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AAIC 2023 | Efficient use of open label extension data

Suzanne Hendrix, PhD, Pentara Corporation, Salt Lake City, UT, comments on the efficient use of open label extension (OLE) data to support disease modification hypotheses for investigational Alzheimer’s disease (AD) therapeutics. For example, a pseudo staggered start analysis can be used to demonstrate disease modification if the treatment groups differ at the end of the OLE phase and do not converge during the OLE. This supports the effect of the treatment on the underlying disease course, since the benefit of earlier treatment remains over time. This interview took place at the Alzheimer’s Association International Conference® (AAIC) 2023 in Amsterdam, Netherlands.

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Suzanne Hendrix is owner and CEO of Pentara Corporation, a company which consults with dozens of companies in the Alzheimer’s space, including Eisai, Biogen, Lilly, and Nutricia.