Cognitive testing in early-phase clinical trials: development of a rapid computerized test battery and application in a simulated Phase I study.

Background: Inclusion of cognitive assessment in Phase I trials of novel pharmaceutical agents may help identify subtle yet meaningful CNS effects early in clinical development, and lead to a greater understanding of the pharmacokinetic/pharmacodynamic relationship prior to entering pivotal late-phase trials.

Aims: To examine issues surrounding the inclusion of a computerised cognitive test battery in Phase I clinical trials.

Methods: A 12-minute battery of five computerized cognitive tasks was administered to 28 healthy males in a double-blind, single ascending dose study using three doses of midazolam (0.