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P-tau217 Test

Phase 3

Alzheimer Disease | Unknown | Neurology |Eli Lilly and Company|Last Updated: Jul 7, 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment3,400

FDA Designations

No designations recorded

Clinical trial landscape

P-tau217 Test · 1 trial · 1 indication

Phase 3 1
NCT07142954Epidemiology and Biomarker Study in Alzheimer's DiseaseAlzheimer Disease
RECRUITING3,400 Analytics
PHASE3RECRUITING
Epidemiology and Biomarker Study in Alzheimer's Disease
Alzheimer DiseaseUnlock trial analytics

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 to 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)

LOWJul 7, 2026NCT07142954lastUpdatePostDate: changed
LOWJul 7, 2026NCT07142954lastUpdatePostDate: changed

Frequently asked questions about P-tau217 Test

What is the P-tau217 Test used for in Alzheimer Disease?

The P-tau217 Test is a diagnostic biomarker test being studied for use in Alzheimer Disease. It is currently in Phase 3 clinical development as an investigational test. The test is being evaluated in a large epidemiology and biomarker study to assess its utility in the condition.

What does the P-tau217 Test target?

The P-tau217 Test targets phosphorylated tau at threonine 217, a specific form of tau protein associated with Alzheimer Disease pathology. This biomarker is measured to help identify or monitor the disease process. The test is being investigated for its diagnostic capabilities in Alzheimer Disease.

Who makes the P-tau217 Test?

The P-tau217 Test is being developed by Eli Lilly and Company, a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY. The company is conducting a Phase 3 clinical trial to evaluate the test's performance in Alzheimer Disease.

What phase is the P-tau217 Test in?

The P-tau217 Test is in Phase 3 clinical development. It is an investigational test and has not been approved by regulatory authorities. The ongoing Phase 3 trial is actively recruiting participants to evaluate the test in Alzheimer Disease.

What clinical trials is the P-tau217 Test in?

The P-tau217 Test is being evaluated in a single Phase 3 clinical trial with the identifier NCT07142954, titled 'Epidemiology and Biomarker Study in Alzheimer's Disease'. This recruiting study plans to enroll 3,400 participants aged 55 years and older in the United States and Japan.