Computerized Early Dementia Assessment System

电脑化早期痴呆症评估系统

• 批准号: 7586831
• 负责人: JAMES P O'HALLORAN
• 金额: $ 51.13万
• 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 2011-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7586831
• 关键词: Address; Advisory Committees; Alzheimer' s Disease; Architecture; Auditory; Behavior; Behavioral; Categories; Censuses; Certification; Clinic; Clinical; Clinical Trials; Cognitive; Complex; Computer Architectures; Computer Assisted; Computer Interface; Computer Systems Development; Computer software; Computers; Controlled Clinical Trials; Data; Databases; Dementia; Development; Devices; Distributed Databases; Documentation; Drug Industry; Early Diagnosis; Effectiveness; Effectiveness of Interventions; Elderly; Electronics; Enrollment; Ensure; Epidemiologic Studies; Epidemiology; Evaluation; Exclusion Criteria; Goals; Healthcare; Healthcare Systems; Human; Impaired cognition; Information Technology; Instruction; Interview; Language; Letters; Manuals; Materials Testing; Memory; Methods; Monitor; Multimedia; Nature; Online Systems; Paper; Participant; Patients; Performance; Phase; Process; Protocols documentation; Qualifying; Records; Reporting; Research; Research Infrastructure; Research Personnel; Research Project Grants; Sampling; Schedule; Screening procedure; Security; Sensitivity and Specificity; Services; Site; Small Business Innovation Research Grant; Software Validation; Solutions; Source; Speed; Staging; Standardization; System; Tablets; Telephone; Testing; Time; Trail Making Test; Training; Translating; Verbal Learning; Voice; authority; base; clinical application; clinical practice; cognitive function; cohort; commercialization; computerized; computerized data processing; control trial; cooperative study; cost; data acquisition; data management; field study; flexibility; foreign language; inclusion criteria; instrument; meetings; member; mild neurocognitive impairment; neuroimaging; normal aging; population based; pre-clinical; public health relevance; response; successful intervention

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.

描述（由申请人提供）：越来越多的人认为，阿尔茨海默病（AD）的成功干预和治疗依赖于能够可靠检测到的最早阶段认知功能下降的表征。检测AD的“临床前”阶段（包括“正常衰老”和轻度认知障碍（MCI）之间的细微区别）的最敏感和特异性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都使用纸质形式的成熟测试（听觉言语学习测试（AVLT），连线，类别流畅性等）。然而，通过一系列纸质表格和工具包进行的多方面认知评估效率低下，容易出错，并且不能满足多个地点标准化的需求。这些测试的计算机化版本很少应用于AD研究或临床试验。即使在目前由美国国家情报局赞助的阿尔茨海默病神经影像学倡议（ADNI）中，所有46个中心都使用纸质版本。这些测试的计算机化版本的广泛接受将需要一个通用的平台以及严格排除MCI受试者的大型规范数据库。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），提供一套最广泛接受和应用的认知测试，足以满足至少75%的对照临床试验以及相关研究的要求。一个大型规范性数据库（N=600）将在与全国人口普查的人口构成相匹配并符合严格的纳入和排除标准的地理多样性受试者样本中进行汇编。CEDAS将独特地能够在老年受试者中进行广泛的测试，这是由于先进的交互式双显示器和控制架构，该架构集成了人类检查员，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。CEDAS还将拥有一个先进的、计算机辅助的电话评估模块，该模块将支持具有成本效益的远程评估、大型队列跟踪，并整合基于人口的流行病学研究的筛查和招募过程。CEDAS的先进实用程序还将包括：（a）对所有测试进行综合的、基于多媒体的检查员培训;（B）自动化项目报告和文件编制;（c）自动化患者登记跟踪和时间安排;（d）全面的多语种支持;（e）综合网络服务，包括自动化电子数据库传输。为了确保评估组合的相关性以及系统功能在对照试验、多中心研究项目或临床实践中的应用，CEDAS的开发将由该领域领先权威机构的咨询委员会指导，包括ADCS仪器委员会主席。公共卫生关系：CEDAS将提供一种高效的计算机化方法，对早期AD进行敏感和特异的认知评估。CEDAS规范性数据库将是同类数据库中最大的，并且对于区分正常老化和“临床前”AD是非常必要的。CEDAS将应用于临床试验和广泛的研究，以寻找早期阿尔茨海默病的治疗方法。整合灵活的计算机化电话评估模块将提供早期评估的相关手段以及筛选和跟踪AD临床试验和大规模流行病学研究参与者的自动化手段。