E2814 + Lecanemab for Alzheimer's Disease

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.

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.

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.

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.

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