | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 1,200 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Scripps Translational Science Institute | ClinicalTrials.gov |
| Conditions | Mild Cognitive Impairment (MCI), Alzheimer Disease (AD) | ClinicalTrials.gov |
| Interventions | Education | ClinicalTrials.gov |
| First posted | 2026-06-12 | ClinicalTrials.gov |
| Last updated | 2026-10-14 | ClinicalTrials.gov |
Registered outcomes 9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Plasma pTau217 Concentration | 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. | ClinicalTrials.gov |
| Secondary | Composite proteomic brain-aging score | 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. | ClinicalTrials.gov |
| Secondary | Neuropsychological Test Composite Score | 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. | ClinicalTrials.gov |
| Other | Physical Activity | 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. | ClinicalTrials.gov |
| Other | Patient Reported Physical Activity | 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. | ClinicalTrials.gov |
| Other | Sleep Health via Oura Ring Sleep Score | 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. | ClinicalTrials.gov |
| Other | Patient Reported Sleep Quality | 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. | ClinicalTrials.gov |
| Other | Heart Rate Variability | 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. | ClinicalTrials.gov |
| Other | Dietary Changes | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 3
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)