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CTAD 2023 | Measuring treatment effect in Alzheimer’s disease clinical trials: the ‘time saved’ approach

Guoqiao Wang, PhD, Washington University School of Medicine, St Louis, MO, introduces the concept of ‘time saved’ as a measure of treatment effect in Alzheimer’s disease (AD) clinical trials. This innovative approach typically employs a backward projection to placebo method to quantify the ‘time saved’ as the time difference between equal placebo and intervention effects and the study endpoint. Dr Wang suggests that this method, in comparison to traditional primary endpoints like CDR-SB (clinical dementia rating-sum of boxes), may offer easier interpretation. However, he emphasizes that the ‘time saved’ approach has its limitations, including the potential for misinterpreting treatment effects, disruption of the randomization equilibrium, and the omission of the absolute difference between placebo and treatment effects. Dr Wang introduces potential alternative approaches that may overcome some of these limitations, including the backwards projection to treatment decline (BPT) method and the additional time needed to reach placebo decline (ATNRP) method. This interview took place at the CTAD 2023 conference in Boston, MA.

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Guoqiao Wang is the biostatistics core co-leader for the DIAN-TU and supported by fundings from NIH/NIA, Alzheimer’s Association, Eli Lilly and Company, F. Hoffman-LaRoche Ltd., Avid Radiopharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, GHR Foundation, an anonymous organization. Cogstate and Signant offered in-kind support. He reports serving on a Data Safety Committee for Eli Lilly and Company and statistical consultant for Alector, Inc.