P-tau217 Testing for Mild Cognitive Impairment

Overseen By There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Eli Lilly and Company

Disqualifiers: Previous amyloid/tau tests, serious illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

7000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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 Is on the Research Team?

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

This trial is for individuals experiencing mild cognitive impairment. Specific eligibility criteria are not provided, but typically participants would need to meet certain health standards and may be excluded based on factors like other medical conditions or treatments that could interfere with the study.

Inclusion Criteria

Tertiary care physicians (TCPs): specialty neurologists who focus on certain neurological conditions

Patient Participant Criteria:

Participants in the interventional group are eligible to be included in the study only if all the following criteria apply:

Exclusion Criteria

Participants with previous amyloid- or tau-specific tests, defined as

Amyloid position emission tomography (PET)

Tau PET

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Patient participants in the interventional group will undergo P-tau217 testing

6 months

Standard of Care

Patient participants in the standard of care group will not undergo P-tau217 testing

6 months

Follow-up

Participants are monitored for management actions and outcomes related to cognitive complaints

6-12 months

What Are the Treatments Tested in This Trial?

Interventions

• P-tau217

Trial Overview The study is examining if testing for P-tau217, a blood biomarker, affects how doctors manage patients with cognitive complaints compared to standard care without this test. It's looking at whether there's a difference in treatment decisions between two groups: one receiving the biomarker test and one not.

How Is the Trial Designed?

Group I: Standard of Care Group Experimental Treatment 1 Intervention

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

Group II: Interventional Group Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University