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Monoclonal Antibodies

E2814 for Alzheimer's Disease

Phase 1 & 2
Recruiting
Research Sponsored by Eisai Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Individuals who are confirmed to be mutation positive for presenilin 1 (PSEN1), amyloid precursor protein (APP), or presenilin 2 (PSEN2) gene that is associated with DIAD
Male or female, age 18 to 80 years at the time of informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up cohort a, days 1 and 85: 0-672 hours post-infusion; cohort b, day 1 up to day 449: 0-672 hours post-infusion
Awards & highlights

Study Summary

This trial is testing a new drug for Alzheimer's Disease. The goal is to see if it is safe and if it affects a protein in the brain that is linked to the disease.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects aren't specified but may include reactions at the infusion site, general discomforts like headaches or nausea, and possibly allergic reactions due to sensitivity towards E2814 or similar medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a confirmed mutation in PSEN1, APP, or PSEN2 linked to early-onset Alzheimer's.
Select...
I am between 18 and 80 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cohort a, days 1 and 85: 0-672 hours post-infusion; cohort b, day 1 up to day 449: 0-672 hours post-infusion
This trial's timeline: 3 weeks for screening, Varies for treatment, and cohort a, days 1 and 85: 0-672 hours post-infusion; cohort b, day 1 up to day 449: 0-672 hours post-infusion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cohort A, Phase 1b: Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings
Cohort A, Phase 1b: Number of Participants With Clinically Significant Vital Signs Values
Cohort A, Phase 1b: Number of Participants With Markedly Abnormal Laboratory Values
+9 more
Secondary outcome measures
CSF Concentrations of E2814
Change From Baseline in CSF Concentrations of Total tau (t-tau) and Phosphorylated tau (p-tau)
Change From Baseline in tau Positron Emission Tomography (PET) Signal
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort B: E2814Experimental Treatment1 Intervention
Participants will receive E2814 as an intravenous infusion at set intervals over 52 weeks.
Group II: Cohort A, Phase 1b and 2: E2814Experimental Treatment1 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
E2814
2019
Completed Phase 1
~80

Find a Location

Who is running the clinical trial?

Eisai Inc.Lead Sponsor
515 Previous Clinical Trials
154,072 Total Patients Enrolled

Media Library

E2814 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04971733 — Phase 1 & 2
Alzheimer's Disease Research Study Groups: Cohort B: E2814, Cohort A, Phase 1b and 2: E2814
Alzheimer's Disease Clinical Trial 2023: E2814 Highlights & Side Effects. Trial Name: NCT04971733 — Phase 1 & 2
E2814 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04971733 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants able to join this clinical investigation?

"Clinicaltrials.gov does not list this clinical trial as actively recruiting patients at the moment, with its original post date being June 28th 2021 and latest update on May 24th 2022. However, there are still 980 other studies that are looking for participants to join their trials."

Answered by AI

Is my participation in this medical study feasible?

"This clinical trial is recruiting 8 individuals aged 18 to 80 who have been diagnosed with Alzheimer's disease. To qualify, candidates must be either male or female and possess a confirmed mutation of the PSEN1, APP, or PSEN2 gene related to DIAD. Additionally, their CDR-SB score should range between 5 and 12 at screening; they need evidence of amyloid positivity in an amyloid PET scan; consent to MRI, lumbar puncture (LP), and other study tests/evaluations; provide an informant that can accurately assess cognitive/functional abilities; plus agree to supply necessary information during visits requiring"

Answered by AI

Is the age requirement for this research study limited to individuals 40 years and younger?

"This research necessitates that the participants are between 18 and 80 years of age, with 44 trials for minors and nearly a thousand studies dedicated to those 65 or over."

Answered by AI

Who else is applying?

What site did they apply to?
UC San Diego Altman Clinical and Translational Research Insititute Clinic
What portion of applicants met pre-screening criteria?
Met criteria
~4 spots leftby Jul 2025