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Epidemiology and Biomarker Study in Alzheimer's Disease

NCT07142954 · Eli Lilly and Company
In plain English

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Official 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)
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.
Eligibility criteria
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 target: 3400 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-08-25
Estimated completion: 2033-07
Last updated: 2026-02-10
Interventions
Other: P-tau217 Test
Primary outcomes
  • Time to Cognitive Worsening Within Cohorts as Measured by Cognitive Composite or Any of the Individual Composite Components (Baseline up to 7 years)
Sponsor
Eli Lilly and Company · industry
Contacts & investigators
ContactTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · contact · LillyTrials@Lilly.com · 1-317-615-4559
ContactPhysicians interested in becoming principal investigators please contact · contact · clinical_inquiry_hub@lilly.com
InvestigatorCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) · study_director, Eli Lilly and Company
All locations (3)
Care Access - HoustonRecruiting
Houston, Texas, United States
The University of Tokyo HospitalRecruiting
Bunkyō City, Japan
Souseikai Sumida HospitalRecruiting
Tokyo, Japan
Epidemiology and Biomarker Study in Alzheimer's Disease · TrialPath