Computerized Antipsychotic Evaluation System

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DESCRIPTION (provided by applicant): Wide-ranging neurocognitive assessment is an integral component of controlled clinical trials of candidate antipsychotic treatments. However, manual administration of large neurocognitive test batteries is inefficient, error prone, and does not meet the needs for standardization across multiple sites. The project objective is to develop an advanced, wide spectrum computerized neurocognitive assessment system that will provide a single, unified platform for comprehensive administration and management of various protocols, sufficient to meet the requirements of a minimum of 75% of controlled clinical trials as well as related research applications. The computerized antipsychotic evaluation system (CAES) will introduce an unprecedented range of content, functionality and utility integration. Advantages include: (a) increased data quality through standardized, multimedia-based administration; (b) integral multimedia-based examiner training for all tests; (c) automated project reporting and documentation; (d) automated patient tracking and scheduling; (e) automated protocol compliance; (f) reduced examiner requirements and errors; (g) automatic generation and tracking of CRFs; (h) automated electronic database transfer and (i) correspondingly reduced costs. The computer platform is uniquely suited to assessment of impaired subjects due to its interactive, dual-display and control architecture that integrates a human examiner, enabling precise control of every step of the administration process for any test. An examiner can score verbal report and overt behavioral performance in real time, an important capability not available in the current generation of single-display systems. The CAES dual-monitor architecture will be implemented on an advanced cognitive assessment platform (ACAP) hardware device, providing comprehensive electronic patient response capture and conferring portability. To ensure relevance of the assessment instrument set, as well as system functions for application in clinical trials, development will be guided by a steering committee of recognized authorities in the field of schizophrenia research, including members of the NIMH-sponsored CATIE (Clinical Antipsychotic Trials in Intervention Effectiveness) consortium. The technical utility, concurrent validity and acceptability of the CAES test instruments and examiner training module (ETM) will be determined in a multicenter study.