Neurology

More Information:
Penn Memory Center: Leqembi
Memory Treatment Centers: Leqembi Article

Lecanemab (Leqembi) Approved for Treatment of Early Alzheimer’s Disease

Lecanemab (Leqembi®) is an antibody intravenous (IV) infusion therapy that targets and removes beta-amyloid from the brain. It has received traditional approval from the U.S. Food and Drug Administration (FDA) to treat early Alzheimer’s disease, including people living with mild cognitive impairment (MCI) or mild dementia due to Alzheimer’s disease who have confirmation of elevated beta-amyloid in the brain. Leqembi lowers beta-amyloid in the brain and reduces cognitive and functional decline in people living with early Alzheimer’s.

The treatment will allow people to have more time to participate in daily life and live independently. Individuals should talk with their health care provider to develop an Alzheimer’s treatment plan that is right for them, including weighing the benefits and risks of all approved medications and therapies.

Is lecanemab a cure for Alzheimer’s and all other dementia?

No. Lecanemab is not a cure, but it is the first traditionally 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. 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 mild 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.

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, biofluid (CSF and blood) 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).

Your health care provider will also do a magnetic resonance imaging (MRI) scan before starting treatment with lecanemab. Some people have a genetic risk factor (ApoE ε4 gene carriers) that may cause an increased risk for the side effect of amyloid-related imaging abnormalities (ARIA). The FDA encourages testing for ApoE ε4 status should be performed prior to initiation of treatment to inform the risk of developing ARIA. Prior to testing, doctors should discuss with patients the risk of ARIA and the implications of genetic testing results.

How do I receive this treatment?

If you or a loved one is experiencing memory changes, 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.

Will Medicare cover lecanemab?

The Centers for Medicare & Medicaid Services (CMS) announced they will cover lecanemab as long as an individual’s physician enrolls them in a CMS-approved registry.

Will Medicaid cover lecanemab?

Those eligible for both Medicare and Medicaid — either as a Full Benefit Dual Eligible (eligible for full Medicaid benefits) or in a Medicare Savings Program (Medicaid helping to cover some of the beneficiary’s Medicare costs) — can receive coverage, with Medicaid’s role being to cover the individual’s 20% coinsurance payment. There may be additional requirements at the state level for those eligible for Medicaid and Medicare.

How is this drug administered?

The treatment is administered every two weeks through an IV, lasting about one hour for each infusion. Typically, infusions can be done at hospitals and infusion therapy centers.

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. Lecanemab can cause serious allergic reactions. The most common reported side effects were infusion-related reactions, amyloid-related imaging abnormalities (ARIA) and headache. These are not all of the possible side effects of lecanemab, and 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.