Cognitive testing in early phase clinical trials: Outcome according to adverse event profile in a Phase I study

Abstract

Background: It has been proposed that objective cognitive testing provides additional information to that collected via adverse event (AE) recordings. However, in clinical trials of compounds with potentially negative effects on cognition, the results of cognitive testing may overlap with AE recordings. Aims: To examine cognitive function in subjects who do and do not report sedation-related AEs in a Phase I clinical trial. Methods: Five computerized cognitive tasks were administered to 28 healthy male volunteers enrolled in a simulated Phase I study using midazolam to induce sedation-related AEs and cognitive dysfunction. For each subject, the magnitude of cognitive change between pre-dose ..