The recent FDA approval of aducanumab for the treatment of Alzheimer’s disease has left people with a lot of questions. As the first drug authorized to treat Alzheimer’s since 2003, it has given hope to people who have had few treatment options for this devastating disease. However, aducanumab is not a cure for Alzheimer’s disease and it is not for all people with memory loss or Alzheimer’s disease. Here, Duke geriatric psychiatrist Kim Johnson, MD, answers some frequently asked questions about the new drug and how to find out if it might be an option for you.
What is aducanumab?
Aducanumab (brand name Aduhelm) is an intravenous drug that aims to slow the progression of Alzheimer’s disease. It’s given through a vein in a monthly infusion that lasts one to three hours to administer.
How does aducanumab work?
Amyloid is a protein that can build up in the brain and may cause Alzheimer’s disease. Aducanumab travels to the brain, sticks to amyloid, and removes it.
Am I eligible to receive aducanumab?
The clinical trials of aducanumab studied a limited, specific group of people. You may be eligible to receive the drug if you:
- Are younger than 85 years old
- Have confirmed mild cognitive impairment, defined as a mild decrease in memory and/or thinking that occurs daily but does not yet affect functioning
- Have amyloid present in the brain (determined by lumbar puncture or imaging scan)
- Do not have a history of microbleeds, transient ischemic attacks, or stroke due to bleeding (an MRI will be needed to confirm this)
- Do not take blood-thinning medications
What are the possible side effects of aducanumab?
The most common side effects include areas of brain swelling, small brain bleeding, headache, or falls. The areas of brain swelling and small brain bleeding are usually temporary and resolve over time. Everyone who receives aducanumab will have periodic MRIs to monitor for these side effects, which can cause headache, confusion, dizziness, vision changes, or nausea but may not cause any symptoms.
How much will aducanumab cost?
Right now, the cost to patients is unknown. Biogen, the pharmaceutical company that created aducanumab, has set a price of $56,000 per year. Medicare and private insurers are in the process of deciding if and/or how much of that cost they will cover.
When will aducanumab be available?
Aducanumab is not yet available to patients through Duke. Hospitals like Duke review new drugs carefully before offering them to patients. Duke is in the review process now.
Why does there seem to be controversy about aducanumab?
The FDA’s approval of aducanumab is controversial for several reasons.
- Clinical trials studying the effectiveness of aducanumab did not prove that the drug improved cognition. In fact, two trials were stopped early because no clinical benefit was shown. Biogen reviewed the data again and noted a small improvement of symptoms in one subgroup of patients.
- Aducanumab is shown to reduce amyloid in the brain, but it is still unclear whether amyloid causes memory loss or Alzheimer’s disease. Therefore, the direct link between amyloid reduction and improvement of memory loss or other Alzheimer’s symptoms has not been established, and the clinical benefit for memory loss needs to be further explored.
- All but one member of an independent expert panel -- enlisted to review the drug’s effectiveness and make a recommendation to the FDA -- voted against approving the drug.
- The FDA approved aducanumab through an accelerated pathway that is designed to bring the drug to market sooner, compared with the traditional pathway that most drugs take. This accelerated pathway can be used for drugs that treat diseases with no known cure, even if the clinical benefit is unclear and needs more investigation. As part of the accelerated FDA approval, Biogen is required to perform more research studies to answer some important questions related to clinical benefit. Duke plans to participate in these studies.
- The wholesale cost of the drug is high, meaning it could be too expensive for many patients.
How can I find out more about how to receive aducanumab?
If you are already being treated for mild cognitive impairment or Alzheimer’s at Duke, talk to your doctor at your next, regularly scheduled appointment. If you don’t have an appointment scheduled, contact your doctor via MyChart. If you are not an existing Duke patient, ask your primary care provider, neurologist, or memory disorder specialist for a referral to one of our Alzheimer providers.
Duke memory disorders specialists will be hosting informational webinars in fall 2021 to share more information about aducanumab. Check back regularly for updates and to register.