Actively Recruiting
Predicting Pre-dementia
Led by Prevention Research Consortium Corp. · Updated on 2026-04-07
100
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Predicting Pre-dementia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 55 years or older at enrollment.
- Documented carrier of at least one APOE 4 allele from prior genetic testing.
- Existing whole-genome sequencing (WGS) or high-density genotyping array data available for polygenic risk score calculation.
- Cognitively normal or very mildly impaired at baseline (Global Clinical Dementia Rating 0 or 0.5) with no diagnosis of dementia.
- Does not currently have Alzheimer's disease-related mild cognitive impairment with elevated plasma or CSF pTau217.
- Able to provide informed consent and comply with study procedures.
- Willing to use digital monitoring tools such as smartphone apps and wearable sensors.
- Willing to sign data release authorizations for genomic and electronic medical record data.
You will not qualify if you...
- Clinical diagnosis of dementia of any cause at baseline.
- Major neurological conditions affecting cognition, such as Parkinson's disease, stroke with residual deficits, or epilepsy with frequent seizures.
- Major psychiatric illnesses that interfere with participation or data interpretation, like uncontrolled major depression or schizophrenia.
- Serious uncontrolled medical illnesses expected to limit life expectancy to less than about three years.
- Use of investigational or disease-modifying Alzheimer's treatments within six months prior to baseline.
- Inability or unwillingness to use required digital monitoring tools.
- No prior APOE genotype showing at least one 4 allele, or no suitable genomic data available.
- Refusal to share existing genomic or electronic medical record data with the study.
- Already meet criteria for biomarker-positive mild cognitive impairment due to Alzheimer's at screening.
- Vulnerable populations such as children, prisoners, and pregnant individuals are excluded.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Foster Carr MD
San Diego, California, United States, 92101
Actively Recruiting
Research Team
F
Foster Carr, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
5
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