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

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

*Corresponding author for this work

Research output: Contribution to journalReview articleAcademicpeer-review

Abstract

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).
Original languageEnglish
Number of pages7
JournalDrug Discovery Today
Volume26
Issue number5
Early online date2021
DOIs
Publication statusPublished - May 2021
Externally publishedYes

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