Tracking blood P-tau217 and early cognitive change in people without memory symptoms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a non-drug, longitudinal program that will enroll about 3,400 adults who self-report unimpaired cognition and follow them for roughly seven years. Participants will have annual plasma P-tau217 blood tests and periodic neuropsychological assessments to compare cognitive trajectories in those with elevated versus not elevated P-tau217. The primary approach is to measure rates of cognitive worsening between the two biomarker-defined cohorts. No investigational drugs are given; the intervention is regular biomarker monitoring and observational follow-up.

Why it matters

Who can join: the full rules

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.

Where it's running

• Care Access - Houston
  Houston, Texas, United States Recruiting
• The University of Tokyo Hospital
  Bunkyō City, Japan Recruiting
• Souseikai Sumida Hospital
  Tokyo, Japan Recruiting
• Higashi Shinjuku Clinic
  Tokyo, Japan Recruiting

Study contacts

• Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
• Email: LillyTrials@Lilly.com
• Phone: 1-317-615-4559

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.