A Study Evaluating the Impact of P-tau217 Blood Biomarker Testing on Early Evaluation and Management of Patients Presenting With Cognitive Complaint

Last updated: October 30, 2025
Sponsor: Eli Lilly and Company
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

P-tau217

Standard of Care

Clinical Study ID

NCT07140744
28782
J4Y-MC-S003
  • Ages > 50
  • All Genders

Study Summary

The purpose of the study is to measure the difference in the proportion of participants with prespecified patient management actions between a tested interventional group and a control group.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Health Care Provider (HCP) Definitions

  • Primary care physician (PCPs): physicians such as family medicine practitioners andinternists who do not specialize in neurological care.

  • Secondary care physicians (SCPs): physicians such as geriatricians or neurologistswho see patients for specific reasons.

  • Tertiary care physicians (TCPs): specialty neurologists who focus on certainneurological conditions.

HCP Participant Selection Criteria

  • HCP inclusion criterion for each category of HCP is as follows:

  • Group 1: PCPs who routinely evaluate and manage patients over the age of 50 ina family practice or internist setting.

  • Group 2: SCPs and TCPs with experience diagnosing and treating patients withcognitive impairment and dementia.

Additional inclusion criteria applying to HCPs in the interventional group:

  • Must be willing to review educational materials provided by the study sponsor,before enrolling patients.

Patient Participant Criteria

  • Participants in the interventional group are eligible to be included in the studyonly if all the following criteria apply:

  • Are capable of giving, and have given, signed informed consent.

  • Have venous access sufficient to allow the protocol-required blood sampling.

  • Are reliable, willing, and able to make themselves available for the durationof the study and are willing to follow study procedures.

Disease-specific Characteristics

  • Present to the HCP with 1 or more subjective cognitive impairment complaints (SCIC)in the 4 weeks prior to identification: for example, worsening of memory, misplacingitems, difficulty concentrating, or new challenges with problem solving.

Exclusion

Patient Participant Exclusion Criteria:

  • In the 18 months prior to identification have prior or associated HCP-orderedreferral or prior prescription of drug therapies, for the SCIC

  • Participants with previous amyloid- or tau-specific tests, defined as

  • Amyloid position emission tomography (PET)

  • Tau PET

  • Cerebral spinal fluid (CSF) tests for amyloid beta (Aβ) and/or tau biomarkers,or

  • Blood tests for Aβ and/or tau biomarkers

  • Has a current serious or unstable illness that in the enrolling investigator'sopinion could interfere with completion of the study or have a life expectancy ofless than 1 year.

  • Has a known brain lesion, pathology, or prior alternative diagnosis that couldexplain the participant's clinical presentation.

Study Design

Total Participants: 7000
Treatment Group(s): 2
Primary Treatment: P-tau217
Phase:
Study Start date:
August 22, 2025
Estimated Completion Date:
October 31, 2027

Study Description

There are two types of participants in this study, HCP participants and patient participants. Outcome measures relate to the HCP management of patient participants.

Connect with a study center

  • SiteRx Virtual Site

    New York 5128581, New York 5128638 10013
    United States

    Active - Recruiting

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