Actively Recruiting
A Diagnostic Study Evaluating the Impact of P-tau217 Blood Biomarker Testing on Early Management of Patients with Cognitive Complaint in Primary and Secondary/Tertiary Care
Led by Eli Lilly and Company · Updated on 2025-11-03
7000
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate how P-tau217 blood biomarker testing influences early evaluation and management of patients who present with cognitive complaints. The study focuses on comparing patient management actions between an interventional group receiving the biomarker test and a control group receiving standard care. Both primary care physicians and secondary or tertiary care specialists participate to assess the impact of testing on clinical decisions. Participants are divided into two groups based on their healthcare provider type. Patients in the interventional group undergo P-tau217 blood biomarker testing, while those in the control group receive standard care without the specific biomarker test. The study stratifies participants by whether their doctors are primary care physicians or secondary/tertiary specialists, to observe differences in management actions across these care levels. Throughout the study, researchers track various outcomes including the proportion of patients with management actions taken, timing of referrals, counseling, and initiation of Alzheimer's disease or other therapies. These measures are assessed at 6 and 12 months to understand the impact of biomarker testing on care pathways. Participants provide informed consent and undergo blood sampling, with ongoing monitoring to ensure adherence and completion over the study duration ending in October 2027.
CONDITIONS
Brief Title
A Study Evaluating the Impact of P-tau217 Blood Biomarker Testing on Early Evaluation and Management of Patients Presenting With Cognitive Complaint
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Primary care physicians who routinely evaluate and manage patients over 50 years old in family practice or internal medicine settings.
- Secondary and tertiary care physicians experienced in diagnosing and treating cognitive impairment and dementia.
- Patient participants able and willing to provide signed informed consent.
- Patient participants with sufficient venous access for blood sampling.
- Patient participants willing and able to follow study procedures and remain available for the study duration.
- Patient participants presenting with one or more subjective cognitive complaints within the 4 weeks before identification.
You will not qualify if you...
- Patient participants with prior referral or prescription for cognitive impairment complaints within 18 months before identification.
- Patients who have had previous amyloid or tau biomarker tests such as amyloid PET, tau PET, cerebrospinal fluid tests, or blood tests for amyloid beta or tau.
- Patients with a serious or unstable illness or life expectancy less than 1 year.
- Patients with known brain lesions, pathologies, or alternative diagnoses explaining their clinical symptoms.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At baseline
Participants undergo P-tau217 blood biomarker testing or receive standard of care without P-tau217 testing, based on their assigned group.
1 visit (in-person)
Duration - Up to 12 months
Participants are observed for management actions and outcomes related to cognitive complaints over time.
Follow-up assessments at 6 and 12 months
Trial Site Locations
Total: 1 location
1
SiteRx Virtual Site
New York, New York, United States, 10013
Actively Recruiting
Research Team
T
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
P
Physicians interested in becoming principal investigators please contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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