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

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

Recruiting
50 years and older
All
Phase N/A

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Overview

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.

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.

Eligibility

Inclusion Criteria:

Health Care Provider (HCP) Definitions

  • 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 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 in a family practice or internist setting.
    • Group 2: SCPs and TCPs with experience diagnosing and treating patients with cognitive 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 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.

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, misplacing items, difficulty concentrating, or new challenges with problem solving.

Patient Participant Exclusion Criteria:

  • 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.

Study details
    Subjective Cognitive Impairment

NCT07140744

Eli Lilly and Company

1 February 2026

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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