Computerized Dementia Assessment System

Neurocomp Systems, Inc., Irvine CA

Investigators

Abstract

[unreadable] DESCRIPTION (provided by applicant): Multifaceted cognitive assessment is an integral component of controlled clinical trials of candidate antidementia treatments as well as a wide range of research protocols. However, manual administration of large test batteries requiring arrays of paper-based forms and kits is inefficient, error prone and does not meet the needs for standardization across multiple sites. [unreadable] [unreadable] The project objective is to develop an advanced, wide spectrum computerized cognitive assessment system that will provide a single, unified platform for comprehensive administration and management of various cognitive assessment protocols sufficient to meet the requirements of a minimum of 75% of controlled clinical trials as well as related research protocols. The Computerized Dementia Assessment System (CDAS) will introduce an unprecedented range of test content, functionality and integration. The CDAS is uniquely suited to assessment of impaired subjects due to its advanced, 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, enabling computerization of tests not possible on single-display systems. The CDAS dual-monitor architecture will be based on an advanced cognitive assessment platform (ACAP) hardware device, providing comprehensive electronic patient response capture and conferring portability. CDAS 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) comprehensive multilingual support; (h) automatic generation and tracking of CRFs;(i) web-based services, including automated electronic database transfer query resolution, and (j) correspondingly reduced costs. To ensure relevance of the assessment battery as well as system functions for application in clinical trials, CDAS development will be guided by an advisory committee of leading authorities in the field of dementia research, including the Director of the NIMH-sponsored CATIE-Alzheimer's disease consortium. In Phase I, The concurrent validity, reliability and acceptability of a representative subset of the CDAS test instruments will be determined in a sample of human subjects diagnosed with Alzheimer's disease. [unreadable] [unreadable]