Predicting Pre-dementia

Part of paid clinical trials in San Diego, California.

Sponsor
Prevention Research Consortium Corp.
Study ID
NCT07516119
Status
Recruiting
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Conditions

  • APOE-4 Positive
  • Alzheimer Dementia (AD)
  • Alzheimer Disease (AD)
  • Mild Cognitive Impairment (MCI)

Eligibility Criteria

Sex
ALL
Age
55 Years - N/A
Healthy Volunteers
Accepted

Study Details

The goal of this observational study is to learn how well a multimodal "Progression and Risk" (PR) model can predict and stage early mild cognitive impairment (MCI) due to Alzheimer's disease in cognitively normal or very mildly impaired ApoE4-positive adults aged 55 and older. The main questions it aims to answer are: Can a prespecified proteogenomic PR model accurately predict conversion from cognitively normal (CN) or very mildly impaired status to pTau217-positive MCI Stage I within 24 months in ApoE4-positive adults? Does adding digital monitoring features (e.g., sleep, activity, speech), EMR-lifestyle risk scores, and plasma biomarkers to a polygenic risk score (PRS) meaningfully improve risk stratification and time-to-conversion prediction compared with simpler models (e.g., PRS alone or standard clinical risk factors)? If there is a comparison group: Researchers will compare performance of the full multimodal PR model (integrating PRS, plasma proteomics and other omics, digital monitoring, and EMR-lifestyle data) with simpler or reduced models (for example, PRS-only, biomarker-only, or models without continuous digital monitoring) to see if the full model provides higher discrimination (AUC/ROC), better calibration, and improved time-to-conversion prediction for CN to pTau217-positive MCI transitions. Participants will: Provide prior genomic data (ApoE genotype and whole-genome sequencing or high-density genotyping array data) for calculation of an ancestry- and sex-normalized Alzheimer's disease PRS and assignment to PRS-based risk strata. Attend an in-person baseline visit and follow-up visits at months 6, 12, 18, and 24 (±2 months) for clinical evaluation, neurocognitive testing (including CDR and digital cognitive batteries), and venous or capillary blood collection for plasma pTau217 and other AD biomarkers, proteomic and methylome panels, and routine safety labs when indicated. Use digital devices (e.g., Oura Ring and smartphone-based tools) for continuous or frequent remote monitoring of sleep, activity, heart rate metrics, mobility/location, and speech-linked digital cognitive tasks, with adherence checks at study visits. Undergo optional or sub-cohort procedures as clinically indicated or as resources allow, such as EEG, retinal hyperspectral imaging, MRI, or amyloid PET, and optionally allow clinically indicated lumbar puncture CSF samples and external clinical data to be shared with the study for exploratory biomarker analyses.

Key Dates

Start date
Apr 15, 2026
Status verified
Mar 2026
Primary completion
Apr 15, 2029
Completion
Apr 15, 2029

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: Oura Ring and Apple Kit
    Digital Biomarkers
  • Arm: Non Digital Biomarker
    Non Digital Biomarker Group
  • Arm: Food for the Brain
    Digital Cognitive Screening
  • Arm: Punto Test
    Speech Biomarker Screening
  • Arm: No Cognitive Screening
    No cognitive Screening performed

Primary Outcome Measure

Conversion from Cognitively Normal (CN) pTau217 Negative to pTau217-Positive [ Time Frame: 0-24 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Foster Carr MDSan DiegoCalifornia92101
Foster Carr, MD
[email protected]
8772716078

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Foster Carr MD· San Diego, CA

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