The U.S. Food & Drug Administration (FDA) has fully approved two anti-amyloid medications to treat early-stage Alzheimer’s disease — lecanemab (2023) and donanemab (2024).
While lecanemab has been available at Cleveland Clinic since 2023, distribution of donanemab is an evolving process. The information here is the latest available. We’ll continue to update this FAQ as we receive more information on the distribution of donanemab.
FAQ
Q. Which anti-amyloid medicines has the FDA approved to treat Alzheimer’s disease?
A. On July 2, 2024, the FDA approved donanemab (Kisunla®; Eli Lilly), a monoclonal antibody or anti-amyloid therapy targeting β-amyloid (Aβ), to treat Alzheimer’s disease.
Lecanemab (LEQEMBI®), another anti-amyloid therapy to treat Alzheimer’s disease, was approved by the FDA in July 2023. At that time, lecanemab was the first new Alzheimer’s drug with full FDA approval in 20 years. It was also one of the first therapies that may slow progression of Alzheimer’s disease, not just treat its symptoms.
Now, patients, in consultation with their neurology providers, can choose between these two fully FDA-approved anti-amyloid therapies.
Q. Can I take more than one anti-amyloid therapy at the same time?
A. No. Lecanemab and donanemab are two different disease-modifying, anti-amyloid treatments. Your neurology provider will help you choose which one is best for you.
Q. Can I continue other medications for Alzheimer’s disease while on an anti-amyloid medication?
A. Yes. You may continue the symptom-modifying medications donepezil, galantamine, rivastigmine or memantine while taking lecanemab or donanemab.
Q. What does anti-amyloid therapy do?
A. Studies show that both lecanemab and donanemab may be able to gradually remove abnormal buildup of the protein, amyloid beta, which causes plaques to form in the brain. In people with the earliest symptomatic stages of Alzheimer’s disease, removing these amyloid beta proteins appears to slow disease progression. Neither lecanemab nor donanemab will completely stop or reverse Alzheimer’s disease.
Q. Who is anti-amyloid therapy for?
A. Anti-amyloid therapy is for people with mild symptoms of Alzheimer’s disease and who’ve had testing to confirm that there are amyloid beta plaques in their brain. A provider’s recommendation for one of these therapies depends on many things and requires a prescription.
Q. Who is anti-amyloid therapy NOT for?
A. Anti-amyloid therapy is NOT for people in the moderate or late stages of Alzheimer’s disease or who’ve been diagnosed with other conditions that cause cognitive impairment. These conditions include Lewy body dementia, vascular dementia, stroke, frontotemporal dementia and Parkinson’s disease. Also, people with more than one health condition (comorbidities) or certain chronic (ongoing) health conditions may not be eligible for anti-amyloid therapy.
Q. How do lecanemab and donanemab work?
A. Both lecanemab and donanemab are monoclonal antibodies. Antibodies “mark” or “label” molecules in the body that the immune system needs to remove. Normally, these are bacteria, viruses, and toxins. Anti-amyloid therapies are manufactured to stick to amyloid beta protein, so the immune system can gradually remove the protein from the brain. Both lecanemab and donanemab are given by infusion — directly into the vein through a needle or catheter. Lecanemab is given every two weeks. Donanemab is given monthly.
Q. Are lecanemab and donanemab safe?
A. As with many medications, lecanemab and donanemab may have side effects. The most common is leaking blood vessels and swelling in the brain or bleeding. That’s why we’ll do regular brain MRI scans during treatment to closely watch for any changes.
Q. When will these anti-amyloid therapies be available?
A. Cleveland Clinic has been administering lecanemab since 2023. Donanemab will likely be available later in 2024. Complexities of a new medication, including Medicare requirements for coverage, may delay donanemab’s availability for clinical use.
Q. I’m a patient at Cleveland Clinic Lou Ruvo Center for Brain Health. How can I be evaluated for anti-amyloid therapy?
A. You can consult with your Center for Brain Health provider about anti-amyloid therapy during your next scheduled appointment. If you don’t have an appointment scheduled, please contact us.
Q. I’m NOT a patient at Cleveland Clinic Lou Ruvo Center for Brain Health. How can I be evaluated for anti-amyloid therapy?
A. If you’re not a patient at the Lou Ruvo Center for Brain Health but are interested in being evaluated for Alzheimer’s disease, please ask your current provider to send a referral to Cleveland Clinic Lou Ruvo Center for Brain Health and then contact us to schedule an appointment.
Q. I’m a patient at the Lou Ruvo Center for Brain Health. Should I make an appointment to come in sooner?
A. Anti-amyloid therapy is a long-term treatment that should not be taken lightly. As with all treatments, there are risks as well as benefits. Anti-amyloid therapy isn’t a cure for Alzheimer’s disease, so talking about the risks of this therapy and weighing them against the benefits should be an important part of your conversation with your provider. If you have questions about lecanemab or donanemab before your next scheduled neurology appointment, please send your care team a message via MyChart.
Q. Is anti-amyloid therapy covered by insurance?
A. Lecanemab is a billable medication, and it’s likely that donanemab will be, too. Your insurance plan can give you information about costs to you. Please contact them directly to learn more.
Q. Are there other Alzheimer’s disease research studies?
A. We have ongoing clinical research studies into potential new treatments. You can learn more at clevelandclinic.org/clinicaltrials. If you live in Nevada, contact us directly at 702.701.7944 or healthybrains@ccf.org.
