E2814 + Lecanemab for Alzheimer's Disease

Recruiting in Palo Alto (17 mi)

+33 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Eisai Inc.

Must be taking: Acetylcholinesterase inhibitors

Must not be taking: Antipsychotics, Anticoagulants

Disqualifiers: Neurological conditions, Stroke, Seizures, others

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

The primary objective of the study is to determine the dose response of E2814, when concurrently administered with lecanemab, on the change from baseline at 6 months in cerebrospinal fluid (CSF) microtubule-binding region (MTBR)-tau-243 in participants with early Alzheimer's disease (AD).

Will I have to stop taking my current medications?

The trial requires that participants be on stable doses of any approved Alzheimer's medications for at least 12 weeks before starting. For other medications, they must be on stable doses for at least 4 weeks before the trial begins. If you are taking memantine and are in Japan, you cannot participate.

Is lecanemab safe for humans?

Lecanemab has been studied for safety in people with Alzheimer's disease, and while it has shown some effectiveness in reducing brain amyloid-β (a protein linked to Alzheimer's), the safety data is primarily from trials with patients in the early stages of the disease. It is important to consult with a healthcare provider for personalized advice, as safety data for other conditions or stages is not available. ^{1 2 3 4 5}

How is the drug Lecanemab unique in treating Alzheimer's disease?

Lecanemab is unique because it is a monoclonal antibody (a type of protein made in the lab) that targets and clears amyloid-β, a protein that builds up in the brains of people with Alzheimer's, helping to slow down cognitive decline in early stages of the disease. ^{1 2 3 5 6}

Eligibility Criteria

This trial is for people aged 50-80 with early Alzheimer's, who score between 22 and 30 on the MMSE. They must meet criteria for probable AD dementia or MCI due to AD, have stable medication use, and a study partner available. Those on anticoagulants or unstable in other meds can't join.

Inclusion Criteria

I have been diagnosed with mild cognitive impairment likely due to Alzheimer's.

My memory issues are mild but noticeable.

I have been diagnosed with probable Alzheimer's disease.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive E2814 or placebo as an IV infusion every four weeks and lecanemab as a SC injection every week for up to 18 months

18 months

IV infusion every 4 weeks, SC injection every week

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Treatment Details

Interventions

• Lecanemab (Monoclonal Antibodies)

Trial Overview The trial tests E2814's effect on tau proteins in the brain when given with Lecanemab to those with early Alzheimer's. It measures changes after six months to see if it slows disease progression compared to a placebo.

Participant Groups

Group I: Placebo + Lecanemab Experimental Treatment 2 Interventions

Participants will receive placebo administered as an IV infusion, Q4W along with lecanemab administered as a SC injection, QW for up to 18 months.

Group II: E2814 Dose D + Lecanemab Experimental Treatment 2 Interventions

Participants will receive E2814 Dose D administered as an IV infusion, Q4W along with lecanemab administered as a SC injection, QW for up to 18 months.

Group III: E2814 Dose C + Lecanemab Experimental Treatment 2 Interventions

Participants will receive E2814 Dose C administered as an IV infusion, Q4W along with lecanemab administered as a SC injection, QW for up to 18 months.

Group IV: E2814 Dose B + Lecanemab Experimental Treatment 2 Interventions

Participants will receive E2814 Dose B administered as an IV infusion, Q4W along with lecanemab administered as a SC injection, QW for up to 18 months.

Group V: E2814 Dose A + Lecanemab Experimental Treatment 2 Interventions

Participants will receive E2814 Dose A administered as an intravenous (IV) infusion, every four weeks (Q4W) along with lecanemab administered as a subcutaneous (SC) injection, every week (QW) for up to 18 months.

Lecanemab is already approved in United States, Japan for the following indications:

🇺🇸 Approved in United States as Leqembi for:

• Early symptomatic Alzheimer's disease

🇯🇵 Approved in Japan as Leqembi for:

• Early symptomatic Alzheimer's disease

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of California at San Francisco/UCSF San Francisco, CA

Axiom Brain Health Tampa, FL

Columbus Memory Center, PC Columbus, GA

Memory Center/Hattiesburg Clinic Hattiesburg, MS

More Trial Locations

Who Is Running the Clinical Trial?

Eisai Inc. Lead Sponsor

References

1. England pubmed.ncbi.nlm.nih.gov

Evidence for lecanemab in early Alzheimer's disease. [2023] Overview of: van Dyck CH, Swanson CJ, Aisen P, et al Lecanemab in Early Alzheimer's Disease. N Engl J Med 2023;388:9-21.

2. New Zealand pubmed.ncbi.nlm.nih.gov

Lecanemab: First Approval. [2023] Lecanemab (lecanemab-irmb; LEQEMBI™) is a humanized immunoglobulin gamma 1 (IgG1) against aggregated soluble and insoluble forms of amyloid-β peptide. It is being developed by Eisai, under a global licence from BioArctic (formerly BioArctic Neuroscience), and in collaboration with Biogen, for the treatment of Alzheimer's disease, and received its first approval for this indication on 6 January 2023 in the USA under the Accelerated Approval Pathway. According to the US prescribing information, treatment should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, and a confirmed presence of amyloid beta pathology (i.e. the population in which treatment was initiated in clinical trials). There are no effectiveness or safety data on initiating treatment at earlier or later stages of the disease than were studied. Lecanemab is undergoing regulatory review in the EU, Japan and China, with clinical development underway in several other countries worldwide. This article summarizes the milestones in the development of lecanemab leading to this first approval for the treatment of Alzheimer's disease.

3. United States pubmed.ncbi.nlm.nih.gov

Lecanemab reduces brain amyloid-β and delays cognitive worsening. [2023] Lecanemab cleared amyloid-β in two-thirds and reduced the rate of cognitive and functional worsening in people with mild cognitive impairment and mild dementia due to Alzheimer disease in an 18-month double-blinded randomized placebo-controlled trial reported by van Dyck et al.

4. Switzerland pubmed.ncbi.nlm.nih.gov

Safety and efficacy of lecanemab for Alzheimer's disease: a systematic review and meta-analysis of randomized clinical trials. [2023] We performed a systematic review and meta-analysis of the cognitive effectiveness and safety of lecanemab on subjects with Alzheimer's disease (AD).

5. United States pubmed.ncbi.nlm.nih.gov

Lecanemab: A Humanized Monoclonal Antibody for the Treatment of Early Alzheimer Disease. [2023] To review current pharmacology, pharmacokinetics/pharmacodynamics, safety, and efficacy of lecanemab in patients with Alzheimer disease.

6. New Zealand pubmed.ncbi.nlm.nih.gov

A Path to Improved Alzheimer's Care: Simulating Long-Term Health Outcomes of Lecanemab in Early Alzheimer's Disease from the CLARITY AD Trial. [2023] Alzheimer's disease (AD), a progressive neurodegenerative disease, is the main cause of dementia and one of the leading causes of death for elderly people in the USA. Lecanemab is a humanized IgG1 monoclonal antibody targeting amyloid protofibrils for the treatment of early AD [i.e., mild cognitive impairment (MCI) or mild AD dementia]. In a recent 18-month phase III trial, using a double-blind, placebo-controlled design, lecanemab treatment led to reduced brain amyloid burden and significant improvements in cognitive and functional abilities in individuals with early AD.