The big splash on the medical news this past week gratifyingly was not COVID-19, but instead an approval of a new Alzheimer’s treatment by the FDA. If you have been following any of the news on this new drug we have difficulty pronouncing, aducanumab, you may be scratching your head a bit. I’ve asked one of our senior people, Steve Steiber, Ph.D., to explain this new drug and what is going on in the “Alzheimer’s space” generally, because Dr. Steiber has over 30 years doing market research in the biopharma arena. He’s been published in JAMA, American Journal of Public Health, Public Opinion Quarterly and more and he has a book, Measuring and Managing Patient Satisfaction, in its second edition. He also is my co-author of How Do I Know You? A Caregiver’s Lifesaver for Dealing with Dementia.
I am happy to share with you my take on aducanumab, the Alzheimer’s treatments that preceded it, the controversy that surrounds aducanumab and also how much research into an effective Alzheimer’s treatment is still going on right now. Medical practitioners have been using biologic agents to treat conditions for a very long time if you count insulin, human growth hormone, thyroxine and other “naturally-occurring” body hormones. Aducanumab is a novel biologic, however, that works to interrupt the formation of beta amyloid plaque in the brain. You may recall reading about one of the ways that Alzheimer’s disease is diagnosed is by assessing the accumulation of plaque in the brain through PET imaging. But let me start with what we have had available to treat Alzheimer’s prior to the approval of aducanumab.
Prior to aducanumab, FDA had approved five drugs to slow the progression – but not cure – Alzheimer’s:
- Aricept (donepezil) is able to claim that it can slow the cognitive progression of Alzheimer’s and modestly improve confusion, memory and awareness.
- Exelon (rivastigmine) claims to address the memory loss of both Parkinson’s and Alzheimer’s.
- Namenda (memantine) claims to treat the moderate to severe confusion of Alzheimer’s disease, but it is to be used in combination with one of the other agents.
- Namzaric (donepezil and memantine) combines an extended release form of Namenda as well as Aricept in one pill to address the symptoms each addresses individually.
- Razadyne (galantamine) claims to improve the ability to think and even remember by increasing brain levels of acetylcholine, a beneficial enzyme.
None of these treatments could reverse or halt the progression of Alzheimer’s disease, and they really only modestly slowed its progression. The last of these was approved by the Food and Drug Administration in 2003. It had been a very long time since anything new has broken on the scene to address the ravages of Alzheimer’s disease when aducancumab and Biogen presented their case to the FDA committees seeking approval. It would be charitable to say that this new treatment offered mixed results at best in two Phase 3 clinical trials on patients with the disease.
Phase 3 is the trial that builds on early research in animals and later humans to test against placebo whether a therapy can show a statistically significant improvement over placebo on specific predetermined clinical outcomes called clinical endpoints. Biogen halted both its phase 3 studies, called Engage and Emerge, early when they assessed that aducanumab was not likely to meet its clinical endpoints (“clinical endpoints” are the pre-established goals that a study proposes to meet in order to be deemed successful). In subsequent analysis, Biogen found that the Engage study, in fact, did not meet its endpoints, but Emerge showed some positive outcomes. Generally, this kind of analysis after the fact is not accepted by FDA, and FDA also takes a pretty dim view of one study’s success offset by another study’s failure. Nonetheless, FDA gave its conditional approval to Biogen. The condition was to be a phase 4 clinical trial to settle some of the questions on efficacy. You can go to your financial news feed to see that Biogen’s stock shot up 39%, so this is a big deal…but the deal is not over.
In my next post to Charlotte’s Blog I’ll be sharing with you more of what FDA has demanded of aducanumab going forward, some of the organizational fallout at FDA, and also why we might still be hopeful. I’ll share with you some details on more than a dozen other companies who are moving forward with their clinical trials on therapies that show tangible promise in the fight against Alzheimer’s disease. I’ll also share the sites you can visit to gather more information on all clinical trials currently underway as well as where you can go to see how you can help your loved one apply to be part of some of these clinical trials that show promise if you are a caregiver to someone with Alzheimer’s. It gets interesting.
I encourage you to also send any questions you have to email@example.com . I’ll do my best to provide answers in my next post…part two.
Charlotte Bishop is a Caregiver Coach, an Aging Life Care Advisor, a Geriatric Care Manager and founder of Creative Care Management, certified professionals who are geriatric advocates, resources, counselors and friends to older adults and their families in metropolitan Chicago.