Clinical Trials in Japan / NCT07142954
Recruiting
Phase 3
Epidemiology and Biomarker Study in Alzheimer's Disease
NCT07142954 · tracked via the Priya Life Science Japan tracker
Condition(s) studied
Alzheimer Disease
Investigational drug(s) / intervention(s)
P-tau217 Test
P-tau217 Test: A plasma test measuring phosphorylated tau at Position 217 (P-tau217).
Study summary
Study AACU determines rates of cognitive worsening in participants within elevated and not elevated plasma P-tau217 cohorts.
Participation in AACU will last approximately 7 years.
Eligibility
Inclusion Criteria:
* The participant must self-report unimpaired cognition.
* The participant must have adequate literacy, vision, and hearing for neuropsychological assessments at the time of screening.
Exclusion Criteria:
* Have seen a doctor about memory concerns.
* Have a history or diagnosis of cognitive impairment, or significant other neurodegenerative disease that can affect cognition.
* Are currently enrolled or have previously participated in any Alzheimer's Disease (AD)-related study involving an investigational drug intervention.
* Are currently using or have previously used prescription medications for treatment of mild cognitive impairment (MCI) or dementia such as amyloid targeting therapy (that is, lecanemab, donanemab, aducanumab), cholinesterase inhibitors (for example, benzgalantamine, donepezil, galantamine, rivastigmine), and memantine.
Primary outcome measure(s)
- Time to Cognitive Worsening Within Cohorts as Measured by Cognitive Composite or Any of the Individual Composite Components — Baseline up to 7 years
Cognitive composite may consist of International Daily Symbol Substitution Test-Medicines (iDSSTm ), International Shopping List Test (ISLT), Continuous Paired Associate Learning Test (CPAL). Time to cognitive worsening is defined as a change in cognitive composite score or any of the individual composite components, from baseline at 2 consecutive visits.
Trial sites (4)
| Facility | City | Region | Status |
|---|---|---|---|
| Care Access - Houston | Houston | Texas | Recruiting |
| The University of Tokyo Hospital | Bunkyō City | Japan | Recruiting |
| Souseikai Sumida Hospital | Tokyo | Japan | Recruiting |
| Higashi Shinjuku Clinic | Tokyo | Japan | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07142954 on ClinicalTrials.gov ↗ ← All trials in Japan