The MATRICS Consensus Cognitive Battery (MCCB) was developed to provide an assessment of cognitive impairment and measure change in clinical trials for Cognitive Impairment Associated with Schizophrenia (CIAS). While pivotal trials are expected to be 24 weeks in duration to characterize the benefit risk of an investigational product to treat (CIAS), earlier clinical studies such as proof of concept (POC) or dose-ranging trials may be of shorter duration. It is therefore important to understand the natural history progression and variability of the MCCB over relatively brief periods of time in order to more confidently design and power early-stage clinical trials. These data will assist in informing early development decision-making in drug development for CIAS. The objective of this analysis was to characterize the time course of the MCCB in placebo subjects with CIAS.
Timothy Nicholas, Vicki Davis, Francois Gaudreault, Brendon Binneman , Nicholas Demartinis, Jessica Y Mancuso, Danny Chen, Alexandra Atkins, Ilise Lombardo, Richard Keefe