RecruitingPhase not listed

Predicting Pre-dementia

Assessing Tools That Predict and Stage Mild Cognitive Impairment

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
55 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 2 years
  • Procedures mentioned: MRI scans, Spinal tap (lumbar puncture), Wearing a device, Blood draws, PET scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "This is an observational, first-in-human (FIH) cohort study that follows ApoE4-positive adults over two years to see how well a multimodal "Progression and Risk" (P\&R) model can predict who will develop very early, biomarker-confirmed mild cognitive impairment (MCI) due to Alzheimer's disease."
  • "The study combines genetic risk, blood biomarkers, digital testing, and wearable data to stage risk in people who are currently cognitively normal or only very mildly affected."
  • "Overall goals and main questions This study's overarching aim is to validate a fixed proteogenomic P\&R model in a real-world group of ApoE4-positive older adults and to assess whether such a model can feasibly be implemented using a combination of existing genomic data, blood tests, and scalable digital monitoring."
  • "How practical and acceptable is it to carry out this kind of multimodal assessment-combining existing genetic data, repeated blood tests, digital cognitive and speech measures, and continuous wearable monitoring-over a two-year period in this population?"
  • "A subset of about ten participants will have especially intensive wearable monitoring."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well a model using gene data, blood tests, health records, and digital tracking can predict early memory and thinking problems linked to Alzheimer's disease over 2 years. It is for adults age 55 or older who carry the APOE4 gene variant and have no or very mild thinking problems.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 55 or older.
  • Past gene testing shows at least one copy of APOE4, a gene variant linked to Alzheimer's risk.
  • Have existing whole-genome data or suitable gene test data to share. The study does not do these gene tests.
  • Have normal thinking skills or very mild problems on study tests, with no dementia diagnosis.
  • Do not already have mild cognitive impairment (memory and thinking problems) with a high pTau217 level, a sign of Alzheimer's found in blood or spinal fluid.
  • Can give informed consent and take part in visits, thinking tests, and sample collection, with an authorized representative involved when allowed.
  • Willing to use required digital devices and apps for tracking and thinking and speech tests.
  • Willing to sign forms allowing access to existing gene data and needed health records.

Who can't join

  • Already have dementia, or mild cognitive impairment with a positive pTau217 test.
  • Have a major brain or nerve condition that could affect study results, such as Parkinson's, a stroke with lasting problems, or frequent seizures.
  • Have a major mental health condition that seriously affects participation or results, such as uncontrolled depression or schizophrenia.
  • Have an uncontrolled illness expected to limit life to less than about 3 years, such as unstable heart, liver, or kidney disease.
  • Used an experimental drug or an Alzheimer's treatment meant to change the disease course within the past 6 months, if it could affect study results.
  • Cannot or will not use the required digital tools.
  • Lack required APOE4 proof or suitable gene data, or will not share needed gene data and health records.
  • Are a child, a prisoner, or pregnant.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: Age Age 55 years or older at enrollment. APOE Genotype Documented carrier of at least one APOE ε4 allele, based on prior testing (e.g., clinical APOE testing, prior genetic panel, research cohort genotyping, or direct-to-consumer testing). Existing Genomic Data for PRS Whole-genome sequencing (WGS) data already completed, with willingness to provide existing WGS data files (e.g., VCF, FASTQ, or equivalent) to the study team for Alzheimer's disease polygenic risk score (PRS) calculation; or If WGS is not available, prior high-density or targeted genotyping array data covering Alzheimer's disease risk loci, with willingness to provide these data for PRS calculation (feasibility of array-based PRS will be evaluated case-by-case). Note: The study does not perform APOE genotyping or WGS as part of the research; these must be completed before enrollment. Cognitive Status at Baseline Cognitively normal or very mildly impaired at baseline, defined by: Digital cognitive assessment and/or Punto Test consistent with a Global Clinical Dementia Rating (CDR) of 0 or 0.5. No clinical diagnosis of dementia. For cognitively normal (CN) and subjective cognitive decline (SCD) participants, staging by the Progression and Risk (P\&R) model (combining PRS, biomarker, and cognitive data) will be applied for risk stratification. Absence of Baseline AD-MCI by Biomarkers Does not currently qualify for Alzheimer's disease-related MCI (AD-MCI), operationalized as no evidence of MCI with plasma or CSF pTau217 level above a validated cutoff for AD-MCI pathology. Capacity and Participation Ability Able to provide informed consent (with capacity assessments and, where applicable, involvement of a legally authorized representative per institutional policy and IRB approval). Able and willing to comply with study procedures, including clinic visits, cognitive testing, and biospecimen collection. Willingness to Use Digital Monitoring Tools Willing to wear and/or carry digital devices for continuous or frequent monitoring (e.g., smartphone app, wearable sensors such as Oura Ring, sleep device), and to participate in app-based cognitive and speech assessments. Data-Sharing Authorizations Willingness to sign data release authorizations allowing the study to obtain existing genomic data (WGS or array) and relevant electronic medical record (EMR) data needed for risk modeling and outcome adjudication. Exclusion Criteria: Baseline Dementia Diagnosis Clinical diagnosis of dementia of any cause at baseline. Major Neurological Disorders Affecting Cognition History of major neurological conditions that in the investigator's judgment may confound cognitive assessment or outcomes, such as: Parkinson's disease. Stroke with residual neurological deficits. Epilepsy with frequent seizures. Major Psychiatric Illness Major psychiatric disorders that significantly interfere with participation or data interpretability, such as uncontrolled major depressive disorder or schizophrenia, as judged by the investigator. Serious or Unstable Medical Conditions Uncontrolled systemic medical illness expected to limit life expectancy to less than approximately 3 years, including but not limited to unstable cardiac, hepatic, or renal disease. Recent Investigational or Disease-Modifying AD Treatments Use of investigational drugs or disease-modifying Alzheimer's therapies within 6 months prior to baseline, if such treatments are likely to confound biomarker trajectories or cognitive outcomes. Inability or Unwillingness to Use Required Digital Tools Lack of Required Genomic Documentation or Refusal to Share Data No prior APOE genotype documenting at least one ε4 allele; or No available WGS or suitable genotyping array data; or Refusal to share existing APOE/genomic data and necessary EMR data with the study team. Baseline MCI with Positive pTau217 Vulnerable Populations Not Targeted Children, prisoners, and pregnant individuals are not specifically targeted and will be excluded from enrollment.

Study sites (1)

CA