Assorted_Pills_Alzheimer'sLast November, Eli Lilly abandoned its leading Alzheimer’s drug after recent failures during clinical trials. It’s not that the drug didn’t fulfill its mission of clearing out plaques in the brain; the problem was that plaques were removed but patients experienced no relief from their symptoms.

Shortly after Lilly’s drug failed, a “small company called Accera touted an alternative: a drug to improve how the brain processes sugar.”1 Accera’s hypothesis marks an alternative to the longstanding theory that a buildup of a toxic protein called amyloid causes Alzheimer’s disease. Plaques formed by the protein were thought to kill nerves and lead to confusion, memory loss, etc. Unfortunately, Accera’s drug suffered the same fate as Lilly’s. Outcomes did not improve for any participants in their study involving 413 volunteers, Accera announced two weeks ago.2

Multiple drugs from a variety of companies continue failing, and now some of the dominant theories behind the cause of Alzheimer’s are being called into question. An MIT Technology Review article cited that a 2014 review study found more than 99% of 413 different Alzheimer’s drugs tested showed no benefits for patients.3 These failures are forcing researchers and drug developers to rethink Alzheimer’s disease altogether; what the majority once theorized to be the cause has not held up during clinical trials. Lon Schneider, director of the California Alzheimer’s Disease Center at the University of Southern California School of Medicine, fears that drug companies strive to “hit a home run too fast” when “we don’t quite have the illness or target down.”1

Accera and others plan to continue pursuing the alternative theory that “plaques associated with Alzheimer’s develop when the brain starts losing its ability to metabolize blood sugar, or glucose, a key energy source for cells.”1 2017 and beyond will certainly bring about new hypotheses to test and novel mechanisms of action if new drugs continue to fail during clinical trials. If your company is initiating a human study and needs IRB support or help navigating the regulatory pathway for the development of a new drug, please contact our team of experts today.