Epidemiology and Biomarker Study in Alzheimer's Disease (ANCHOR-AD)

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)

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.

Study Overview

• Status: Recruiting
• Conditions: Alzheimer Disease
• Intervention / Treatment: Other: P-tau217 Test

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 3400
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or; Phone Number: 1-317-615-4559; Email: LillyTrials@Lilly.com
• Study Contact Backup: Name: Physicians interested in becoming principal investigators please contact; Email: clinical_inquiry_hub@lilly.com

Study Locations

• Japan
  • Bunkyō City, Japan, 113-8654
    • Recruiting
    • The University of Tokyo Hospital
    • Contact: Phone Number: 81120023812
    • Principal Investigator: Yoshiki Niimi
  • Tokyo, Japan, 169-0072
    • Not yet recruiting
    • Higashi Shinjuku Clinic
    • Contact: Phone Number: 81120023812
    • Principal Investigator: Hiroaki Kondo
  • Tokyo, Japan, 130-0004
    • Recruiting
    • SOUSEIKAI Sumida Hospital
    • Contact: Phone Number: 81120023812
    • Principal Investigator: Takuma Yonemura
• United States
  • Texas
    • Houston, Texas, United States, 77054
      • Recruiting
      • Care Access - Houston
      • Principal Investigator: Ali Bajwa
      • Contact: Phone Number: 877-791-0656

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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).
Other: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline up to 7 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline up to 7 years
Time to Cognitive Worsening within Cohorts as Measured by Cognitive Function Index (CFI)		Baseline up to 7 years
Time to Cognitive Worsening within Cohorts as Measured by Montreal Cognitive Assessment XpressO version (XpressO)		Baseline up to 7 years
Time to Cognitive Worsening Between Groups as Measured by CFI		Baseline up to 7 years
Time to Cognitive Worsening Between Groups as Measured by XpressO		Baseline up to 7 years
Change from Baseline Within Not-Elevated and Elevated P-tau217 Groups as Measured by Cognitive Composite Score		Baseline, Year 7
Change from Baseline Within Not-Elevated and Elevated P-tau217 Groups as Measured by ISLT		Baseline, Year 7
Change from Baseline Within Not-Elevated and Elevated P-tau217 Groups as Measured by iDSSTm		Baseline, Year 7
Change from Baseline Between Not-Elevated and Elevated P-tau217 Groups as Measured by Cognitive Composite Score		Baseline, Year 7
Change from Baseline Between Not-Elevated and Elevated P-tau217 Groups as Measured by ISLT		Baseline, Year 7
Change from Baseline Between Not-Elevated and Elevated P-tau217 Groups as Measured by iDSSTm		Baseline, Year 7
Weighted Proportion of Participants with Elevated Plasma P-tau217 Levels in US and Japan with Unimpaired Cognition at Baseline		Baseline

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• 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

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2025
• Primary Completion (Estimated): July 1, 2033
• Study Completion (Estimated): July 1, 2033

Study Registration Dates

• First Submitted: August 20, 2025
• First Submitted That Met QC Criteria: August 20, 2025
• First Posted (Actual): August 27, 2025

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Primary Prevention; Preclinical Alzheimer's Disease
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Alzheimer Disease
• Other Study ID Numbers: 27588; I5T-MC-AACU (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No