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)
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Eli Lilly and Company
- Enrollment
- 3,400
- Locations
- 4
- Primary Endpoint
- Time to Cognitive Worsening Within Cohorts as Measured by Cognitive Composite or Any of the Individual Composite Components
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 55 Years to 75 Years (Adult, Older Adult)
- 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.
Arms & Interventions
Elevated Plasma P-tau217 Levels
Participants with known elevated plasma P-tau217 levels who are cognitively unimpaired at baseline per self-report.
Intervention: P-tau217 Test (Other)
Not-Elevated P-tau217 Levels
Participants with known not-elevated plasma P-tau217 levels who are cognitively unimpaired at baseline per self-report.
Intervention: P-tau217 Test (Other)
Outcomes
Primary Outcomes
Time to Cognitive Worsening Within Cohorts as Measured by Cognitive Composite or Any of the Individual Composite Components
Time Frame: Baseline up to 7 years
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.
Secondary Outcomes
- Time to Cognitive Worsening Between Groups (Participants Within Elevated and Not-Elevated Plasma P-Tau217) as Measured by Cognitive Composite or Any of the Individual Composite Components(Baseline up to 7 years)
- Time to Cognitive Worsening within Cohorts as Measured by Montreal Cognitive Assessment XpressO version (XpressO)(Baseline up to 7 years)
- Change from Baseline Within Not-Elevated and Elevated P-tau217 Groups as Measured by Cognitive Composite Score(Baseline, Year 7)
- Time to Cognitive Worsening within Cohorts as Measured by Cognitive Function Index (CFI)(Baseline up to 7 years)
- Time to Cognitive Worsening Between Groups as Measured by CFI(Baseline up to 7 years)
- Time to Cognitive Worsening Between Groups as Measured by XpressO(Baseline up to 7 years)
- Change from Baseline Within Not-Elevated and Elevated P-tau217 Groups as Measured by iDSSTm(Baseline, Year 7)
- Change from Baseline Between Not-Elevated and Elevated P-tau217 Groups as Measured by Cognitive Composite Score(Baseline, Year 7)
- Change from Baseline Between Not-Elevated and Elevated P-tau217 Groups as Measured by ISLT(Baseline, Year 7)
- Change from Baseline Between Not-Elevated and Elevated P-tau217 Groups as Measured by iDSSTm(Baseline, Year 7)
- Change from Baseline Within Not-Elevated and Elevated P-tau217 Groups as Measured by ISLT(Baseline, Year 7)
- Weighted Proportion of Participants with Elevated Plasma P-tau217 Levels in US and Japan with Unimpaired Cognition at Baseline(Baseline)