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P-tau217 Test

Phase 3

Alzheimer Disease | Unknown | Neurology |Eli Lilly and Company|Last Updated: May 14, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment3,400
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07142954Epidemiology and Biomarker Study in Alzheimer's DiseasePHASE3 RECRUITING 3,400Aug 25, 2025Jul 1, 2033May 14, 20264 United States, Japan
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Study Endpoints
Primary Endpoints
Time to Cognitive Worsening Within Cohorts as Measured by Cognitive Composite or Any of the Individual Composite Components
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 Endpoints
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 Cognitive Function Index (CFI)
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
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeOTHER
Treatment Arms
ArmTypeDescription
Elevated Plasma P-tau217 LevelsOTHERParticipants with known elevated plasma P-tau217 levels who are cognitively unimpaired at baseline per self-report.
Not-Elevated P-tau217 LevelsOTHERParticipants with known not-elevated plasma P-tau217 levels who are cognitively unimpaired at baseline per self-report.
Interventions
NameTypeDescription
P-tau217 TestOTHERA plasma test measuring phosphorylated tau at Position 217 (P-tau217).
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Eligibility Criteria
Age Range55 Years — 75 Years
SexALL
Healthy VolunteersYes
Study Sites4

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 diagnosi...

Countries:United StatesJapan
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07142954primaryCompletionDate: changed
LOWMay 24, 2026NCT07142954studyFirstPostDate: changed