Q & A: Key information about the new Alzheimer’s disease drug Aduhelm

Last June, the FDA granted accelerated approval to aducanumab, which is marketed under the name Aduhelm. It’s the first new medication to treat Alzheimer’s disease that has been approved since 2003. Here are answers to some of the most common questions about this new treatment.

Q: How does Aduhelm treat Alzheimer’s disease?

A: The brains of people who are living with Alzheimer’s have abnormal build-ups of proteins in and around brain cells. One of the proteins, which forms plaques around the brain cells, is called amyloid. The other protein, tau, creates tangles within brain cells. The build-up of these proteins interrupts the brain cells’ ability to send messages to each other. Over time, areas of the brain shrink, affecting memory, language skills, thinking, and personality and behavior.

This new medication targets and breaks down the amyloid plaques. It’s a monoclonal antibody that stimulates the immune system, which then breaks down the plaques.

Q: Does the medication reverse the effects of Alzheimer’s?

A: No. It doesn’t reverse the progression of the disease in people who already have symptoms, such as memory loss or thinking and reasoning problems. It is expected to slow the progression of the disease in people in the earlier stages of Alzheimer’s, although that has not yet been definitively shown in clinical trials. What the trials did find is that the drug breaks down the amyloid plaques in the brain.

Q: Who is a candidate for treatment with Aduhelm?

A: The FDA-approved labeling for Aduhelm says it should be given only to people with mild cognitive impairment or mild dementia. The clinical trials for the drug only included people with very early stage Alzheimer’s. Before being prescribed the medicine, patients will need to have an MRI, PET scan, or another type of imaging that shows a build-up of amyloid plaques in the brain.

Q: How is the drug given?

A: It is an intravenous infusion given once a month at an infusion center. Each infusion takes about an hour and a half to two hours.

Q: What are the potential side effects of Aduhelm?

• 21% of people in the double-blind, randomized, placebo-controlled dose-ranging studies experienced headaches.
• Approximately 15% of the trial participants experienced falls while taking the medication.
• Approximately 40% of the people who received this medication in the clinical trials had swelling in the brain during the first four months of treatment. This swelling usually cleared up on its own over time. Most of them experienced no symptoms related to the swelling. Those who did have symptoms reported headache, confusion, delirium, altered mental status, disorientation, dizziness or vertigo, visual disturbance, and nausea.
• About 25% had bleeding in the brain or on the brain’s surface. In most cases, the bleeds were small and did not cause significant symptoms, but some trial participants did experience serious effects from the swelling or bleeding.
• To date, there has been one patient death associated with Aduhelm, although the case is still under review.

Q: How much does the medication cost and is it covered by insurance?

A: The current list price is $28,000 a year. Everyone interested in Aduhelm should talk with their insurer to find out if the cost is covered and what their out-of-pocket cost will be because not all insurers cover this medication. Medicare recently proposed that coverage for the drug should be limited to people taking part in approved clinical trials. That preliminary decision was based on the agency’s conclusion that, after reviewing the clinical evidence, significant doubts remained about whether the benefits of Aduhelm outweigh the risks.

If you or a family member has been diagnosed with mild cognitive impairment or the early stages of dementia and you’re interested in learning more about Aduhelm, talk with your doctor. A health advisor can also provide evidence-based information about this medication and other treatment strategies for people living with cognitive impairment and Alzheimer’s disease.