Lecanemab for Alzheimer's Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing lecanemab, a drug aimed at improving memory and thinking skills in people with early signs of Alzheimer's disease. The drug works by reducing amyloid plaques in the brain, which are believed to contribute to Alzheimer's. Researchers want to see if lecanemab is effective over several years.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, it mentions that taking certain prohibited medications may exclude you from participating. It's best to discuss your current medications with the trial team to see if they are allowed.
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, the safety data is primarily available for this condition. It is important to discuss with a healthcare provider to understand the potential risks and benefits for your specific situation.12345
What makes the drug lecanemab unique for treating Alzheimer's disease?
Lecanemab is unique because it is a humanized antibody that targets and clears amyloid-β, a protein linked to Alzheimer's, and is specifically approved for early stages of the disease. It has shown to reduce brain amyloid-β and slow cognitive decline in patients with mild cognitive impairment or mild dementia.12345
Are You a Good Fit for This Trial?
This trial is for men and women aged 55-80 with early signs of Alzheimer's, indicated by certain levels of brain amyloid. Participants must have a good memory score and be generally healthy without severe psychiatric issues or recent drug/alcohol abuse. Women who are pregnant or breastfeeding, people sensitive to monoclonal antibodies, HIV positive individuals, those with uncontrolled bleeding disorders or immunological diseases can't join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive lecanemab or placebo as IV infusion every two to four weeks for 216 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Extension
Participants may continue to receive lecanemab in an extension phase for up to 312 weeks
What Are the Treatments Tested in This Trial?
Interventions
- Lecanemab
- Placebo
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
Biogen
Industry Sponsor
Daniel Quirk
Biogen
Chief Medical Officer
MD
Christopher A. Viehbacher
Biogen
Chief Executive Officer since 2022
Graduated from Queen's University, Kingston, Ontario, Canada
National Institute on Aging (NIA)
Collaborator
Alzheimer's Clinical Trials Consortium
Collaborator