Applied Clinical Trials
Although Biogen's Alzheimer's drug BAN2401 addresses buildup of amyloid plaques, investors and scientists look to reevaluate the plaque theory and search for a glimmer of hope in breakthrough treatments.
Last month’s Alzheimer’s Association International Conference (AAIC) 2018 heralded many announcements, including the mixed reception around Phase II trials results from Biogen’s Alzheimer’s drug BAN2401. Like
many treatments in AD, it addressed build up of amyloid plaques in the brain. However, many drug failures in that area, as well as Pfizer’s exodus from Alzheimer’s and Parkinson’s research early this year, has led to investors and scientists to reevaluate the plaque theory.
In the week prior to AAIC, Bill Gates announced a $30 million “venture philanthropy” fund to develop novel biomarkers for the early detection of Alzheimer’s disease and related dementia. One of the reasons for the shaky AD drug development is the inability to find patients in early stages of Alzheimer’s.
Edward I. Ginns, MD, PhD, medical director, neurology, for Quest Diagnostics, said, “When we see patients at the point of clinical identification, the brain is pretty much out of resources. It’s unlikely that neurons that are dead or non-functional will be treated at that late stage.” To that end, Quest Diagnostics wanted to identify patients with cognition problems earlier. They developed CogniSense, a cognition test that is available as an app for the iPad and given in the primary care doctor’s office. “Physicians need the tools to rule out reversible causes of mild cognitive impairment, and then to be able to refer others out to specialists, when needed,” said Ginns.
With over five million Americans presenting with some kind of cognitive impairment-not just Alzheimer’s-the healthcare system, as well as individual resources, are becoming unsustainable. With CogniSense, the patient can take a baseline test, with results stored in the Quest lab-ordering platform, Care360. Subsequent tests can be ordered to monitor and track a person’s cognitive function, as the information is now part of the patient’s medical record. By coming to cognition from the front-end, there is potential that Alzheimer’s, as well as other cognitive disorders, can be identified and treated earlier, with potential discovery candidates coming from patients’ lab or cognitive data.
In March, the National Institute on Aging and the Alzheimer’s Association released a new framework which proposes that biomarkers, not symptoms, could be used to assess AD for research. While not currently intended for clinical use, this new framework is expected to facilitate better understanding of the disease process and the sequence of events that lead to cognitive impairment and dementia.
Ginns noted when he was an NIH researcher and discovered Gaucher disease, researchers now think, 20 years later, that those with Gaucher are five-times more likely to have affects of Parkinson’s disease. With biomarker and early identification taking a lead in the form of the NIH framework and Bill Gates’ influence, as well as developments in current Alzheimer’s drugs, and through collaborations, Ginns hopes Alzheimer’s science speeds up. While it appears early on that BAN2401 wasn’t the spark needed for Alzheimer’s research, Ginns is convinced once there is a breakthrough, that glimmer of hope, it will truly open up development on many levels-diagnostics, clinical care, and medications.