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

NCT07140744 | Recruiting

• 2 other identifiers: 28782J4Y-MC-S003
• Study Type: interventional
• Target: 7,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Subjective Cognitive Impairment

Keywords

Diagnostic utility; Blood biomarkers; Blood diagnostics

Outcome Measures

Primary Outcomes (1)

• Difference in Proportion of Participants Between the Primary Care Physician (PCP) Tested Group and the PCP Control Group with at Least 1 Management Action

  Difference in proportion of participants with a least 1 management action, referral to Secondary or Tertiary Care Physician (S/TCP); counseling; Alzheimer's Disease (AD) drug therapy related to cognitive complaint, or Non-AD drug therapy related to cognitive complaint.

  6 Months

Secondary Outcomes (10)

• Difference in Proportion of Participants Between the S/TCP Tested Group and the S/TCP Control Group with at Least 1 Management Action

  6 and 12 Months

• Time from Cognitive Complaint to Date of Referral to a S/TCP Between the PCP Tested Group and the PCP Control Group:

  6 and 12 Months

• Time from Cognitive Complaint to Date of Counseling Between the PCP Tested Group and the PCP Control Group

  6 and 12 Months

• Time from Cognitive Complaint to Date of Initiating AD Therapy Between the PCP Tested Group and the PCP Control Group

  6 and 12 Months

• Time from Cognitive Complaint to Date of Initiating Non-AD Therapy Between the PCP Tested Group and the PCP Control Group

  6 and 12 Months

Study Arms (2)

Interventional Group

OTHER

Stratified by Primary Care Physician (PCP) versus Secondary/Tertiary Physician (S/TCP) Patient participants in the interventional group will undergo P-tau217 testing.

Diagnostic Test: P-tau217

Standard of Care Group

OTHER

Stratified by PCP versus S/TCP Patient participants in the standard of care group (SOC) will not undergo sponsor-provided P-tau217 testing.

Other: Standard of Care

Interventions

P-tau217 DIAGNOSTIC_TEST

Blood biomarker testing

Interventional Group

Standard of Care OTHER

Standard of care

Standard of Care Group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

SiteRx Virtual Site

New York, New York, 10013, United States

RECRUITING

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Central Study Contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

1-317-615-4559; LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2025
• First Posted: August 26, 2025
• Study Start: August 22, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: November 3, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

US (1)