Cognitive Go/No-Go decision-making criteria in Alzheimer’s disease drug development

January 21, 2021

Authors: Alette M. Wessels, Chris J. Edgar, Pradeep J. Nathan, Eric R. Siemers, Paul Maruff, John Harrison

Journal: Drug Discovery Today

DOI: 10.1016/j.drudis.2021.01.012

Year Published: 2021

Go/No-Go decision making in early phase clinical trials is challenging for drug developers working in Alzheimer’s disease. Recent negative trial results have been attributed to a lack of efficacy and important safety concerns. Furthermore, demonstrated target engagement has rarely translated into demonstrable clinical efficacy. Cognitive data might provide valuable insights at various points during drug development, and a thoughtful and robust set of decision-making criteria, specified a priori, can and should be applied under many circumstances. This review provides insights into how to utilize cognitive data for Go/No-Go decisions, with an emphasis on how these cognitive criteria differ depending on the context (e.g., stage of development, mechanism of action and trial design).

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