E2814 for Alzheimer's Disease

No longer recruiting at 2 trial locations

Overseen By Eisai Medical Information

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Eisai Inc.

Must not be taking: Anticoagulants, Antiplatelets, Immunosuppressants, others

Disqualifiers: Stroke, Seizures, Depression, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and effects of a new drug, E2814, for individuals with a rare, inherited form of Alzheimer's disease. Researchers aim to determine how well E2814 is tolerated and whether it interacts with specific brain proteins linked to this type of Alzheimer's. Participants will receive E2814 through regular infusions over varying time frames. This trial may suit individuals with a genetic mutation known to cause inherited Alzheimer's who can manage regular medical visits and procedures. As a Phase 1, Phase 2 trial, the study focuses on understanding how E2814 works in people and measuring its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking research.

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

The trial protocol does not specify if you need to stop taking your current medications. However, certain conditions and treatments, like ongoing use of anticoagulants or participation in other clinical studies, may affect eligibility. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that E2814 is likely to be safe for humans?

Research has shown that E2814 has been tested in people to assess its safety. In early studies, most participants tolerated E2814 well, with no reports of serious side effects directly caused by the treatment. Some participants experienced mild to moderate side effects, but these were manageable and did not require stopping the treatment. This suggests that E2814 might be safe for people with dominantly inherited Alzheimer's disease, although further research is needed to confirm this. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about E2814 for Alzheimer's disease because it targets tau proteins, which play a crucial role in the progression of the disease. Unlike current treatments that primarily focus on managing symptoms or targeting amyloid plaques, E2814 aims to slow down or halt the underlying disease process by interfering with tau propagation. This novel approach could offer a more effective way to combat Alzheimer's, potentially leading to better long-term outcomes for patients.

What evidence suggests that E2814 might be an effective treatment for Alzheimer's disease?

Research suggests that E2814 might help treat Alzheimer's by targeting tau proteins. In individuals with dominantly inherited Alzheimer's disease (DIAD), E2814 has shown promise in preventing tau proteins from spreading and accumulating in the brain. This is crucial because tau buildup is linked to the progression of Alzheimer's. Early studies indicated that E2814 can effectively interact with these proteins in the brain's fluid, showing potential in slowing the disease. Although more information is needed, these findings offer hope for those with DIAD. Participants in this trial will receive E2814 in different cohorts to further evaluate its effectiveness and safety. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 with inherited Alzheimer's, confirmed by specific gene mutations. They must be able to undergo brain scans and tests, have a caregiver to report on their condition, and show early-to-moderate dementia symptoms. Pregnant or breastfeeding women, those with recent substance abuse, certain medical conditions or treatments that could interfere are excluded.

Inclusion Criteria

Evidence of positive amyloid status based on historical or screening amyloid PET

Clinical Dementia Rating - Sum of Boxes (CDR-SB) score 5 to 12 at Screening

I have a confirmed mutation in PSEN1, APP, or PSEN2 linked to early-onset Alzheimer's.

Exclusion Criteria

I have not used effective birth control in the last 3 months.

Any other clinically significant abnormalities in physical examination, vital signs, laboratory tests, or ECG at Screening or Baseline which in the opinion of the investigator require further investigation or treatment or which may interfere with study procedures or safety

Answers 'yes' to Columbia-Suicide Severity Rating Scale (C-SSRS) suicidal ideation Type 4 or 5, or any suicidal behavior assessment within 6 months before Screening, at Screening, or at the Baseline Visit, or has been hospitalized or treated for any suicidal behavior in lifetime

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Phase 1b

Participants receive E2814 as an intravenous infusion at set intervals over 12 weeks

12 weeks

Treatment Phase 2

Participants receive E2814 as an intravenous infusion at set intervals over 96 weeks

96 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• E2814

Trial Overview The study is testing the safety of E2814 infusions in people with dominantly inherited Alzheimer's disease. It will also check how well E2814 targets harmful tau proteins in the brain fluid—a possible cause of memory problems related to Alzheimer's.

How Is the Trial Designed?

Group I: Cohort B: E2814 Experimental Treatment 1 Intervention

Participants will receive E2814 as an intravenous infusion at set intervals over 52 weeks.

Group II: Cohort A, Phase 1b and 2: E2814 Experimental Treatment 1 Intervention

Participants will receive E2814 as an intravenous infusion at set intervals over 12 weeks in Phase 1b and over 96 weeks in Phase 2.

E2814 is already approved in United States for the following indications:

Approved in United States as E2814 for:

• Early Onset Alzheimer's Disease

Who Is Running the Clinical Trial?

Eisai Inc.

Lead Sponsor

Trials

524

Recruited

161,000+

Founded

Eisai Inc. was established in 1995 as the U.S. subsidiary of Eisai Co., Ltd.

Headquarters

Woodcliff Lake, NJ, USA

Known For

Neurology and Oncology

Top Products

Aricept (donepezil), Lenvima (lenvatinib), Leqembi (lecanemab), Halaven (eribulin)

Lynn Kramer

Eisai Inc.

Chief Medical Officer since 2019

MD

Tatsuyuki Yasuno

Eisai Inc.

Chief Executive Officer since 2023

MBA from Kellogg School of Management, Northwestern University; Bachelor of Political Science from Waseda University

Citations

1. eisai.com eisai.com/news/2024/news202480.html

EISAI PRESENTS LATEST CLINICAL FINDINGS ... These results suggest that E2814 inhibited tau propagation and suppressed the accumulation of tau aggregates in brains of people living with DIAD.

2. eisai.com eisai.com/news/2025/news202548.html

Eisai To Present Four-Year Efficacy And Safety Data On ... Eisai's news release Eisai To Present Four-Year Efficacy And Safety Data On Continuous Treatment With Lecanemab At The Alzheimer's ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11114408/

Examining Phase III potential in Alzheimer's therapeutics - PMC The primary outcome assessed changes in Integrated Alzheimer's Disease Rating Scale (iADRS) scores over 76 weeks, revealing a substantial ...

4. prnewswire.com prnewswire.com/news-releases/eisai-to-present-four-year-efficacy-and-safety-data-on-continuous-treatment-with-lecanemab-at-the-alzheimers-association-international-conference-2025-302509714.html

Eisai to Present Four-Year Efficacy and Safety Data on ... Latest findings from Eisai's robust Alzheimer's disease (AD) pipeline include results from lecanemab long-term data, an immunoassay for ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04971733

A Study to Assess Safety and Target Engagement of E2814 ... The primary objective of the study is to assess the safety and tolerability of intravenous (IV) infusions of E2814 in participants with dominantly inherited ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12360189/

An Anti-tau Therapeutic Antibody Etalanetug (E2814) Herein, we present the data of the results for the first-in-human assessment of safety, tolerability, pharmacokinetics (PK), immunogenicity, and ...