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

A Prospective Diagnostic Study Evaluating the Impact of P-tau217 Blood Biomarker Testing on Early Evaluation and Management of Patients Presenting With Cognitive Complaint in Primary and Secondary/Tertiary Care

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.

Study Overview

• Status: Recruiting
• Conditions: Subjective Cognitive Impairment
• Intervention / Treatment: Other: Standard of Care; Diagnostic test: P-tau217

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 7000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or; Phone Number: 1-317-615-4559; Email: LillyTrials@Lilly.com
• Study Contact Backup: Name: Physicians interested in becoming principal investigators please contact; Email: clinical_inquiry_hub@lilly.com

Study Locations

• United States
  • New York
    • New York, New York, United States, 10013
      • Recruiting
      • SiteRx Virtual Site
      • Contact: Ira Goodman; Phone Number: 888-397-0072; Email: ira@site.siterx.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Diagnostic test: P-tau217; Blood biomarker testing
Other: 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.	Other: Standard of Care; Standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in Proportion of Participants Between the S/TCP Tested Group and the S/TCP Control Group with at Least 1 Management Action	Difference in proportion of participants with a least 1 management action, referral to S/TCP; counseling; AD drug therapy related to cognitive complaint, or Non-AD drug therapy related to cognitive complaint.	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
Time from Cognitive Complaint to Date of Referral to a S/TCP Between the S/TCP Tested Group and the S/TCP Control Group:		6 and 12 Months
Time from Cognitive Complaint to Date of Counseling Between the S/TCP Tested Group and the S/TCP Control Group		6 and 12 Months
Time from Cognitive Complaint to Date of Initiating AD Therapy Between the S/TCP Tested Group and the S/TCP Control Group		6 and 12 Months
Time from Cognitive Complaint to Date of Initiating Non-AD Therapy Between the S/TCP Tested Group and the S/TCP Control Group		6 and 12 Months
Difference in Proportion of Participants with a Documented Alzheimer's Disease-Specific International Classification of Diseases (ICD) - 10 Code Between the S/TCP Tested Group and the S/TCP Control Group		6 and 12 Months

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: 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 record dates

Study Major Dates

• Study Start (Actual): August 22, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: August 22, 2025
• First Submitted That Met QC Criteria: August 22, 2025
• First Posted (Estimated): August 26, 2025

Study Record Updates

• Last Update Posted (Estimated): November 3, 2025
• Last Update Submitted That Met QC Criteria: October 30, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Blood biomarkers; Diagnostic utility; Blood diagnostics
• Additional Relevant MeSH Terms: Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: 28782; J4Y-MC-S003 (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
• IPD Sharing 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.
• IPD Sharing Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No