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

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).

Automated summary

Making Go/No-Go decisions in early phase clinical trials for Alzheimer's disease drugs is challenging due to recent negative trial results linked to lack of efficacy and safety concerns. Demonstrated target engagement rarely translates to clinical efficacy, highlighting the importance of cognitive data for decision making criteria in drug development, varying based on the context like stage of development, mechanism of action, and trial design.