Computerized Dementia Assessment System

描述（由申请人提供）：多方面的认知评估是候选抗痴呆治疗的对照临床试验以及广泛的研究方案的组成部分。然而，需要纸质表格和试剂盒阵列的大型测试组的手动管理效率低下，容易出错，并且不满足跨多个站点的标准化需求。 该项目的目标是开发一个先进的，广谱的计算机化认知评估系统，将提供一个单一的，统一的平台，用于各种认知评估协议的综合管理和管理，足以满足至少75%的对照临床试验以及相关研究协议的要求。计算机化痴呆症评估系统（CDAS）将引入前所未有的测试内容，功能和集成范围。CDAS独特地适合于评估受损受试者，因为其先进的交互式双显示器和控制架构集成了人类检查员，能够精确控制任何测试的管理过程的每一步。考官可以对口头报告和明显的行为表现进行评分，从而使单显示器系统无法实现的测试计算机化。CDAS双显示器架构将基于高级认知评估平台（ACAP）硬件设备，提供全面的电子患者反应捕获和便携性。CDAS的优势包括：（a）通过标准化的多媒体管理提高数据质量;（B）对所有测试进行综合的多媒体检查员培训;（c）项目报告和文件自动化;（d）病人跟踪和时间安排自动化;（e）遵守协议自动化;（f）减少检查员要求和错误;（g）全面的多语种支持;（h）自动生成和跟踪CRF;（i）网上服务，包括自动电子数据库转移查询解决办法，以及（j）相应减少费用。为了确保评估电池的相关性以及在临床试验中应用的系统功能，CDAS的开发将由痴呆症研究领域的主要权威机构组成的咨询委员会指导，包括NIMH赞助的CATIE-Alzheimer病联盟的主任。在I期，将在被诊断患有阿尔茨海默病的人类受试者样本中确定CDAS测试仪器的代表性子集的并行有效性、可靠性和可接受性。

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. 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.