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?

This trial aims to determine if a test called P-tau217 can help doctors better manage patients with mild cognitive issues, such as memory problems or trouble concentrating. Participants will either receive this test or continue with their usual care. The study focuses on individuals who have recently noticed cognitive issues but have not undergone specialized tests or treatment. This trial suits those who have experienced recent memory slips or concentration challenges but have not yet been referred for specialized testing or treatments. As an unphased trial, it offers a unique opportunity for participants to contribute to the understanding of cognitive health management.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that P-tau217 testing is safe for mild cognitive impairment?

Research has shown that the P-tau217 test is a promising method for identifying and tracking memory and thinking problems. Studies have found that this test can predict these issues years before they occur. It matches or surpasses the effectiveness of some FDA-approved tests for detecting Alzheimer's disease.

While specific safety information about the P-tau217 test is not detailed, it is a blood test, and similar tests are generally safe and well-tolerated. No major side effects have been reported for this type of test, making it a potentially safe choice for those considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about P-tau217 testing for mild cognitive impairment because it targets a specific protein, P-tau217, that is believed to be a key indicator of Alzheimer's disease. Unlike traditional methods that rely on cognitive assessments or broader biomarkers, this testing aims to detect changes at a molecular level, potentially leading to earlier and more precise diagnosis. By focusing on P-tau217, this method could improve the ability to differentiate between Alzheimer's and other types of cognitive decline, paving the way for more tailored treatments in the future.

What evidence suggests that P-tau217 testing is effective for mild cognitive impairment?

Research has shown that p-tau217 is a promising tool for identifying Alzheimer's disease. Studies indicate that it can effectively detect Alzheimer's-related changes in the brain. In one study, a blood test for p-tau217 matched the accuracy of brain scans in predicting cognitive decline. This trial will compare two groups: participants in the interventional group will undergo p-tau217 testing, while those in the standard of care group will not receive sponsor-provided p-tau217 testing. Overall, p-tau217 testing has demonstrated strong potential in diagnosing and understanding mild memory issues linked to Alzheimer's. ^{6 7 8 9 10}

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

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12538628/

Predicting cognitive decline with amyloid‐PET, plasma p‐ ... The plasma Aβ42/40 ratio and levels of tau phosphorylated at threonine 217 (p‐tau217) are among the most promising blood‐based biomarkers that ...

2. jamanetwork.com jamanetwork.com/journals/jamaneurology/fullarticle/2813751

Diagnostic Accuracy of a Plasma Phosphorylated Tau 217 ... This study highlights the effectiveness of a commercially available plasma p-tau217 assay in identifying AD pathology. Our findings demonstrate ...

3. nature.com nature.com/articles/s43587-025-00835-z

Plasma p-tau217 and tau-PET predict future cognitive ... Plasma p-tau217 and tau-PET showed similar performance for predicting future cognitive decline in CU individuals, and their sequential use enhances screening ...

4. alz-journals.onlinelibrary.wiley.com alz-journals.onlinelibrary.wiley.com/doi/full/10.1002/dad2.70119

Exploring the association between mild behavioral impairment ... Interpretation: Our findings reveal that MBI is associated with higher plasma p-tau217 levels and increased odds of p-tau217 positivity in ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2274580724006034

Informing etiological heterogeneity of mild cognitive ... The main goal of this study was to evaluate differences between individuals with MCI with and without plasma p-tau217 biomarker evidence of AD.

6. alz-journals.onlinelibrary.wiley.com alz-journals.onlinelibrary.wiley.com/doi/full/10.1002/alz.14537

Plasma p‐tau217 identifies cognitively normal older adults ... Plasma p-tau217 identifies cognitively normal older adults who will develop cognitive impairment in a 10-year window.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12122256/

Repeated plasma p‐tau217 measurements to monitor ... Three progression clusters emerged in both cohorts: stable cognition, slow decline, and rapid decline—each including cases initially classified ...

8. academic.oup.com academic.oup.com/brain/article/148/7/2384/7989401

Plasma phosphorylated tau 217 strongly associates with ... We found that plasma p-tau217 was more associated with cognitive performance than p-tau181 and p-tau231 and that this relationship was particularly strong for ...

9. nature.com nature.com/articles/s41591-024-02869-z

Highly accurate blood test for Alzheimer's disease is similar ... Blood plasma %p-tau217 demonstrated performance that was clinically equivalent or superior to clinically used FDA-approved CSF tests in the detection of AD ...

10. jnnp.bmj.com jnnp.bmj.com/content/95/11/1046

Clinical value of plasma ALZpath pTau217 immunoassay for ... Results Among participants with MCI, 55% were Aβ+ and 29% developed dementia due to AD. pTau181 and pTau217 were higher in the Aβ+ population with fold ...