Using Prior Success to Improve Alzheimer Trials, Drug Development: Jeffrey Cummings, MD, ScD

WATCH TIME: 4 minutes

"If we don’t have to do imaging, don’t have to do lumbar punctures, and can measure the progression of the disease and the effect of the drug through plasma biomarkers, we will be much better positioned in terms of being able to accelerate drug development."

A 2021 research paper authored by Jeffrey Cummings, MD, ScD, and colleagues estimated the cumulative expenditures to fund Alzheimer disease (AD) clinical trials over the past quarter-century and highlighted the numerous failed attempts that continue to plague the field. Overall, excluding the recent approval of aducanumab (Aduhelm; Biogen), there have only been 5 drugs—all for symptomatic treatment only—that have achieved FDA approval for AD since 1995. An estimated $42.5 billion in private expenditures has been sunk into AD clinical trials since then, with phase 3 representing the highest stage for costs of research and development ($24.1B).

Despite its controversial development history, the FDA greenlighting aducanumab–the first approval since 2003–was mostly seen as a success for the space. The drug was approved under the accelerated approval pathway, which is a relatively new construct that allows the drug to hit the market while developers continue to demonstrate its efficacy through post-marketing phase 4 studies.

Cummings, the director of the Chambers-Grundy Center for Transformative Neuroscience at University of Nevada, Las Vegas, sat down with NeurologyLive® to discuss how the clinical community can learn from drug successes like aducanumab. He detailed the clinical significance of biomarker assays and gave future call-to-action on how AD trials can improve going forward.