Recruiting
Phase 3

Cognitive Worsening

Sponsor:

Eli Lilly and Company

Code:

NCT07142954

Conditions

Alzheimer Disease

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Accepted

Interventions

P-tau217 Test

Study Details

Brief summary:

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.

Conditions

Alzheimer Disease

Study ID

NCT07142954

Start date

Aug 25, 2025

Status verified date

Jul, 2026

Completion date

Jul, 2033

Anticipated

Primary completion date

Jul, 2033

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

3400 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: Elevated Plasma P-tau217 Levels

Participants with known elevated plasma P-tau217 levels who are cognitively unimpaired at baseline per self-report.

other: Not-Elevated P-tau217 Levels

Participants with known not-elevated plasma P-tau217 levels who are cognitively unimpaired at baseline per self-report.

Interventions

P-tau217 Test

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

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

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

1-317-615-4559LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

Care Access - Houston

Recruiting

Houston, Texas, United States, 77054

Contacts

877-791-0656

Principal Investigator:

Ali Bajwa

More Information

Sponsor

Eli Lilly and Company

Last update posted

Jul 7, 2026

Last verified

Jul, 2026

Keywords

  • Preclinical Alzheimer's Disease
  • Primary Prevention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-07-07.