On June 7, 2021, the Food and Drug Administration (FDA) approved aducanumab, marketed under the name Aduhelm™ for the treatment of Alzheimer’s disease. Here at LBDA, we know that raises both excitement and questions for our community, as many people with LBD have at least some Alzheimer’s changes in their brain including amyloid deposition. Thus, aducanumab could potentially offer benefits to people with LBD.
Since there is a lot of buzz about this new treatment, we would like to address some Frequently Asked Questions (FAQs) from our community. As new information becomes available in the coming months, we will update this FAQ to include the latest developments.
What is aducanumab?
It is a newly approved medication for the treatment of Alzheimer’s disease. Aducanumab is administered through an intravenous (IV) infusion every 4 weeks; it is not available in pill form.
Is this drug a cure for Alzheimer’s disease?
No. This medication is not a cure for Alzheimer’s disease or dementia; it does not stop the disease or reverse the damage it has already caused. Aducanumab removes amyloid from the brain, which may result in slowing of clinical progression of Alzheimer’s disease. It is not yet clear if removal of amyloid leads to a clinically meaningful benefit. There was a small degree of clinical slowing over 18 months in one of the two clinical trials of aducanumab, but not in the other one.
Is this drug appropriate for people with LBD?
No. The clinical trials of aducanumab did not specifically include people with LBD. Additional studies are needed to ensure it is safe and effective for people with LBD, who can be very sensitive to some medications. LBDA strongly advocates for the study of aducanumab in those with LBD plus coexisting AD to address both safety concerns and to determine if it is effective in people who have Lewy body disease and Alzheimer’s disease.
How does aducanumab work?
Aducanumab is a man-made antibody that targets a protein called amyloid-beta. Amyloid-beta protein accumulates in the brains of people with Alzheimer’s disease, and it is thought to contribute to the cognitive decline in Alzheimer’s disease and other dementias. Aducanumab helps the immune system to remove the amyloid-beta deposits from the brain. Researchers believe that reducing amyloid-beta plaques may slow cognitive decline, but this has not been convincingly proven.
What are potential side effects of aducanumab?
As with any medication, aducanumab may have side effects; the most common side effect is headache. Because aducanumab helps remove amyloid deposits, there may be an exaggerated immune response in the brain. This may cause brain swelling and/or bleeding in the brain, among other problems. People receiving aducanumab must have periodic MRI scans to monitor for these types of adverse events.
Can anyone with Alzheimer’s disease be treated with aducanumab?
Dementia specialists are the most appropriate type of clinician to prescribe aducanumab at this time. Certain findings on cerebrospinal fluid (CSF) testing, which is done by lumbar puncture, or an amyloid PET scan, is needed to confirm the presence of amyloid plaques in the brain before prescribing aducanumab.
As with any medication, what medication is right for an individual depends on multiple factors. Aducanumab was only studied in people with Alzheimer’s disease in the mild cognitive impairment or mild dementia stage. There is no evidence at this time that it would be effective in the treatment of moderate to advanced Alzheimer’s disease or other types of dementia. Furthermore, there is no evidence at this time that it would prevent the development of dementia in those who may be at risk. Experts recommend it be avoided in people with vascular dementia because of the risk of brain bleeds.
What are the costs associated with being treated with aducanumab?
- Pre-Treatment Testing: A person must first have to undergo tests to confirm they have biological signs of Alzheimer’s disease, via a lumbar puncture (“spinal tap”) or an amyloid PET scan. While Biogen is providing assistance to cover the cost of the measurement of amyloid following lumbar puncture, there will still be out of pocket costs to the patient. Measurement of amyloid with a PET scan would be entirely at the expense of the patient.
- Treatment: If a person is determined to be eligible for treatment, the annual price of Aduhelm as reported by Biogen is $56,000, plus the cost of administering the infusion. Eventually, insurers, including Medicare, will decide whether the drug and its associated diagnostic and monitoring tests should be covered.
- Follow-Up Tests: Periodic safety monitoring with clinicians, MRI scans, etc., will also be necessary.
If I have further questions, should I contact my doctor?
Please note that your doctor may have limited information specifically regarding aducanumab availability in the months following approval, as discussed above. We understand you may have additional questions about the potential of this drug. We will continue to keep you updated as soon as information becomes available, and we thank you for your patience.
Last update: June 28, 2021