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P-tau217 Blood Test for Cognitive Complaints

This study is looking at how a blood test called P-tau217 affects the early evaluation and management of people who are concerned about their memory or thinking (cognitive complaint). The study will compare how doctors manage patients when they have access to the P-tau217 blood test versus when they don't. Researchers want to see if using this blood test leads to more management actions, such as referrals or new treatments, within six months. You might be able to join if you are 50 years or older and have concerns about your cognitive function. The study aims to enroll 7000 participants, but its current recruitment status is unclear.

Study design
This interventional study plans to enroll 7000 participants. It compares a group receiving the P-tau217 blood test with a standard of care group.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured at 6 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07140744

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

Recruiting
NAAges 50+Interventional
Eli Lilly and Company
~7,000 participants
Updated 2025-11-03 on ClinicalTrials.gov
What's tested:P-tau217Standard of Care

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Difference in Proportion of Participants Between the Primary Care Physician (PCP) Tested Group and the PCP Control Group with at Least 1 Management Action
Measured over 6 Months

Conditions

Subjective Cognitive Impairment

Explore related trials

Severe Cognitive Impairments

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) · STUDY_DIRECTOR · Eli Lilly and Company

Who to contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
[email protected]
1-317-615-4559
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Primary care physician (PCPs): physicians such as family medicine practitioners and internists who do not specialize in neurological care.
Secondary care physicians (SCPs): physicians such as geriatricians or neurologists who see patients for specific reasons.
Tertiary care physicians (TCPs): specialty neurologists who focus on certain neurological conditions.
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 in a family practice or internist setting.
Group 2: SCPs and TCPs with experience diagnosing and treating patients with cognitive impairment and dementia.
Must be willing to review educational materials provided by the study sponsor, before enrolling patients.
Participants in the interventional group are eligible to be included in the study only 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 duration of the study and are willing to follow study procedures.
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, misplacing items, difficulty concentrating, or new challenges with problem solving.

Exclusion

In the 18 months prior to identification have prior or associated HCP-ordered referral 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's opinion could interfere with completion of the study or have a life expectancy of less than 1 year.
Has a known brain lesion, pathology, or prior alternative diagnosis that could explain the participant's clinical presentation.

What this trial measures

  • Difference in Proportion of Participants Between the Primary Care Physician (PCP) Tested Group and the PCP Control Group with at Least 1 Management Action6 Months

    Difference in proportion of participants with a least 1 management action, referral to Secondary or Tertiary Care Physician (S/TCP); counseling; Alzheimer's Disease (AD) drug therapy related to cognitive complaint, or Non-AD drug therapy related to cognitive complaint.