Computerized Early Dementia Assessment System

描述(由申请人提供)：越来越多的人接受，阿尔茨海默病(AD)的成功干预和治疗依赖于在能够可靠地发现的最早阶段对认知功能下降的特征。检测AD“临床前”阶段，包括“正常衰老”和轻度认知损害(MCI)之间的细微差别，最敏感和最特异的方法是通过多方面的认知评估。目前，大多数多中心研究和对照试验采用纸质形式的成熟测试(听觉语言学习测试、连线测试、类别流利性测试等)。然而，通过纸质表格和工具包阵列进行的多方面认知评估效率低、容易出错，并且不能满足跨多个站点的标准化需求。这些测试的计算机化版本很少被应用于AD研究或临床试验。即使在目前由NIA发起的阿尔茨海默病神经成像倡议(ADNI)中，所有46个中心都使用纸质版本。广泛接受这些测试的计算机化版本将需要一个通用的平台和一个大型的标准数据库，严格排除患有MCI的受试者。该项目的目标是开发一个计算机化的早期痴呆症评估系统(CEDAS)，提供一套最被广泛接受和应用的认知测试的主集，足以满足至少75%的受控临床试验和相关研究的要求。一个大型规范数据库(N=600)将以符合全国人口普查人口构成并符合严格的纳入和排除标准的不同地理范围的对象样本进行汇编。CEDAS将独一无二地能够管理老年科目的各种测试，这是因为一个先进的、互动的双显示和控制架构集成了一名人类考官，能够精确控制管理过程的每一步。在测试过程中，考官可以“暂停”、重复(或补充)数字化指令，对简单和复杂的口头报告以及公开的行为表现进行评分，从而实现单显示器系统不可能实现的测试的计算机化。CEDAS还将拥有一个先进的计算机辅助电话评估模块，该模块将支持具有成本效益的远程评估、大规模队列跟踪，并整合以人口为基础的流行病学研究的筛选和招募过程。高级CEDAS实用程序还将包括：(A)针对所有考试的综合多媒体考官培训；(B)自动项目报告和文件编制；(C)自动病人登记跟踪和日程安排；(D)综合多语种支持；(E)综合网络服务，包括自动电子数据库传输。为了确保评估电池以及系统功能在对照试验、多中心研究项目或临床实践中应用的相关性，CEDAS的开发将由包括ADCS仪器委员会主席在内的该领域主要权威机构组成的咨询委员会指导。公共卫生相关性：CEDAS将提供一种高效的、计算机化的方法，对早期AD进行敏感和具体的认知评估。CEDAS标准数据库将是同类数据库中最大的，是区分正常衰老和“临床前”AD的关键。CEDAS将被应用于临床试验和广泛的研究，以寻找阿尔茨海默病的早期治疗方法。整合灵活的计算机化电话评估模块将提供相关的早期评估手段，以及筛选和跟踪阿尔茨海默病临床试验和大规模流行病学研究参与者的自动化手段。

DESCRIPTION (provided by applicant): It has become increasingly accepted that successful intervention and treatment of Alzheimer's disease (AD) relies on characterization of decline in cognitive function in the earliest stages that can be reliably detected. The most sensitive and specific method of detecting the "preclinical" stage of AD, including subtle distinctions between "normal aging" and mild cognitive impairment (MCI), is through multifaceted cognitive assessment. At present, the majority of multi-center research and controlled trials utilize paper-based forms of well-established tests (Auditory Verbal Learning Test (AVLT), Trail Making, Category Fluency, etc.). However, multifaceted cognitive assessment by arrays of paper-based forms and kits is inefficient, error prone and does not meet the needs for standardization across multiple sites. Computerized versions of these tests have rarely been applied in AD research or clinical trials. Even in the current NIA-sponsored Alzheimer's Disease Neuroimaging Initiative (ADNI), paper versions are used in all 46 centers. Wide acceptance of computerized versions of these tests will require a versatile platform as well as a large normative database that stringently excludes subjects with MCI. The project objective is to develop a Computerized Early Dementia Assessment System (CEDAS) that provides a master set of the most widely accepted and applied cognitive tests, sufficient to meet the requirements of a minimum of 75 percent of controlled clinical trials as well as related research. A large normative database (N=600) will be compiled in a geographically diverse sample of subjects matching the demographic composition of the national census and meeting stringent inclusion and exclusion criteria. The CEDAS will be uniquely capable of administering a wide range of tests in elderly subjects due to an advanced, interactive, dual-display and control architecture that integrates a human examiner, enabling precise control of every step of the administration process. During a testing session, an examiner can "pause", repeat (or supplement) digitized instructions, score both simple and complex verbal report, as well as overt behavioral performance, thus enabling computerization of tests not possible on single-display systems. The CEDAS will also host an advanced, computer-assisted, telephonic assessment module that will support cost-effective remote assessment, large cohort tracking, and integrate the processes of screening and recruitment for population-based, epidemiological studies. Advanced CEDAS utilities will also include: (a) integral, multimedia-based, examiner training for all tests; (b) automated project reporting and documentation; (c) automated patient enrollment tracking and scheduling; (d) comprehensive multilingual support; and (e) integrated web-based services, including automated electronic database transfer. To ensure relevance of the assessment battery as well as system functions for application in controlled trials, multi-center research projects, or clinical practice, CEDAS development will be guided by an Advisory Committee of leading authorities in the field, including the Chair of the ADCS Instrument Committee. PUBLIC HEALTH RELEVANCE: The CEDAS will provide a highly efficient, computerized method of performing sensitive and specific cognitive assessment of early stage AD. The CEDAS normative database will be the largest of its kind and is critically needed for distinguishing normal aging from "preclinical" AD. The CEDAS will be applied in clinical trials and wide-ranging research to find treatments for Alzheimer's disease in the early stage. Integration of a flexible, computerized telephonic assessment module will provide an associated means of early stage assessment as well as an automated means of screening and tracking participants in clinical trials and large scale epidemiological studies of AD.