NCT06375213 · RECRUITING

Investigating Neurocognitive Disorders Epidemiology

This observational study is tracking people in Thailand across a spectrum of cognitive health, from fully healthy to MCI to dementia, to see whether a blood biomarker called phosphorylated tau (p-tau217) can predict who will decline and how fast. Participants give blood samples and take cognitive tests, then return for follow-up visits over time. There is no drug or treatment involved. This is an epidemiology study, meaning it observes rather than intervenes.

Eligibility criteria

1. Cognitively Healthy Individuals
   INCLUSION CRITERIA
   * Demonstrate normal cognitive function within the expected range on objective cognitive tests.
   * Proficient in speaking and understanding Thai without the need for a translator to participate.
   EXCLUSION CRITERIA
   * Significant neurological or uncontrolled psychiatric illness.
   * Significant unstable systemic condition or end-stage organ failure that affects study participation.
2. Mild Cognitive Impairment
   INCLUSION CRITERIA
   * Display impaired/abnormal performance on objective cognitive tests.
   * Does not meet criteria for dementia per NIA-AA (or major neurocognitive disorder per DSM-5).
   * Proficient in speaking and understanding Thai without the need for a translator to participate.
   EXCLUSION CRITERIA
   * Significant neurological or uncontrolled psychiatric illness.
   * Significant unstable systemic condition or end-stage organ failure that affects study participation.
3. Late Onset Dementia
   INCLUSION CRITERIA
   * Display impaired/abnormal performance on objective cognitive tests.
   * Meets criteria for dementia per NIA-AA (or major neurocognitive disorder per DSM-5), including dementia due to Alzheimer's disease or other causes.
   * Begins to experience symptoms, identified by the physician as a part of dementia continuum, occurring after the age of 65.
   * Proficient in speaking and understanding Thai without the need for a translator to participate.
   EXCLUSION CRITERIA
   * Significant neurological or uncontrolled psychiatric illness.
   * Significant unstable systemic condition or end-stage organ failure that affects study participation.
4. Early Onset Dementia
INCLUSION CRITERIA
* Display impaired/abnormal performance on objective cognitive tests.
* Meets criteria for dementia per NIA-AA (or major neurocognitive disorder per DSM-5), including dementia due to Alzheimer's disease or other causes.
* Begins to experience symptoms, identified by the physician as a part of dementia continuum, occurring before the age of 65.
* Proficient in speaking and understanding Thai without the need for a translator to participate.
EXCLUSION CRITERIA
* Significant neurological or uncontrolled psychiatric illness.
* Significant unstable systemic condition or end-stage organ failure that affects study participation.

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 2024-04-22

View full record on ClinicalTrials.gov

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