Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07142954

Epidemiology and Biomarker Study in Alzheimer's Disease

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

55 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The University of Tokyo Hospital, Bunkyō City, Japan

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

P-tau217 Test

Other

A plasma test measuring phosphorylated tau at Position 217 (P-tau217).

Primary outcomes

  1. Time to Cognitive Worsening Within Cohorts as Measured by Cognitive Composite or Any of the Individual Composite Components

    Time frame: 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.

Secondary outcomes

  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

    Time frame: Baseline up to 7 years

    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)

    Time frame: Baseline up to 7 years

  3. Time to Cognitive Worsening within Cohorts as Measured by Montreal Cognitive Assessment XpressO version (XpressO)

    Time frame: Baseline up to 7 years

  4. Time to Cognitive Worsening Between Groups as Measured by CFI

    Time frame: Baseline up to 7 years

  5. Time to Cognitive Worsening Between Groups as Measured by XpressO

    Time frame: Baseline up to 7 years

  6. Change from Baseline Within Not-Elevated and Elevated P-tau217 Groups as Measured by Cognitive Composite Score

    Time frame: Baseline, Year 7

  7. Change from Baseline Within Not-Elevated and Elevated P-tau217 Groups as Measured by ISLT

    Time frame: Baseline, Year 7

  8. Change from Baseline Within Not-Elevated and Elevated P-tau217 Groups as Measured by iDSSTm

    Time frame: Baseline, Year 7

  9. Change from Baseline Between Not-Elevated and Elevated P-tau217 Groups as Measured by Cognitive Composite Score

    Time frame: Baseline, Year 7

  10. Change from Baseline Between Not-Elevated and Elevated P-tau217 Groups as Measured by ISLT

    Time frame: Baseline, Year 7

  11. Change from Baseline Between Not-Elevated and Elevated P-tau217 Groups as Measured by iDSSTm

    Time frame: Baseline, Year 7

  12. Weighted Proportion of Participants with Elevated Plasma P-tau217 Levels in US and Japan with Unimpaired Cognition at Baseline

    Time frame: Baseline

Study contacts

Contact information is provided by the study sponsor or research team.

Physicians interested in becoming principal investigators please contact

CONTACT

[email protected]

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

CONTACT

[email protected]

1-317-615-4559

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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)

Acronym: ANCHOR-AD

Important dates

Study start
2025
Primary completion
2033
Study completion
2033
First posted
Aug 27, 2025
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.