Computerized Dementia Assessment System

电脑痴呆症评估系统

• 批准号: 6933952
• 负责人: JAMES P O'HALLORAN
• 金额: $ 23.21万
• 依托单位: NEUROCOMP SYSTEMS, INC.
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-09-01 至 2006-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6933952
• 关键词: Alzheimer' s disease; Internet; aging; clinical research; cognition disorders; computer program /software; computer system design /evaluation; dementia; diagnosis design /evaluation; diagnostic tests; human subject; mental disorder diagnosis; psychological tests

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.

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一个组成部分。然而，需要大量纸质表格和套件的大型测试电池的手动管理效率低下，容易出错，并且不能满足跨多个站点的标准化需求。 该项目的目标是开发一种先进的、广泛的计算机化认知评估系统，该系统将为各种认知评估协议的综合管理和管理提供单一、统一的平台，足以满足至少 75% 的对照临床试验的要求。作为相关的研究方案。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 因其先进的交互式双显示和控制架构（集成了人工检查员）而特别适合对受损受试者进行评估，从而能够精确控制任何测试管理过程的每一步。考官可以对口头报告和明显的行为表现进行评分，从而实现单显示器系统上不可能实现的测试的计算机化。 CDAS 双显示器架构将基于先进认知评估平台 (ACAP) 硬件设备，提供全面的电子患者反应捕获并具有便携性。 CDAS 的优点包括： (a) 通过基于多媒体的标准化管理提高数据质量； (b) 针对所有考试的综合多媒体考官培训； (c) 自动化项目报告和文件记录； (d) 自动患者跟踪和安排； (e) 自动遵守协议； (f) 减少审查员要求和错误； (g) 全面的多语言支持； (h) 自动生成和跟踪 CRF；(i) 基于网络的服务，包括自动电子数据库传输查询解析，以及 (j) 相应降低成本。为了确保评估电池以及系统功能在临床试验中应用的相关性，CDAS 的开发将由痴呆症研究领域领先权威的咨询委员会指导，其中包括 NIMH 赞助的 CATIE-阿尔茨海默病联盟的主任。在第一阶段，CDAS 测试仪器的代表性子集的同时有效性、可靠性和可接受性将在诊断患有阿尔茨海默病的人类受试者样本中确定。