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

Recruiting now · Not applicable

Conditions studied: Subjective Cognitive Impairment

In brief

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.

Key facts

Study ID

NCT07140744

Run by

Eli Lilly and Company

People needed

7000

Starts

2025-08-22

Expected to finish

2027-10-01

Last updated by the study team

2025-11-03

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

Where it is running

• SiteRx Virtual Site — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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