The FDA has approved the medicine lecanemab for the treatment of Alzheimer’s disease.
Please note: The distribution of lecanemab is an evolving process. Information included in this document is the latest available. We will continue to update this document as more information on the distribution of lecanemab becomes available.
Did the U.S. Food & Drug Administration (FDA) approve lecanemab for the treatment of Alzheimer’s disease?
The FDA has approved the medicine lecanemab (LEQEMBI®) for the treatment of Alzheimer’s disease. This is the first new Alzheimer's drug with full approval in 20 years and one of the first therapies that can slow progression of Alzheimer’s disease, not just treat its symptoms.
What does lecanemab do?
In research, lecanemab has been shown to gradually remove abnormal buildup of the protein, amyloid beta, which is linked to the plaques in the brains of those with Alzheimer’s disease and may cause the disease. In people in the earliest symptomatic stages of Alzheimer’s disease, removal of amyloid appears to slow disease progression symptoms. Lecanemab does not completely stop or reverse Alzheimer’s disease.
Who is lecanemab for?
It is for people in the earliest symptomatic stages of Alzheimer’s disease with confirmed presence of brain amyloid beta plaques. As with any medical treatment, appropriateness depends on a variety of factors.
Who is lecanemab NOT for?
Lecanemab is not for use in individuals in moderate or late stages of Alzheimer’s disease or in any dementia other than Alzheimer’s disease. Lecanemab should not be used in patients diagnosed with other conditions that cause cognitive impairment and dementia (i.e., Lewy body dementia, vascular dementia/stroke, frontotemporal dementia, Parkinson’s disease).
How do I know if lecanemab is right for me or my loved one?
Lecanemab is for people with mild symptoms suggesting Alzheimer’s disease and who have had confirmation of Alzheimer’s disease with testing. Lecanemab will require a prescription. We are currently in the process of evaluating our patients for the appropriateness of treatment.
How does lecanemab work?
Lecanemab is a monoclonal antibody. In our bodies, antibodies “mark” or “label” molecules that need to be removed by the immune system. Normally, these are bacteria, viruses and toxins. Lecanemab is manufactured to stick to amyloid beta protein, enabling the immune system to gradually remove the protein from the brain. Lecanemab is delivered via infusion — directly into the vein through a needle or catheter — every two weeks.
Is lecanemab safe?
Like any medication, lecanemab also has side effects. The side effect seen most commonly during the studies was amyloid-related imaging abnormalities (ARIA) — removing of amyloid may cause leakiness of blood vessels and swelling in the brain or bleeding. Regular brain MRI (magnetic resonance imaging) scans are required during treatment with lecanemab to monitor any changes.
When will lecanemab be available for the public?
Managing the complexities of this new medication, including Medicare requirements for coverage, may delay availability for clinical use. Availability for patients will likely start later in 2023.
Will Cleveland Clinic administer lecanemab to patients?
Yes, Cleveland Clinic Lou Ruvo Center for Brain Health locations in Ohio and Nevada will offer medication to current patients with early-stage Alzheimer's disease who qualify. It will be offered in an outpatient setting once it is available.
I am a patient at Cleveland Clinic Lou Ruvo Center for Brain Health. How can I be evaluated for lecanemab?
You can consult with your Center for Brain Health provider about lecanemab during your next scheduled appointment. If you do not currently have an appointment scheduled, please contact us or send a MyChart message if you want more information from your provider about lecanemab or another disease-modifying therapy for early-stage Alzheimer’s disease.
I am NOT a patient at Cleveland Clinic Lou Ruvo Center for Brain Health. How can I be evaluated for lecanemab?
If you are not currently a patient at the Lou Ruvo Center for Brain Health but are interested in being evaluated for Alzheimer’s disease, please ask your current doctor to send a referral to Cleveland Clinic Lou Ruvo Center for Brain Health and then contact us to schedule an appointment with one of our providers.
I am a current patient at the Lou Ruvo Center for Brain Health. Should I make an appointment to come in sooner?
This is a long-term treatment that should not be started lightly. If you have questions about lecanemab prior to your next scheduled neurology appointment, please send your care team a message via MyChart.
Is lecanemab covered by insurance?
Lecanemab is a billable medication. Direct costs to patients will be determined by your insurance plan’s guidelines.
How does lecanemab differ from aducanumab?
Aducanumab (ADUHELM™) is a monoclonal antibody that, to date, has received FDA accelerated approval but not full approval. Cleveland Clinic does not offer it for clinical use at this time. Lecanemab has now received full FDA approval based on evidence of symptomatic effects that were not clearly seen with aducanumab. Both are monoclonal antibodies that target the amyloid beta protein of Alzheimer’s disease, but are not identical, which may explain the difference in effectiveness.
Is aducanumab available at Cleveland Clinic?
Following the FDA’s accelerated approval of aducanumab for the treatment of Alzheimer’s disease in June of 2021, a multidisciplinary panel of Cleveland Clinic experts reviewed all available scientific evidence on this medication and decided not to carry aducanumab. This decision was made based on available data regarding the safety and efficacy of the medication. However, Cleveland Clinic supports continued research in this area, and when additional data become available, we will re-evaluate this medication for use in our patients.
Are there other Alzheimer’s disease research studies?
We have ongoing clinical research studies into potential new treatments; learn more at clevelandclinic.org/clinicaltrials. If you live in Nevada, contact us directly at 702.701.7944 or healthybrains@ccf.org.
