Epidemiology and Biomarker Study in Alzheimer's Disease

Purpose

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.

Condition

  • Alzheimer Disease

Eligibility

Eligible Ages
Between 55 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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

Phase
Phase 3
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Single Group Assignment
Primary Purpose
Other
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Other
Elevated Plasma P-tau217 Levels 		Participants with known elevated plasma P-tau217 levels who are cognitively unimpaired at baseline per self-report.
  • Other: P-tau217 Test
    A plasma test measuring phosphorylated tau at Position 217 (P-tau217).
Other
Not-Elevated P-tau217 Levels 		Participants with known not-elevated plasma P-tau217 levels who are cognitively unimpaired at baseline per self-report.
  • Other: P-tau217 Test
    A plasma test measuring phosphorylated tau at Position 217 (P-tau217).

Recruiting Locations

Care Access - Houston
Houston, Texas 77054
Contact:
877-791-0656

More Details

Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
LillyTrials@Lilly.com

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.