New Alzheimer’s Medications Available at Duke
What You Need to Know About Lecanemab and Donanemab
Two new drugs have been approved by the FDA to slow the progression of Alzheimer’s in some people in the early stages of the disease. Are these drugs 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 and donanemab, their side effects, and how to be considered for treatment at Duke Health.
What are amyloid-targeting treatments?
Amyloid-targeting treatments (also known as ATTs) seek out and remove an abnormal protein called amyloid beta from the brain. Buildup of this protein in the brain can lead to the problems with memory and thinking that are seen in Alzheimer’s disease. Lecanemab (brand name Leqembi®) and donanemab (Kisunla™) are two examples of amyloid-targeting treatments.
Do amyloid-targeting treatments cure Alzheimer’s disease?
Dr. Johnson stressed that lecanemab and donanemab are not cures for Alzheimer’s disease. However, these drugs have been shown to modestly slow worsening symptoms of Alzheimer’s disease.
“The clinical trials studying lecanemab and donanemab show that removing amyloid from the brain can modestly slow decline in memory and thinking and help people living with Alzheimer’s disease remain independent for longer," she said.
How are amyloid-targeting treatments given?
Lecanemab and donanemab are both given intravenously at an infusion center. Lecanemab is administered every other week, and donanemab is given once a month.
Who is eligible to receive amyloid-targeting treatments?
Lecanemab and donanemab are approved for people who meet the following criteria:
- Confirmation of early Alzheimer’s disease. This includes people with mild cognitive impairment or very early dementia due to Alzheimer’s disease. These treatments work better in people with milder symptoms and may not help people with more advanced symptoms.
- Confirmation that memory and thinking changes are due to Alzheimer’s disease. Alzheimer’s disease is diagnosed with a lumbar puncture and cerebrospinal fluid testing, or a specialized positron emission tomography (PET) scan of the brain.
Who is not a candidate?
Lecanemab and donanemab are not approved for people with moderate or severe symptoms of dementia due to Alzheimer’s disease or people with other causes of memory and thinking changes like Lewy body disease, frontotemporal disease, or Parkinson’s disease. People who take blood thinners or who have a history of stroke, seizure, brain abnormalities, hypersensitivity to monoclonal antibody treatment, bleeding disorders, immune conditions, or other serious health conditions may be at increased risk of serious side effects.
What are the possible side effects?
Infusion Reactions
The most common side effect of lecanemab and donanemab is a temporary reaction to the infusion. Symptoms include fever, feeling flushed, chills, rash, and changes in blood pressure. These are usually mild.
Amyloid-Related Imaging Abnormalities (ARIA)
ARIA is a serious potential side effect that can result in swelling in the brain and/or small areas of bleeding in the brain. Usually there are no associated symptoms, so patients routinely undergo brain MRIs to detect problems early. Most cases of ARIA resolve within a few months.
With lecanemab, brain swelling occurred in about 13% of clinical trial participants, and brain bleeding occurred in 17%. With donanemab, brain swelling occurred in about 24% of clinical trial participants, and brain bleeding occurred in 31%. Of those who experienced swelling in the brain, about one in five had symptoms, including headache, vision changes, and confusion. While the risk of ARIA is higher with donanemab, the risk of serious side effects is similar between the two drugs.
“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 genetic variant called APOE-E4 are at a higher risk of developing ARIA. Genetic testing for the APOE-E4 variant is required before starting lecanemab or donanemab.
How much will lecanemab or donanemab cost?
The cost for lecanemab and donanemab 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, may not be fully covered by Medicare or private insurers. Please contact your insurance provider to determine whether lecanemab or donanemab are covered.
How can I receive lecanemab or donanemab?
If you or your loved one are concerned about early Alzheimer’s disease and want to learn more about these treatments, please request a consultation at Duke.
