P-tau217 Test for Alzheimer's Disease

(ANCHOR-AD Trial)

Recruiting at 2 trial locations

Overseen By Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Eli Lilly and Company

Must not be taking: Amyloid therapy, Cholinesterase inhibitors

Disqualifiers: Cognitive impairment, Neurodegenerative disease, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 8

3400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a specific blood test, the P-tau217 Test, could predict changes in memory and thinking skills, particularly related to Alzheimer's disease. The researchers aim to determine if certain P-tau217 levels in the blood link to worsening cognitive abilities over time. Participants will be divided into two groups based on their P-tau217 levels. Suitable candidates are those who feel their thinking and memory are normal, have not sought medical advice for memory issues, and haven't participated in Alzheimer's drug studies. The trial will last about seven years, focusing on individuals without current memory problems. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking diagnostic tool for Alzheimer's.

Will I have to stop taking my current medications?

If you are currently using medications for mild cognitive impairment or dementia, like amyloid targeting therapy or cholinesterase inhibitors, you cannot participate in this trial. The protocol does not specify about other medications, so it's best to discuss with the trial team.

Is there any evidence suggesting that the P-tau217 Test is likely to be safe for humans?

Research has shown that the P-tau217 test is a promising tool for detecting Alzheimer's disease. Studies have found it can predict Alzheimer's with an accuracy of 88% to 92%. This test, primarily a blood test, is considered safe for patients. The main concern is its potential for incorrect results, such as false positives or negatives. However, no major safety issues have been reported with the test itself, indicating that patients generally tolerate it well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the P-tau217 test for Alzheimer's because it offers a potentially groundbreaking way to detect the disease early. Unlike current methods, which often rely on expensive and invasive procedures like PET scans or lumbar punctures, the P-tau217 test is a simple blood test. It targets a specific protein, P-tau217, known to be associated with Alzheimer's, allowing for early detection in people who are still cognitively unimpaired. This could lead to earlier interventions and better management of the condition, changing the landscape of Alzheimer's diagnosis.

What evidence suggests that the P-tau217 Test is effective for Alzheimer's Disease?

Research has shown that plasma P-tau217 is a strong indicator for Alzheimer's disease. Studies have found that this test can predict Alzheimer's with 81% accuracy, correctly identifying the disease in many cases. In another study, a specific method increased accuracy to 92–94% in medical settings. This test effectively connects with key Alzheimer's markers in the brain and spinal fluid. In this trial, participants will be grouped based on their plasma P-tau217 levels, with one group having elevated levels and another having non-elevated levels. Overall, plasma P-tau217 helps identify memory problems related to Alzheimer's, making it a promising tool for early detection and monitoring. ^{1 6 7 8 9}

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 study is for individuals who believe they have normal memory and thinking abilities. They must be able to read, see, and hear well enough for tests. People can't join if they've taken certain dementia drugs, seen a doctor for memory issues, or been in drug trials for Alzheimer's.

Inclusion Criteria

I believe my thinking and memory are normal.

Participant must have adequate literacy, vision, and hearing for neuropsychological assessments at the time of screening

Exclusion Criteria

I have taken prescription drugs for memory loss or dementia.

History of seeing a doctor about memory concerns

History or diagnosis of cognitive impairment, or significant other neurodegenerative disease that can affect cognition

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial cognitive and biomarker assessments to establish baseline measurements

1-2 weeks

1 visit (in-person)

Annual Assessment

Annual plasma P-tau217 testing and cognitive assessments

7 years

7 visits (in-person, annually)

Follow-up

Participants are monitored for cognitive changes and health outcomes

7 years

What Are the Treatments Tested in This Trial?

Interventions

• P-tau217 Test

Trial Overview The AACU study is looking at how often cognitive skills get worse over time in people with different levels of P-tau217—a potential marker found in blood that might indicate Alzheimer's Disease—using the P-tau217 Test.

How Is the Trial Designed?

Group I: Not-Elevated P-tau217 Levels Experimental Treatment 1 Intervention

Participants with known not-elevated plasma P-tau217 levels who are cognitively unimpaired at baseline per self-report.

Group II: Elevated Plasma P-tau217 Levels Experimental Treatment 1 Intervention

Participants with known elevated plasma P-tau217 levels who are cognitively unimpaired at baseline per self-report.

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/PMC11694372/

Plasma phospho-tau217 as a predictive biomarker for ... Compared to other p-tau isoforms, plasma p-tau217 exhibits stronger associations with AD hallmarks in CSF and brain.

2. nature.com nature.com/articles/s41591-025-03622-w

Plasma phospho-tau217 for Alzheimer's disease diagnosis ... Using a two-cutoff approach, accuracies increased to 92–94% in secondary and primary care, excluding 12–17% with intermediate results. Using the ...

3. jamanetwork.com jamanetwork.com/journals/jamaneurology/fullarticle/2838887

Plasma Phosphorylated Tau 217 to Identify Preclinical ... As a stand-alone test, plasma p-tau217 achieved a positive predictive value (PPV) of 79% (95% CI, 74-84) and an overall accuracy of 81% (95% CI, ...

4. fda.gov fda.gov/news-events/press-announcements/fda-clears-first-blood-test-used-diagnosing-alzheimers-disease

FDA Clears First Blood Test Used in Diagnosing ... The risks associated with the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio are mainly the possibility of false positive and false negative ...

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

Plasma phosphorylated tau 217 strongly associates with ... Together, our results suggest that plasma p-tau217 stands out as a biomarker capable of identifying memory deficits attributable to Alzheimer's disease and that ...

6. mayocliniclabs.com mayocliniclabs.com/test-catalog/Overview/621635

PT217 - Overview: Phospho-Tau 217, Plasma Evaluation of individuals, aged 50 years and older, presenting with cognitive impairment who are being assessed for Alzheimer disease and other causes of ...

7. nih.gov nih.gov/news-events/nih-research-matters/accurate-blood-test-alzheimer-s-disease

Accurate blood test for Alzheimer's disease Across all the participants, the blood test predicted a diagnosis of Alzheimer's disease with 88% to 92% accuracy. Further analysis found that ...

8. quanterix.com quanterix.com/p-tau-217-a-promising-blood-based-biomarker-for-alzheimers-disease/

P-Tau 217 Protein: A Biomarker For Alzheimer's p-Tau 217 may serve as a promising blood-based biomarker to aid in AD research, drug development, diagnosis, disease monitoring and patient care.

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 ...