NCT07140744RecruitingNot Applicable
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
Eli Lilly and Company2 sites in 1 country7,000 target enrollmentStarted: August 22, 2025Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Eli Lilly and Company
- Enrollment
- 7,000
- Locations
- 2
- Primary Endpoint
- Difference in Proportion of Participants Between the Primary Care Physician (PCP) Tested Group and the PCP Control Group with at Least 1 Management Action
Study Overview
Brief 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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
- •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.
Outcomes
Primary Outcomes
Difference in Proportion of Participants Between the Primary Care Physician (PCP) Tested Group and the PCP Control Group with at Least 1 Management Action
Time Frame: 6 Months
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.
Secondary Outcomes
- Time from Cognitive Complaint to Date of Counseling Between the PCP Tested Group and the PCP Control Group(6 and 12 Months)
- Difference in Proportion of Participants Between the S/TCP Tested Group and the S/TCP Control Group with at Least 1 Management Action(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:(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:(6 and 12 Months)
- Time from Cognitive Complaint to Date of Initiating AD Therapy Between the PCP Tested Group and the PCP Control Group(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(6 and 12 Months)
- Time from Cognitive Complaint to Date of Counseling Between the S/TCP Tested Group and the S/TCP Control Group(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(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(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(6 and 12 Months)
Investigators
Study Sites (2)
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