Randomized, placebo-controlled clinical trials in Alzheimer’s disease (AD) typically assess changes in cognition, function, and global measures over a short period of time. While this design fits with goal of demonstrating symptomatic benefits of an anti-AD treatment, the differences in objectives for modern trials assessing disease-modifying effects raises questions about the suitability of current trial designs. Samuel Dickson, PhD, Pentara Corporation, Millcreek, UT, talks on the issues created by designing studies for disease modifying treatments using the symptomatic treatment paradigm. To demonstrate disease modification, clinical trials must show that disease trajectory has been altered through action on the underlying pathophysiology. Currently, instruments used in disease-modifying trials and symptomatic trials are the same and thus, efforts are ongoing to modernize trials, incorporating biomarkers and novel endpoints to better assess the potential of an agent to modify the course of Alzheimer’s disease. This interview took place at the Alzheimer’s Association International Conference® (AAIC) 2023 in Amsterdam, Netherlands.
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Sam Dickson is a Senior VP of Pentara Corporation, a company which consults with dozens of companies in the Alzheimer’s space, including Eisai, Biogen, Lilly, and Nutricia.