A Review of Aduhelm, the New FDA-Approved Drug for Alzheimer’s
By Dr. Catherine Madison, Neurologist, Seniors At Home
The recent FDA approval of a new Alzheimer’s drug, aducanumab (Aduhelm) is being widely discussed and we wanted to help our community better understand this new potential treatment. It is important to note this is the first approval of an Alzheimer’s medication since 2003. While the number of persons with an Alzheimer’s process in this country has increased to over 6 million, the striking 99% failure rate of Alzheimer’s drugs has been even more frightening.
What is it and how does it work?
Aducanumab is an antibody that when infused into the body can remove the sticky protein plaques of amyloid that accumulate early in the brains of Alzheimer’s patients. This type of therapy has been studied over the last 25 years with continued disappointments including lack of benefit (despite the removal of the abnormal protein) and unacceptable side effects. With each new attempt, the approach has been varied slightly and the evidence supporting aducanumab does appear a bit better. In some patients early in the course of this illness, there was slightly less decline – meaning they got worse more slowly. The difference was not enough to meet the typical criteria required for a drug’s approval but was allowed under ‘accelerated’ FDA guidelines given for drugs greatly needed by the population. At least this acknowledges that Alzheimer’s is a fatal illness and might help move other potential treatments forward faster. And the FDA is requiring another study for further support of benefit.
Who can receive it?
No guidelines around who can receive this new medicine have been established yet. The evidence suggests it is most helpful given to people with very mild impairments. As aducanumab removes amyloid, individuals will need a specialized PET scan to prove they have amyloid in their brain before starting treatment.
What are the costs?
Treatment costs are always a factor. While many have already called for Biogen to reduce the $56,000 annual price tag of the monthly infusions, we still need to consider other associated costs such as an amyloid PET scan, monthly infusions, and medical monitoring. Over 1/3 of the patients in the clinical trials had small areas of bleeding in the brain (ARIA) which required missing some doses and ongoing brain imaging with MRI. This is not trivial and needs to weigh heavily in a cost-benefit analysis. How patients, insurance companies, and the government will share these costs has yet to be determined.
What’s next?
The arrival of aducanumab is exciting; however, there is no roadmap to guide treatment decisions. More time and consideration are needed. In the meanwhile, the study to further support aducanumab is gearing up locally and individuals could receive the medication by joining this effort. Thankfully enthusiasm for research continues with more drugs in the pipeline including a seaweed extract that was fast-tracked. In addition, there are ongoing studies reaffirming the benefits of a healthy lifestyle to stave off cognitive decline. Be sure to check in with your provider to see whether you can participate in a trial—in San Francisco, we have the Ray Dolby Brain Health Center and also the UCSF Memory and Aging Center.
We know the incidence of Alzheimer’s is likely reduced by 50% by living a healthy lifestyle we can all adopt:
- A heart-healthy diet with little or no alcohol (search the MIND diet!)
- Regular exercise (150 minutes of cardiovascular activity spread out through the week).
- Keeping the brain stimulated with new learning and maintaining social interactions.
- Getting a good night’s sleep.
We can do all of these things and feel better while new trials make even more treatments available.
Dr. Madison is a board-certified neurologist at Seniors At Home’s Center for Dementia Care. She specializes in supporting older adults and their families as they navigate cognitive impairment and the practical elements of long-term planning with a dementia diagnosis
If you or someone you know has questions or concerns regarding dementia care, reach out to Seniors At Home for a free assessment—415-449-3700.
Seniors At Home is a division of Jewish Family and Children’s Services, a trusted nonprofit institution that has been providing care since 1850. Our services are funded by fees and by donations for those who cannot afford the full cost of care for these critical services.
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