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NCT07140744
A Study Evaluating the Impact of P-tau217 Blood Biomarker Testing on Early Evaluation and Management of Patients Presenting With Cognitive Complaint
Conditions: Subjective Cognitive Impairment
Sex: All
Ages: 50 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 7000
Sponsor: Eli Lilly and Company
Location: SiteRx Virtual Site New York New York
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.
Source: ClinicalTrials.gov (NCT07140744). StuddyBuddy aggregates publicly available trial information.