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

Lilly

Status: Enrolling

Conditions: Subjective Cognitive Impairment

Treatments: Diagnostic Test: P-tau217; Other: Standard of Care

Study type: Interventional

Funder types: Industry

Identifiers

NCT07140744

J4Y-MC-S003 (Other Identifier)

28782

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7,000 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion and 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

7,000 participants in 2 patient groups

Interventional Group

Other group

Description:

Stratified by Primary Care Physician (PCP) versus Secondary/Tertiary Physician (S/TCP) Patient participants in the interventional group will undergo P-tau217 testing.

Treatment:

Diagnostic Test: P-tau217

Standard of Care Group

Other group

Description:

Stratified by PCP versus S/TCP Patient participants in the standard of care group (SOC) will not undergo sponsor-provided P-tau217 testing.

Treatment:

Other: Standard of Care