Epidemiology and Biomarker Study in Alzheimer's Disease

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified April 2026 by Eli Lilly and Company
Sponsor
Eli Lilly and Company
Information Provided by (Responsible Party)
Eli Lilly and Company
Clinicaltrials.gov Identifier
NCT07142954
Other Study ID Numbers:
27588
First Submitted
August 19, 2025
First Posted
August 26, 2025
Last Update Posted
May 13, 2026
Last Verified
April 2026

ClinicalTrials.gov processed this data on May 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Study AACU is a non-drug interventional study. The intervention is annual plasma P-tau217 testing. Enrollment is anticipated to be approximately 3400 participants.

Condition or DiseaseIntervention/Treatment
Alzheimer Disease
Other: P-tau217 TestOther: P-tau217 Test

Study Design

Study TypeInterventional
Actual Enrollment3400 participants
Design AllocationNon-Randomized
Interventional ModelSingle Group Assignment
MaskingNone (Open Label)
Primary PurposeOther
Official TitleA 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)
Study Start DateAugust 24, 2025
Actual Primary Completion Date7yrs 1mo from now
Actual Study Completion Date7yrs 1mo from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Elevated Plasma P-tau217 Levels
Participants with known elevated plasma P-tau217 levels who are cognitively unimpaired at baseline per self-report.
Other: P-tau217 Test
A plasma test measuring phosphorylated tau at Position 217 (P-tau217).
Not-Elevated P-tau217 Levels
Participants with known not-elevated plasma P-tau217 levels who are cognitively unimpaired at baseline per self-report.
Other: P-tau217 Test
A plasma test measuring phosphorylated tau at Position 217 (P-tau217).

Outcome Measures

Primary Outcome Measures
  1. Time to Cognitive Worsening Within Cohorts as Measured by Cognitive Composite or Any of the Individual Composite Components
    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.
Secondary Outcome Measures
  1. Time to Cognitive Worsening Between Groups (Participants Within Elevated and Not-Elevated Plasma P-Tau217) as Measured by Cognitive Composite or Any of the Individual Composite Components
    Cognitive composite may consist of iDSSTm, ISLT, and 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.
  2. Time to Cognitive Worsening within Cohorts as Measured by Cognitive Function Index (CFI)
  3. Time to Cognitive Worsening within Cohorts as Measured by Montreal Cognitive Assessment XpressO version (XpressO)
  4. Time to Cognitive Worsening Between Groups as Measured by CFI
  5. Time to Cognitive Worsening Between Groups as Measured by XpressO
  6. Change from Baseline Within Not-Elevated and Elevated P-tau217 Groups as Measured by Cognitive Composite Score
  7. Change from Baseline Within Not-Elevated and Elevated P-tau217 Groups as Measured by ISLT
  8. Change from Baseline Within Not-Elevated and Elevated P-tau217 Groups as Measured by iDSSTm
  9. Change from Baseline Between Not-Elevated and Elevated P-tau217 Groups as Measured by Cognitive Composite Score
  10. Change from Baseline Between Not-Elevated and Elevated P-tau217 Groups as Measured by ISLT
  11. Change from Baseline Between Not-Elevated and Elevated P-tau217 Groups as Measured by iDSSTm
  12. Weighted Proportion of Participants with Elevated Plasma P-tau217 Levels in US and Japan with Unimpaired Cognition at Baseline

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersYes
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.

Contacts and Locations

Sponsors and CollaboratorsEli Lilly and Company
Locations
Care Access - Houston | Houston Texas, United States, 77054The University of Tokyo Hospital | Bunkyō City , Japan, 113-8654Souseikai Sumida Hospital | Tokyo , Japan, 130-0004Higashi Shinjuku Clinic | Tokyo , Japan, 169-0072
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company