Using a p‑tau217 blood test to guide early evaluation and care for people with memory complaints

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.