E2814 + Lecanemab for Alzheimer's Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the effectiveness of a new treatment, E2814, combined with lecanemab (also known as Leqembi), for individuals with early Alzheimer's disease. Researchers aim to understand how these treatments affect certain brain proteins linked to Alzheimer's. Participants may receive varying doses of E2814 or a placebo (a harmless, inactive treatment) along with lecanemab. Suitable candidates for this trial include those diagnosed with mild cognitive impairment or mild Alzheimer's who have a study partner to support them throughout the trial. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.
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 there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that lecanemab, when used alone, has been safe in past studies. It has helped slow memory and thinking problems in people with Alzheimer's disease and is generally well-tolerated. Early safety information supports further study of lecanemab, even in individuals with a specific genetic type of Alzheimer's.
For E2814, safety information when used with lecanemab is still being collected. Researchers are studying how these two treatments work together. This trial is in Phase 2, indicating that scientists are still learning about the treatment's safety and how well people tolerate it. Being in this phase suggests some initial safety information exists, but more is needed to fully understand its safety in humans.12345Why are researchers excited about this trial's treatments?
Most treatments for Alzheimer's disease focus on managing symptoms with drugs like cholinesterase inhibitors or NMDA receptor antagonists. However, lecanemab is unique because it targets amyloid-beta plaques, a hallmark of Alzheimer's, aiming to slow disease progression rather than just managing symptoms. Researchers are also excited about the combination with E2814, as it represents a novel approach by potentially inhibiting tau propagation, another key factor in Alzheimer's pathology. By addressing both amyloid and tau, these treatments could offer a more comprehensive approach to tackling the disease.
What evidence suggests that this trial's treatments could be effective for Alzheimer's disease?
Research shows that lecanemab, one of the treatments in this trial, can help slow memory and thinking problems in people with early Alzheimer's. In a four-year study, participants taking lecanemab experienced less decline in mental abilities compared to those who did not take it. Lecanemab targets amyloid plaques, protein build-ups in the brain linked to Alzheimer's. E2814, another treatment option in this trial, targets tau, a different protein involved in Alzheimer's. Early research suggests that E2814 might reduce harmful tau proteins in the brain. This trial will explore using E2814 with lecanemab, potentially offering a new way to treat Alzheimer's by addressing both amyloid and tau proteins.16789
Are You a Good Fit for This Trial?
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Lecanemab
Lecanemab is already approved in United States, Japan for the following indications:
- Early symptomatic Alzheimer's disease
- Early symptomatic Alzheimer's disease
Find a Clinic Near You
Who Is Running the Clinical Trial?
Eisai Inc.
Lead Sponsor
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