Samuel Dickson, PhD, Pentara Corporation, Millcreek, UT, shares his thoughts on how open label extension studies can be used to gather supportive evidence for disease modification hypotheses. The nature of OLEs allows numerous types of hypotheses to be studied. For example, disease modification can be investigated using a pseudo staggered start analysis, comparing patients initially randomized to the investigative agent and those who initially received placebo. If an agent is acting on the underlying disease course and these benefits accumulate over time, the slope of the original placebo group will differ from the original active group at the end of the OLE phase. 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.