NCT07140744 A Study Evaluating the Impact of P-tau217 Blood Biomarker Testing on Early Evaluation and Management of Patients Presenting With Cognitive Complaint

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 7,000 participants in total. It began in 2025-08-22 with a primary completion date of 2027-10.

Brief 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 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.

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