Using a p‑tau217 blood test to guide early evaluation and care for people with memory complaints
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
This study will test whether giving clinicians p‑tau217 blood test results changes how they manage patients over 50 who come in with memory or cognitive complaints.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 7000 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Eli Lilly and Company Industry-sponsored |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT07140744 on ClinicalTrials.gov |
What this trial studies
This interventional study compares usual care to a management approach that incorporates plasma p‑tau217 results for patients presenting with subjective cognitive complaints. Health-care providers are enrolled and placed in an interventional group (who review educational materials and receive p‑tau217 test results) or a control group providing standard of care. The main outcomes measure whether prespecified diagnostic or management actions differ between groups based on HCP decisions for patient participants. The sponsor is Eli Lilly and the study is conducted through a virtual site based in New York.
Who should consider this trial
Good fit: Ideal candidates are adults presenting with subjective cognitive impairment or new memory complaints, especially those seen in primary or specialty care settings.
Not a fit: Patients without cognitive or memory complaints, those with an already established explanation for their symptoms, or those with advanced dementia unlikely to benefit from early diagnostic clarification may not gain benefit.
Why it matters
Potential benefit: If successful, this approach could help clinicians make earlier or more accurate management decisions for people with memory complaints, potentially leading to faster diagnosis and better care planning.
How similar studies have performed: Research shows plasma p‑tau217 reliably tracks Alzheimer-type pathology and has strong diagnostic performance, but trials testing whether providing this biomarker to clinicians changes real-world management are limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
New York, New York
- SiteRx Virtual Site — New York, New York, United States (Recruiting)
Study contacts
- Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
- Email: LillyTrials@Lilly.com
- Phone: 1-317-615-4559
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.