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At this time, the NCPA physicians will not be recommending this treatment for any of its patients. Please read below for further clarification and statements from other medical societies.

Aducanumab (Aduhelm), a new medication for Alzheimer’s dementia, has been conditionally approved by the Food and Drug Administration (FDA), as of 6/7/2021. This was approved under an accelerated pathway designed to provide earlier access to medications to treat serious illnesses, even despite uncertainty about clinical benefit.

The limited data available suggests that the effectiveness of this drug is linked to its ability to decrease the amount of a protein called beta amyloid, which has been implicated in the progression of Alzheimer’s disease.

In the two large clinical trials for this medication, known as “ENGAGE” and “EMERGE”, there were conflicting results regarding whether this medication was effective or not. Given this uncertainty, Biogen, the company that produces the drug, will still be required by the FDA to prove that it reduces beta amyloid in the brain, by conducting a “Phase IV” trial, or the approval may be revoked.

Importantly, the drug was also associated with serious risks that were noted in the trials. These included swelling and/or bleeding in the brain and were seen in a significant percentage of patients (10-40%). These will need to be carefully weighed on a case-by-case basis, even if approval is extended.

Finally, there are considerable costs anticipated to be associated with the drug, its monthly infusion and tests that will be required to select appropriate patients and monitor for the development of potentially serious side effects. These are not well-delineated or widely available, and insurance coverage of these costs has yet to be determined.

We, the physicians of the Neurology Center, have agreed that the above-described issues will need to be thoroughly clarified before the drug can be confidently prescribed.

We will continue to follow the evolution of Aducanumab as a therapeutic option for our patients with Alzheimer’s dementia with great hope and interest.

< Read The American Geriatrics Society letter to the FDA (pdf)