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

A Longitudinal, Prospective Epidemiology Study in Alzheimer's Disease: Assessing Neurocognitive and Biomarker Changes and Health Outcomes in Individuals at Risk for Symptoms of Alzheimer's Disease (ANCHOR-AD)

This project will test whether yearly blood P-tau217 tests can identify people who currently have no memory symptoms but later show cognitive worsening.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3400 (estimated)
• Ages: 55 Years to 75 Years
• Sex: All
• Sponsor: Eli Lilly and Company (Industry-sponsored)
• Drugs / interventions: lecanemab, donanemab, aducanumab
• Locations: 3 sites (Houston, Texas and 2 other locations)
• Trial ID: NCT07142954 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults who self-report unimpaired cognition, have adequate literacy, vision, and hearing for testing, have not seen a doctor for memory concerns, have no diagnosis of cognitive impairment or other major neurodegenerative disease, and have not used prescription dementia drugs or joined AD drug trials.

Not a fit: People who already have diagnosed cognitive impairment or memory concerns, who have significant neurodegenerative disease, or who have used prescription dementia drugs or participated in AD drug intervention trials are unlikely to benefit from this program.

Why it matters

Potential benefit: If successful, the approach could allow earlier identification of people at higher risk of cognitive decline using a simple blood test, enabling earlier monitoring or prevention efforts.

How similar studies have performed: Prior research has shown plasma P-tau217 correlates with Alzheimer's pathology and can predict progression, but large, long-term preclinical cohorts using annual P-tau217 monitoring remain limited.

Eligibility criteria

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 this trial is running

Houston, Texas and 2 other locations

• Care Access - Houston — Houston, Texas, United States (Recruiting)
• The University of Tokyo Hospital — Bunkyō City, Japan (Recruiting)
• Souseikai Sumida Hospital — Tokyo, Japan (Recruiting)

Study contacts

• Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

Conditions Alzheimer Disease; Preclinical Alzheimer's Disease; Primary Prevention