Lecanemab (Leqembi™) has received accelerated approval as a treatment for early Alzheimer's from the U.S. Food and Drug Administration (FDA).
Lecanemab (Leqembi™) FAQs
Is lecanemab a cure for Alzheimer's and all other dementia?
No. Lecanemab is not a cure. But it is a second approved treatment that addresses the underlying biology of Alzheimer's and changes the course of the disease in a meaningful way for people in the early stages. The first FDA-approved treatment was aducanumab (Aduhelm™).
By slowing progression of the disease when taken in the early stages of Alzheimer's, individuals will have more time to participate in daily life and live independently.
Who should take this drug?
The FDA prescribing information specifies that lecanemab is appropriate for people with early Alzheimer's with confirmation of elevated beta-amyloid. The treatment was studied in people living with early Alzheimer's dementia and MCI due to Alzheimer's who showed evidence of a buildup of beta-amyloid plaques in the brain. The therapy has not been tested on people with more advanced stages of Alzheimer's or those without clinical symptoms.
How to navigate treatment options
There is exciting progress in Alzheimer’s and dementia research that is creating promising new treatments. It is important to learn as much as you can about which drugs are available.
Will this drug restore memories or cognitive function that has been lost?
There is no evidence this or any treatment can restore or reverse lost memories or cognitive function due to Alzheimer's disease.
What type of diagnostic test is the FDA requiring?
There is no single diagnostic test that can determine if a person has Alzheimer's disease. Physicians use a variety of approaches and tools to help make a diagnosis. To diagnose Alzheimer's, physicians may use medical history, mental status tests, physical and neurological exams, diagnostic tests and brain imaging.
Before initiating this anti-amyloid treatment, the prescribing information requires that a physician confirms the presence of beta-amyloid plaques. The FDA does not specify a diagnostic tool to determine elevated beta-amyloid, but tools such as an amyloid PET scan or lumbar puncture (CSF tests) are examples.
How do I receive this treatment?
If you or a loved one is experiencing memory changes, the Alzheimer's Association strongly encourages speaking with a health care provider for a thorough evaluation and diagnosis. Individuals should talk with their health care provider to develop a treatment plan that is right for them, including weighing the benefits and risks of all approved therapies.
What is mild cognitive impairment?
Mild cognitive impairment (MCI) is an early stage of memory loss or other cognitive ability loss in individuals who maintain the ability to independently perform most activities of daily living.
How much will this drug cost?
In a news release, the manufacturers of lecanemab announced they are setting the price of the drug at $26,500 a year.
Will Medicare cover lecanemab?
In April 2022, the Centers for Medicare & Medicaid Services (CMS) issued an unprecedented decision that all but denies coverage of FDA-approved treatments that target beta-amyloid for Alzheimer's disease. This policy applies to all currently FDA-approved anti-amyloid monoclonal antibody treatments for Alzheimer's, including lecanemab.
The Association filed a formal request asking CMS to provide full and unrestricted coverage for FDA-approved Alzheimer's treatments.
Will Medicaid cover lecanemab?
For people who are on Medicaid only (not dual eligible) with limited exceptions, state Medicaid programs will cover all FDA-approved drugs. While all drugs are required to be covered across state Medicaid programs, utilization management restrictions and drug list placement can vary significantly.
The Association is working with state Medicaid agencies to expedite access to FDA-approved treatments for all of those who would likely benefit.
How is this drug administered?
The treatment is administered through an IV every two weeks, lasting 45 to 60 minutes for each infusion. Typically, infusions can be done at hospitals and infusion therapy centers.
When will it be available at my doctor?
Now that the drug is approved, ramping up manufacturing — and eventually nationwide distribution and implementation — will take some time. Ask your doctor about availability.
Communicate with your health care team
Effective communication with care team members — particularly health care providers — is critical to ensure that the person living with dementia receives the best possible care.
What are the side effects?
All drugs have side effects. As with other anti-amyloid treatments in this class of drugs, lecanemab does have side effects. The most common reported side effects were infusion-related reactions, headache and amyloid-related imaging abnormalities (ARIA). Individuals should talk with their doctors to develop a treatment plan that is right for them, including weighing the benefits and risks of all approved therapies.
Can I take this drug with my other medications/supplements?
When considering any treatment, it is important to have a conversation with your health care provider to ensure you are a candidate for the treatment. This includes taking into account other health conditions, medications or supplements.
How does lecanemab (Leqembi) compare to aducanumab (Aduhelm)?
While monoclonal antibodies that target beta-amyloid in the brain belong to the same class of treatments, no two treatments are the same. Each works differently and at different stages of beta-amyloid plaque formation, and ultimately slow progression of the disease and reduce clinical decline.
ALZ Talks: Alzheimer's Treatment Update
Alzheimer's Association Chief Public Policy Officer Robert Egge and Senior Director of Medical Scientific Relations Dr. Claire Sexton provided an update on lecanemab, the anti-amyloid treatment just approved by the FDA. They reviewed additional details about the drug and potential side effects and benefits, and addressed next steps around access to the treatment.