A new drug has been approved by the FDA to slow the progression of Alzheimer’s disease in some people in the early stages of the disease. Is lecanemab right for you or your loved one? Here, Kim Johnson, MD, director of Duke's Memory Disorders Program, answers questions about who could benefit from lecanemab, its side effects, and how to be considered for treatment at Duke Health.
What is lecanemab?
Lecanemab (brand name Leqembi) is a monoclonal antibody that targets and removes abnormal proteins called amyloids from the brain. Amyloid build-up is thought to affect cognition and brain function -- things like memory, language, multitasking, managing finances and medications, and more.
Does lecanemab cure Alzheimer’s?
Dr. Johnson stressed that lecanemab is not a cure for Alzheimer’s disease. Rather, it has been shown to slow the progression of cognitive and functional decline by 27% over 18 months in clinical studies.1
“The clinical trial studying lecanemab shows that removing amyloid from the brain can affect the course of the disease by slowing decline," she said.
How is lecanemab given?
Lecanemab is given every two weeks intravenously in an infusion center. It takes about an hour to complete each infusion session. However, you will need to stay longer for observation after your first few infusions.
Who is eligible to receive lecanemab?
Lecanemab is approved for people who met the following criteria:
- Ages 50 to 90 years old.
- Symptoms of mild cognitive impairment or very early mild dementia due to Alzheimer’s disease
- Evidence of amyloid accumulation in the brain. This must be detected by either a lumbar puncture and cerebrospinal fluid analysis, or a specialized positron emission tomography (PET) scan of the brain.
Who is not a candidate for lecanemab?
Lecanemab is not approved for people with moderate or severe symptoms of dementia due to Alzheimer’s disease or people who have Lewy body dementia, frontotemporal dementia, vascular dementia, or Parkinson’s dementia. It is not appropriate for people who take strong blood thinners or have a history of stroke or seizure, brain abnormalities, hypersensitivity to monoclonal antibody treatment, bleeding disorders, immune conditions, or other serious health conditions.
What are the possible side effects of lecanemab?
The most common side effect of lecanemab is a temporary reaction to the infusion. Symptoms include fever, feeling flushed, chills, rash, and changes in blood pressure. These are usually not severe and may be easily treated.
Amyloid-Related Imaging Abnormalities (ARIA)
ARIA is a serious side effect that may result in brain swelling and/or brain bleeding. Brain swelling occurred in about 13% of clinical trial participations, and brain bleeding occurred in about 17% of participants. Of those, about one in five people experienced symptoms of headache, vision changes, and confusion -- others had no symptoms. People taking lecanemab must undergo periodic brain MRIs to monitor for ARIA. Most cases of ARIA resolve within a few months.
“Depending on MRI results and your symptoms, your doctor may recommend continuing treatment or taking a break for a while. In other cases, it might be too risky, and you’ll need to stop treatment altogether,” Dr. Johnson said.
People who have a specific gene variation called the “APOE4 allele” are at a higher risk of developing ARIA. Genetic testing for the APOE4 allele is required before starting lecanemab.
How much will lecanemab cost?
The cost for lecanemab treatment is partially covered by Medicare, but individual out-of-pocket expenses will depend on your Medicare plan. For you to receive Medicare coverage, your physician must participate in a clinical registry designed to collect real-world information about the medication. Related costs, including required imaging scans and other tests, are not covered by Medicare or private insurances right now. Other insurance carriers are still updating their coverage plans, so please contact your insurance provider with questions about your coverage.
How can I receive lecanemab?
Receiving lecanemab involves an infusion treatment every two weeks and periodic MRI scans of your brain to monitor for side effects like ARIA. You can travel to Duke every two weeks for the infusion treatments and the MRI scans or you can opt to receive these services closer to home.
If you or your loved one are experiencing mild cognitive symptoms and are interested in undergoing a cognitive evaluation at Duke to see whether you are a candidate for lecanemab, please complete the following form.