A Study Evaluating the Impact of P-tau217 Blood Biomarker Testing on Early Evaluation and Managem… (NCT07140744) | Clinical Trial Compass
RecruitingNot Applicable
A Study Evaluating the Impact of P-tau217 Blood Biomarker Testing on Early Evaluation and Management of Patients Presenting With Cognitive Complaint
United States7,000 participantsStarted 2025-08-22
Plain-language 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.
Who can participate
Age range
50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 imp…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Difference in Proportion of Participants Between the Primary Care Physician (PCP) Tested Group and the PCP Control Group with at Least 1 Management Action
Timeframe: 6 Months
Trial details
NCT IDNCT07140744
SponsorEli Lilly and Company
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2027-10
Contact for this trial
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or