E2814 for Alzheimer's Disease

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

8 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing the safety and tolerability of a drug called E2814 in people with a genetic form of Alzheimer's disease. The study also aims to see how well E2814 interacts with certain elements in the brain. The goal is to find out if this drug can help manage or slow down the disease.

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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