Epidemiology and Biomarker Study in Alzheimer's Disease (ANCHOR-AD)

Lilly

Status and phase: Not yet enrolling; Phase 3

Conditions: Alzheimer Disease

Treatments: Other: P-tau217 Test

Study type: Interventional

Funder types: Industry

Identifiers

NCT07142954

27588

I5T-MC-AACU (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,400 estimated patients

Sex: All

Ages: 55 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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3,400 participants in 2 patient groups

Elevated Plasma P-tau217 Levels

Other group

Description:

Participants with known elevated plasma P-tau217 levels who are cognitively unimpaired at baseline per self-report.

Treatment:

Other: P-tau217 Test

Not-Elevated P-tau217 Levels

Other group

Description:

Participants with known not-elevated plasma P-tau217 levels who are cognitively unimpaired at baseline per self-report.

Treatment:

Other: P-tau217 Test