Screening for Alzheimer's Disease Risk

Enrolling by invitation at 3 trial locations

Overseen By Eisai Medical Information

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Eisai Limited

Disqualifiers: Uncontrolled medical conditions, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial seeks individuals at high risk for Alzheimer's Disease using simple blood tests. It seeks participants who either show symptoms of Alzheimer's or have concerns about their risk, particularly those with a family history or specific genetic markers. Those who have noticed memory problems or have a family member who developed dementia before age 75 may be suitable candidates. The researchers aim to learn more about how blood-based biomarker tests can help identify Alzheimer's risk early. As a Phase 3 trial, this is the final step before FDA approval, offering participants an opportunity to contribute to a potentially groundbreaking treatment.

Do I need to stop my current medications for this trial?

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

What prior data suggests that blood-based biomarkers are safe for screening Alzheimer's Disease risk?

Research has shown that blood tests for Alzheimer's Disease are generally safe and easy to handle. These tests detect specific proteins in the blood to help identify the disease. The process is simple and avoids surgery or other uncomfortable procedures.

Studies have found that blood tests for Alzheimer's are rapidly improving, enhancing their reliability and acceptance. The FDA has approved a blood test for diagnosing Alzheimer's, which boosts confidence in its safety and effectiveness.

Overall, blood tests provide a safe method to assess Alzheimer's risk, with no major safety issues reported in studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using blood-based biomarkers to screen for Alzheimer's disease risk because this approach offers a non-invasive and potentially more accessible way to detect the disease early. Unlike traditional methods like PET scans or cerebrospinal fluid analysis, which can be costly and invasive, blood tests are simpler and more convenient for patients. Additionally, identifying biomarkers in the blood could allow for earlier intervention before significant symptoms appear, potentially slowing disease progression and improving outcomes.

What evidence suggests that blood-based biomarkers are effective for screening Alzheimer's Disease risk?

Studies have shown that blood tests aid in the early detection and diagnosis of Alzheimer's Disease (AD). These tests detect specific proteins in the blood, such as phosphorylated tau and amyloid-beta, which are associated with AD. Research indicates that these proteins can predict disease progression, providing doctors with a clearer understanding of what to expect. Some studies suggest that changes in these proteins can indicate treatment effectiveness. Overall, blood tests are gaining popularity for their potential to simplify and improve the accuracy of diagnosing and monitoring Alzheimer's. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

Inclusion Criteria

You are open to being referred to a clinical facility if you meet the requirements.

You are a man or woman aged 50 to 80 years old, and have given permission for the study.

You have a direct ancestor who experienced the onset of dementia before age 75.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Observation

Participants with or without symptoms of Alzheimer's Disease are observed for amyloid pathology using blood-based biomarkers

Follow-up

Participants are monitored for safety and effectiveness after initial screening

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Blood-based Biomarkers

How Is the Trial Designed?

Group I: All Participants Experimental Treatment 1 Intervention

Participants with or without symptoms of AD will be enrolled and observed in this study.

Who Is Running the Clinical Trial?

Eisai Limited

Lead Sponsor

Trials

63

Recruited

14,300+

Founded

N/A

Headquarters

N/A

Known For

Neurology & Oncology

Top Products

LEQEMBI, Lenvima, Halaven, Fycompa

Haruo Naito

Eisai Limited

Chief Executive Officer since 1988

Bachelor's degree in Economics from Keio University

Lynn Kramer

Eisai Limited

Chief Medical Officer

MD from Tokyo Medical University

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12501330/

Disclosure of Alzheimer's disease blood-based biomarker ... Available data suggests that disclosure of AD risk or biomarker test results can be performed safely and have numerous benefits. In research ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2950347724000537

Blood-based biomarkers of Alzheimer's disease—A ... These recommendations focus on the use of blood-based biomarkers for clinical diagnosis, early screening for AD, and predicting disease progression.

3. alz-journals.onlinelibrary.wiley.com alz-journals.onlinelibrary.wiley.com/doi/abs/10.1002/alz.088292

Blood‐based Biomarkers to Evaluate the Effectiveness of ... Evaluating the effectiveness of individualized AD/NDD risk reduction care is feasible with blood-based biomarkers. Improvements in amyloid and ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2842215

Longitudinal Blood-Based Biomarkers and Clinical ... Blood-based biomarkers for AD include phosphorylated tau 217 (pTau217), reflecting both amyloid and tau pathology; amyloid-β42/40 ratio (Aβ42/40) ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2863057/

Blood-based biomarkers of Alzheimer's disease: challenging ... Increasing evidence suggests that there is a blood protein signature, and possibly a transcript signature, that might act to increase confidence in diagnosis.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5218961/

Blood Based Biomarkers in Alzheimer Disease Blood-based biomarkers have significant advantages of being time- and cost-efficient as well as reduced invasiveness and increased patient acceptance. Despite ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2274580725002535

Disclosure of Alzheimer's disease blood-based biomarker ... Blood-based biomarkers (BBMs) for Alzheimer's disease (AD) have advanced rapidly and may be a critical tool for broad community-based screening for AD and ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06477484

Blood Biomarkers for Screening of Alzheimer's Disease The goal of this observational study is to estimate the screen performance of blood biomarkers of interest (Aβ40 and Aβ42, P-Tau181, P-Tau217, GFAP and NfL) in ...

9. alz-journals.onlinelibrary.wiley.com alz-journals.onlinelibrary.wiley.com/doi/10.1002/alz.70535

Alzheimer's Association Clinical Practice Guideline on the use ... The blood-based biomarker guideline presented in this manuscript specifically provides guidance on whether blood tests for Alzheimer's disease ...

10. 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 US Food and Drug Administration today cleared for marketing the first in vitro diagnostic device that tests blood to aid in diagnosing Alzheimer's disease.