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RecruitingNCT07140744Updated Oct 7, 2026

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

An interventional study of P-tau217 and Standard of Care in Subjective Cognitive Impairment, sponsored by Eli Lilly and Company. Recruiting at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-10-07.

Sponsored by Eli Lilly and Company · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Aug 2025; still recruiting 1 year 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
7,000
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Subjective Cognitive Impairment

Keywords

  • Diagnostic utility
  • Blood biomarkers
  • Blood diagnostics
03

In context

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
7,000 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • Diagnostic testP-tau217

    Blood biomarker testing

  • OtherStandard of Care

    Standard of care

06

What researchers measure

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.

    Time frame: 6 Months

Secondary outcomes

  1. 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.

    Time frame: 6 and 12 Months

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

    Time frame: 6 and 12 Months

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

    Time frame: 6 and 12 Months

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

    Time frame: 6 and 12 Months

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

    Time frame: 6 and 12 Months

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

    Time frame: 6 and 12 Months

  7. Time from Cognitive Complaint to Date of Counseling Between the S/TCP Tested Group and the S/TCP Control Group

    Time frame: 6 and 12 Months

  8. Time from Cognitive Complaint to Date of Initiating AD Therapy Between the S/TCP Tested Group and the S/TCP Control Group

    Time frame: 6 and 12 Months

  9. Time from Cognitive Complaint to Date of Initiating Non-AD Therapy Between the S/TCP Tested Group and the S/TCP Control Group

    Time frame: 6 and 12 Months

  10. 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

    Time frame: 6 and 12 Months

07

Study locations

1 of 1 sites recruiting
  • SiteRx Virtual Site
    New York, New York 10013, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Sap, Csr

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date
1 update, last Oct 7, 2026
Show all 1 update
  1. Oct 7, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07140744
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
Aug 26, 2025
Start date
Aug 22, 2025
Primary completion
Oct 2027 (estimated)
Completion
Oct 2027 (estimated)
Last update
Oct 7, 2026

Study contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Contact
LillyTrials@Lilly.com
1-317-615-4559
Physicians interested in becoming principal investigators please contact
Contact
clinical_inquiry_hub@lilly.com
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)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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