Aducanumab (Aduhelm™) has received accelerated approval as a treatment for Alzheimer’s disease from the U.S. Food and Drug Administration (FDA). This is the first FDA-approved therapy to address the underlying biology of Alzheimer’s disease.
It is the first therapy to demonstrate that removing amyloid, one of the hallmarks of Alzheimer’s disease, from the brain is reasonably likely to reduce cognitive and functional decline in people living with early Alzheimer’s.
Approval of this therapy underscores the importance of early detection and accurate diagnosis. We encourage people who are interested in learning more about this treatment, for themselves or a loved one, to have a conversation with their health care provider.
Is aducanumab a cure for Alzheimer’s and all other dementia?
No. Aducanumab is the first drug to address the underlying biology of the disease. According to the FDA, aducanumab reduces amyloid plaques, which is reasonably likely to lead to a reduction in clinical decline due to Alzheimer’s disease.
This could mean more time for individuals to actively participate in daily life, have sustained independence and hold on to memories longer.
Who should take this drug?
Aducanumab is indicated for the treatment of Alzheimer’s disease. Treatment with aducanumab should be initiated in patients with mild cognitive impairment (MCI) or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.
Aducanumab was studied in people living with early Alzheimer’s disease and MCI due to Alzheimer’s who showed evidence of a buildup of amyloid plaques in the brain. There is no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied.
Will this drug restore memories or cognitive function that has been lost?
There is no evidence that aducanumab can restore lost memories or cognitive function.
What is mild cognitive impairment?
Mild cognitive impairment (MCI) is an early stage of memory loss or other cognitive ability loss in individuals who maintain the ability to independently perform most activities of daily living.
What type of diagnostic test is the FDA requiring?
The FDA is not requiring any specific diagnostic test. However, the label says aducanumab is indicated for the treatment of Alzheimer’s, based on reduction in amyloid beta plaques, one of the hallmarks of the disease. This means that a physician should confirm the presence of amyloid plaques in the brain before prescribing this anti-amyloid plaque treatment.
Confirmatory tests like cerebrospinal fluid analysis or amyloid PET imaging should be a part of the diagnostic process to determine eligibility for the treatment.
How do I receive this treatment?
If you or a loved one is experiencing memory changes, the Alzheimer’s Association strongly encourages speaking with a health care provider for a thorough evaluation and diagnosis. Aducanumab may be a treatment option.
How is this drug administered?
Aducanumab is administered intravenously (IV) via a 45- to 60-minute infusion every 4 weeks. Infusion can be done at hospitals or infusion therapy centers.
When will it be available at my doctor?
Now that aducanumab is approved, nationwide distribution and implementation will take some time.
What are the side effects?
The most common side effects include amyloid-related imaging abnormalities (ARIA), headache and fall. Another potentially serious side effect is allergic reaction. ARIA is a common side effect that does not usually cause symptoms but can be serious. It is typically a temporary swelling in areas of the brain that usually resolves over time. Some people may also have small spots of bleeding in or on the surface of the brain with the swelling, although most people with swelling in areas of the brain do not have symptoms. Some may have symptoms of ARIA such as headache, dizziness, nausea, confusion and vision changes.
Can I take this drug with my other medications/supplements?
When considering any treatment, including aducanumab, it is important to have a conversation with your health care provider to ensure you are a candidate for the treatment. This includes taking into account other health conditions, medications or supplements.
How will COVID-19 impact my ability to get this treatment?
Throughout the pandemic, our health care systems have adapted. People have continued to receive treatments, including infusions such as chemotherapy, with extra precautions such as social distancing and wearing a mask. Talk to your doctor to find out if aducanumab is right for you or a loved one, and discuss a plan to identify extra precautions for COVID safety.
It's a new day in the fight to end Alzheimer's
Approval of aducanumab is a milestone in the treatment of Alzheimer's. Current progress in science is significant, and we expect this will be the first of a number of treatments to come. Learn more.
ALZ Talks: New Advancements in Alzheimer’s Treatments
Our 30-minute webinar about aducanumab features Dr. Salloway and Dr. Edelmayer reviewing what the treatment is, how it is administered, what it was designed to do, who is eligible to receive it and steps for accessing it. The Alzheimer's Association also offers support and resources for more information.