Subjective Cognitive ImpairmentNCT07140744
A Study Evaluating the Impact of P-tau217 Blood Biomarker Testing on Early Evaluation and Management of Patients Presenting With Cognitive Complaint
A study testing P-tau217 in people with Subjective Cognitive Impairment, run by Eli Lilly and Company at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Subjective Cognitive Impairment
- What is being tested?
- P-tau217
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,000 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Aug 2025to Oct 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
United States1 site, 1 recruiting
- Recruiting
SiteRx Virtual Site
New York, New York, 10013
Ira Goodman, 888-397-0072, ira@site.siterx.com
About this study
Official title: 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.
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.
- Conditions
- Subjective Cognitive Impairment
- Being tested
- P-tau217, Standard of Care
- Keywords
- Diagnostic utility, Blood biomarkers, Blood diagnostics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P-tau217Diagnostic test
Blood biomarker testing
Standard of CareOther
Standard of care
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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:
Measured: 6 and 12 Months
Time from Cognitive Complaint to Date of Counseling Between the PCP Tested Group and the PCP Control Group
Measured: 6 and 12 Months
Time from Cognitive Complaint to Date of Initiating AD Therapy Between the PCP Tested Group and the PCP Control Group
Measured: 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
Measured: 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:
Measured: 6 and 12 Months
Time from Cognitive Complaint to Date of Counseling Between the S/TCP Tested Group and the S/TCP Control Group
Measured: 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
Measured: 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
Measured: 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
Measured: 6 and 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start22 Aug 2025
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subjective Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07140744
- Sponsor's protocol ID
- 28782
- Other IDs
- J4Y-MC-S003
- Status last verified
- Oct 2026
- First submitted
- 22 Aug 2025
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.