The most promising Alzheimer’s drug, Aducanumab, did not get approved by the FDA to move to the next phase of approval. There was not sufficient evidence that it actually showed improvement in Alzheimer’s patients. This Time Magazine article explains what happened and next steps.
I can’t tell you how disappointed I was about this. I have several friends who have Early Onset Alzheimer’s who participated in the trial for this drug and they indicated that they believed it was helping. I was very hopeful. The the last six weeks I participated in the Talk Nerdy Conference (sponsored by the Alliance for Aging Research) with doctors and researchers for many different medical conditions, including Early Onset Alzheimers. We have several presentations regarding Aducanumab from researchers who were involved in developing the drug and the trials. They indicated that the trials were not indicating that the drug was showing the improvement that they had hoped for and they were concerned that it would not be approved to go forward with the FDA. They indicated that they were hoping that they will get additional approval and funding to go back and tweak/make improvements to the drug so indeed it would show improvement. Then on Friday, the FDA advisory committee recommended that the drug now go forward. The Alzheimer’s Association is vowing to fight this decision.
Quite frankly, I cried on Friday night when I found out. According to my neurologist it is the only drug on the horizon that potentially could have helped those of us with Alzheimer’s and dementia. Today, I participated in another Talk Nerdy Conference today where a FDA person presented. I asked them specifically about this drug and what happened last Friday. She indicated that there were concerns about the safety about this drug. She also said that often the FDA does not issue a “hard no” and because this is the only potential drug that can help Alzheimer’s patients, they may allow the researchers to continue their efforts to improve the drug and show that it will not cause health problem. Apparently there will be another hearing before next March 2021.
I have been disappointed that I do not qualify to participate in any clinical trials due to several of my medical conditions and also because I have a pacemaker. I have felt like I am missing out. My friends tell me that this may be a blessing because I am not participating in something that could also harm me. My neurologist told me this as well. If I partipate in a trial it could trigger cancer somewhere else in my body since I already had cancer. So I’ve decided that I need to not worry, I need to not fret, and just be grateful for those wonderful people who do participate in trials.
I’m done with my little pity party and dissapointment. I woke up today, I have food on my table, a wonderful family and friends, and a rough over my head. I’m going to continue my zest for life and live every moment. I will continue to pray everyday that they find a cure but I can’t let disappointment every time a drugs fails to consume me. I have a fantastic life, and am decent health and still am able to function cognitively the majority of the time. I am going to keep blogging, and stay active in the Alzheimer’s community because it has opened doors for me that I would never had if I was just sitting home and being quiet. For that I am grateful.
Not today, Alzheimer’s, not today!