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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

7000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-22

Study Completion Date

2027-10-31

Brief Summary

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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.

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Detailed Description

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There are two types of participants in this study, HCP participants and patient participants. Outcome measures relate to the HCP management of patient participants.

Conditions

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Subjective Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Interventional Group

Stratified by Primary Care Physician (PCP) versus Secondary/Tertiary Physician (S/TCP)

Patient participants in the interventional group will undergo P-tau217 testing.

Group Type OTHER

P-tau217

Intervention Type DIAGNOSTIC_TEST

Blood biomarker testing

Standard of Care Group

Stratified by PCP versus S/TCP

Patient participants in the standard of care group (SOC) will not undergo sponsor-provided P-tau217 testing.

Group Type OTHER

Standard of Care

Intervention Type OTHER

Standard of care

Interventions

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P-tau217

Blood biomarker testing

Intervention Type DIAGNOSTIC_TEST

Standard of Care

Standard of care

Intervention Type OTHER

Eligibility Criteria

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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.

* 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.

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.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No