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NCT07142954PHASE3RecruitingAccepts Healthy Volunteers

Epidemiology and Biomarker Study in Alzheimer's Disease

Eli Lilly and Company

Start Date

8/25/2025

Completion Date

7/1/2033

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.

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.

Eligibility Criteria

Age Range: 55 years to 75 years

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.

Interventions

OTHER

P-tau217 Test

Interested in This Trial?

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Conditions

Alzheimer Disease

Locations

Care Access - Houston

Houston, Texas 77054

United States

The University of Tokyo Hospital

Bunkyō City, 113-8654

Japan

Souseikai Sumida Hospital

Tokyo, 130-0004

Japan

Higashi Shinjuku Clinic

Tokyo, 169-0072

Japan