Status:
RECRUITING
Epidemiology and Biomarker Study in Alzheimer's Disease
Lead Sponsor:
Eli Lilly and Company
Conditions:
Alzheimer Disease
Eligibility:
All Genders
55-75 years
Phase:
PHASE3
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.
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
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 25 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2033
Estimated Enrollment :
3400 Patients enrolled
Trial Details
Trial ID
NCT07142954
Start Date
August 25 2025
End Date
July 1 2033
Last Update
October 21 2025
Active Locations (3)
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1
Care Access - Houston
Houston, Texas, United States, 77054
2
The University of Tokyo Hospital
Bunkyō City, Japan, 113-8654
3
Souseikai Sumida Hospital
Tokyo, Japan, 130-0004