NCT07660263 · NOT YET RECRUITING

Development of a Genomics-based Multimodal Prediction Model for Post-stroke Vascular Dementia

This study is collecting detailed data from stroke survivors and healthy adults to build a prediction model for who might develop vascular dementia after a stroke. Researchers will gather genetic information, brain scans, cognitive test results, and health records. It is an observational study, not a treatment trial, meaning no intervention is being tested. The goal is a risk-prediction tool, not a therapy. Details on phase are not specified.

Eligibility criteria

Inclusion Criteria:
1. Healthy Control Group:
   * Adults aged 19 years or older.
   * Able to be age- and sex-matched to the stroke cohort.
   * No history of stroke, transient ischemic attack (TIA), or other central nervous system disorders.
   * Cognitive function within the normal range for age and education level based on screening assessments (K-MMSE and K-MoCA).
   * Able to understand the study procedures and provide written informed consent.
2. Stroke Patient Group:
   * Adults aged 19 years or older.
   * First-ever ischemic or hemorrhagic stroke confirmed by CT or MRI.
   * Enrolled in one of the following strata according to time since stroke onset:
Stratum A: 7 days to 3 months after stroke onset. Stratum B: >3 months to 12 months after stroke onset. Stratum C: >12 months to 36 months after stroke onset.
- Able to understand the study procedures and provide written informed consent, or consent provided by a legally authorized representative when applicable.
Exclusion Criteria:
1. Healthy Control Group:
   * Current severe psychiatric disorders that may affect cognitive function (e.g., major depression, schizophrenia) or use of related medications.
   * Strong family history of hereditary cerebrovascular disorders (e.g., CADASIL).
   * Severe medical illness considered inappropriate for study participation.
   * Any condition that, in the opinion of the investigator, would make participation unsuitable.
2. Stroke Patient Group:
   * Impaired ability to provide consent (MMSE \<10) without an accompanying caregiver or legally authorized representative.
   * History of dementia due to causes other than stroke (e.g., Alzheimer's disease) prior to stroke onset.
   * History of major neurological disorders affecting cognition prior to stroke onset (e.g., Parkinson's disease, brain tumor, multiple sclerosis).
   * Severe aphasia or impaired consciousness preventing completion of cognitive assessments.
   * Current or pre-stroke severe psychiatric disorders that may affect cognitive function (e.g., major depression, schizophrenia) or use of related medications.
   * Strong family history of hereditary cerebrovascular disorders (e.g., CADASIL).
   * Contraindication to MRI (e.g., metallic implants) or refusal to provide blood samples for genomic analysis.
   * Any condition that, in the opinion of the investigator, would make participation unsuitable.

The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.

Eligibility criteria as of 2026-06-22

View full record on ClinicalTrials.gov

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