What side effects are associated with this type of intervention?

Common treatments for Alzheimer's Disease include cholinesterase inhibitors (donepezil, rivastigmine, galantamine) and NMDA receptor antagonists (memantine). Known side effects of cholinesterase inhibitors are nausea, vomiting, diarrhea, muscle cramps, and fatigue. Memantine can cause dizziness, headache, confusion, and constipation. For treatments targeting MTBR-tau species like E2814, specific side effects are not well-documented yet, but potential risks could include infusion-related reactions and effects on the central nervous system, similar to other biologic agents.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Alzheimer's Disease, primarily focusing on amyloid-beta and tau proteins. Notable examples include aducanumab, which targets amyloid plaques, and other investigational drugs like gantenerumab. While E2814 specifically targets MTBR-tau species, similar approaches in clinical trials include drugs aimed at reducing tau aggregation, such as TRx0237. These treatments represent a shift towards addressing tau pathology in Alzheimer's Disease.

What other types of research exist?

Promising novel alternatives to E2814 for Alzheimer's Disease treatment in 2024 include: 1) Lecanemab and Donanemab, which target amyloid-beta plaques; 2) Antisense oligonucleotides targeting tau mRNA; 3) Anti-inflammatory agents like ALZT-OP1; 4) Neuroprotective agents such as BPN14770; and 5) Gene therapies targeting APOE4 or other genetic risk factors. These alternatives are in various stages of clinical development and show potential in modifying disease progression.

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Monoclonal Antibodies

E2814 for Alzheimer's Disease

Phase 1 & 2

Waitlist Available

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

Must not have

History of human immunodeficiency virus (HIV) infection, history of hepatitis B infection within the past year, history of hepatitis C infection which has not been adequately treated, or history of spirochete infection of the central nervous system (e.g., syphilis, Lyme, or borreliosis)

Evidence of other clinically significant lesions on brain MRI at Screening that could indicate a dementia diagnosis other than AD

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

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.

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.

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.

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

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

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I am between 18 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of HIV, recent hepatitis B, untreated hepatitis C, or a CNS spirochete infection.

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My brain MRI shows signs that might suggest a dementia diagnosis other than Alzheimer's.

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I am scheduled for surgery under general anesthesia during the study period.

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I am not pregnant or breastfeeding.

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I do not have any mental health conditions that could affect my participation.

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I do not have a bleeding disorder nor am I on long-term blood thinners.

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I haven't had cancer, except for certain skin, prostate, or breast cancers, in the last 3 years.

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My immune system disease is not well-controlled or needs strong medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 2

~80

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Alzheimer's Disease include cholinesterase inhibitors (donepezil, rivastigmine, galantamine) and NMDA receptor antagonists (memantine). Cholinesterase inhibitors work by increasing levels of acetylcholine, a neurotransmitter important for memory and learning, thereby providing symptomatic relief. Memantine helps by regulating glutamate activity to prevent excitotoxicity, which can damage neurons. E2814, a treatment under study, targets MTBR-tau species in cerebrospinal fluid, aiming to reduce tau pathology, which is a hallmark of Alzheimer's. This approach is significant as it directly addresses the abnormal tau protein accumulation that disrupts neuronal function, potentially modifying disease progression rather than just alleviating symptoms.