Epidemiology and Biomarker Study in Alzheimer's Disease

Phase 3RecruitingNCT07142954

Eli Lilly and Company3,400 enrolled

Overview

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.

Study AACU is a non-drug interventional study. The intervention is annual plasma P-tau217 testing. Enrollment is anticipated to be approximately 3400 participants.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

3,400

Conditions

Alzheimer Disease

Interventions

P-tau217 TestOTHER

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

Eligibility

Sex: ALLMin age: 55 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (3)

Care Access - Houston

Houston, Texas, United States

RECRUITING

The University of Tokyo Hospital

Bunkyō City, Japan

RECRUITING

Souseikai Sumida Hospital

Tokyo, Japan

RECRUITING

Outcomes

Primary Outcomes

Time to Cognitive Worsening Within Cohorts as Measured by Cognitive Composite or Any of the Individual Composite Components

Cognitive composite may consist of International Daily Symbol Substitution Test-Medicines (iDSSTm ), International Shopping List Test (ISLT), Continuous Paired Associate Learning Test (CPAL). Time to cognitive worsening is defined as a change in cognitive composite score or any of the individual composite components, from baseline at 2 consecutive visits.