A Phase 3 interventional study of P-tau217 Test in Alzheimer Disease, sponsored by Eli Lilly and Company. Recruiting at 4 sites in 2 countries. Open to participants aged 55 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-07.
Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Other
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.
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's planned enrollment of 3,400 is above the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.
Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants with known elevated plasma P-tau217 levels who are cognitively unimpaired at baseline per self-report.
Other: P-tau217 Test
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).
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.
Time frame: Baseline up to 7 years
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
Cognitive composite may consist of iDSSTm, ISLT, and 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.
Time frame: Baseline up to 7 years
Time to Cognitive Worsening within Cohorts as Measured by Cognitive Function Index (CFI)
Time frame: Baseline up to 7 years
Time to Cognitive Worsening within Cohorts as Measured by Montreal Cognitive Assessment XpressO version (XpressO)
Time frame: Baseline up to 7 years
Time to Cognitive Worsening Between Groups as Measured by CFI
Time frame: Baseline up to 7 years
Time to Cognitive Worsening Between Groups as Measured by XpressO
Time frame: Baseline up to 7 years
Change from Baseline Within Not-Elevated and Elevated P-tau217 Groups as Measured by Cognitive Composite Score
Time frame: Baseline, Year 7
Change from Baseline Within Not-Elevated and Elevated P-tau217 Groups as Measured by ISLT
Time frame: Baseline, Year 7
Change from Baseline Within Not-Elevated and Elevated P-tau217 Groups as Measured by iDSSTm
Time frame: Baseline, Year 7
Change from Baseline Between Not-Elevated and Elevated P-tau217 Groups as Measured by Cognitive Composite Score
Time frame: Baseline, Year 7
Change from Baseline Between Not-Elevated and Elevated P-tau217 Groups as Measured by ISLT
Time frame: Baseline, Year 7
Change from Baseline Between Not-Elevated and Elevated P-tau217 Groups as Measured by iDSSTm
Time frame: Baseline, Year 7
Weighted Proportion of Participants with Elevated Plasma P-tau217 Levels in US and Japan with Unimpaired Cognition at Baseline
Time frame: Baseline
Plan to share: No
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