Dear Dr. Michelle,
Is it true that there is a new treatment for Alzheimer’s disease that slows it down?
This is a question I’ve been asked repeatedly over the past month. The most recently approved medication for Alzheimer’s disease is Biogen’s aducanumab (Aduhelm). The FDA approved this drug in June of 2021, even though scientific advisors to the FDA cautioned against approval. Aduhelm is currently available by prescription, but Medicare will only cover costs if the patient is enrolled in an ongoing clinical trial that the FDA has required as part of its conditional approval of the drug. I don’t know of many doctors who are prescribing it to patients who are paying out of pocket.
Aducanumab is a monoclonal antibody (“-mab” drug) that targets amyloid, the sticky plaque that builds up in the brain of people with Alzheimer’s disease. This past September, Eisai released findings about their “-mab” drug lecanemab, showing that it slows both cognitive decline and amyloid plaque build-up in people with early Alzheimer’s. Eisai is discussing these data with authorities and a response from the FDA is expected in January 2023. Other “-mab” drugs that we are sure to hear more about in the near future are Roche’s gantenerumab and Eli Lilly’s donanemab. Both companies will be presenting some of their latest results at the upcoming Clinical Trials on Alzheimer’s Disease conference later this month.
In order to be approved as a disease-modifying treatment for Alzheimer’s disease, the data will have to show that by getting rid of amyloid plaque and stopping it from forming, two things happen: 1) thinking skills are better preserved; and, 2) the disease doesn’t spread as quickly throughout the brain.
Monoclonal antibodies are generally administered by IV infusion or injection. An increased risk of brain swelling and bleeding is one of the more concerning possible side effects. In most cases, these side effects have not led to serious consequences, but careful monitoring is necessary. Additional reservations about the “-mabs” are the costs, not just of the drugs themselves, but the tests, procedures, and specialized staff needed to safely administer them. These concerns are valid, but so are the risks and costs associated with not having a medication to slow decline.
As new treatments for Alzheimer’s disease become potential new realities, so will the difficult issues that come along with them. How will these drugs become available to the very large number of people who will need them? Who will pay for the medications and associated procedures? How will we train enough specialists to feel comfortable prescribing these drugs, monitoring patients, and orchestrating the process?
These are big challenges institutionally and globally, but also signify tremendous progress in Alzheimer’s drug development. Even if clearing amyloid is not a sole cure for Alzheimer’s, it may be the next monumental step towards a “cocktail” of drugs needed to battle this debilitating disease. One thing is certain, hope is on the horizon even if it comes with new quandaries.
*Michelle Papka, Ph.D. is the Founder of The Cognitive and Research Center of New Jersey (The CRCNJ) in Springfield, NJ. The mission of The CRCNJ is to provide no-cost diagnostic, treatment and supportive resources through clinical research opportunities to people affected by Alzheimer’s disease and other cognitive disorders.
