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
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