It is absolutely great news that Pfizer and BioNTech have brought a vaccine for COVID-19 from discovery to approval by the US Food and Drug Administration just today. We all can see the promise of “normal” on our collective horizon and almost breathe a collective sigh of relief. We have been more than a bit distracted by COVID-19 for how long…ten or more months? And what used to be the major concern of everyone with an older loved one can now get some press. And there may be good news in the Alzheimer’s fight as well.
A company called Cassava Sciences has shared results from a Phase 2b clinical trial that show its therapy helps to block a protein that triggers brain inflammation and the loss of neurons. They are moving to Phase 3 trials on patients who have been diagnosed with Alzheimer’s Disease. The drug is called sumifilam, and it is an oral medication that can be taken once a day. The Phase 2b study focused on how oral administration in a range of dosing could block the proliferation of a protein called HMGB1 that causes inflammation in the brain. The same drug also helps to restore both the shape and function of a beneficial protein in the brain called filamin A, and while it is doing that it also is strengthening the natural defenses of brain by blocking access across the blood brain barrier of inflammatory proteins like albumin.
In more straightforward lay terms, this tablet can help manage three pathways by which Alzheimer’s disease can negatively impact the brain. Part of the evidence the scientists presented to get approval to move forward with a Phase 3 clinical trial focused on some of these biomarkers of harm to the brain. Simifilam also showed a reduction of Ptau-181, the “tau tangles” that are a physical characteristic of Alzheimer’s as well as improved performance on cognitive tests.
As this promising therapy rolls out with a Phase 3 trial across a number of sites in Arizona and Florida among patients with mild to moderate Alzheimer’s Disease who are 50 to 85 years of age, I will keep you informed of findings. You also can follow any reports to the public by going to a government site for clinical trials related to Alzheimer’s. Spoiler alert – there are nearly 1,300 trials currently in motion on some aspect of Alzheimer’s Disease. We will keep you posted on anything truly noteworthy coming from any of these trials so you don’t have to work on your doctorate in biochemistry to decipher what the reports tell us.
So, please consider this two doses of good news on the medical front this week. And when it comes to clinical trials, please remember that the two key tests the FDA applies are that a treatment or vaccine is safe and effective…in that order. Please do not be sucked down the rabbit hole of those who suggest otherwise. Just Google thalidomide…FDA withheld approval of that therapy when the European Medicines Agency signed off.
Charlotte Bishop is an Aging Life Care Advisor, 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. She also is the co-author of How Do I Know You? A Caregiver’s Lifesaver for Dealing with Dementia.