Computerized Early Dementia Assessment System

电脑化早期痴呆症评估系统

• 批准号: 7482842
• 负责人: JAMES P O'HALLORAN
• 金额: $ 61.94万
• 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/7482842
• 关键词: Address; Advisory Committees; Alzheimer' s Disease; Architecture; Auditory; Behavior; Behavioral; Categories; Censuses; Certification; Class; 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; Evaluation; Exclusion Criteria; Goals; Health Maintenance Organizations; Healthcare; Healthcare Systems; Human; Impaired cognition; Information Technology; Instruction; Intervention; Interview; Language; Letters; Manuals; Materials Testing; Memory; Methods; Monitor; Multimedia; Nature; Online Systems; Paper; Participant; Patients; Performance; Phase; Population; Process; Protocols documentation; Public Health; Purpose; Qualifying; Range; Rate; Records; Reporting; Research; Research Infrastructure; Research Personnel; Research Project Grants; Sampling; Schedule; Score; Screening procedure; Security; Sensitivity and Specificity; Services; Site; Small Business Funding Mechanisms; 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; cognitive function; cohort; commercialization; computerized; computerized data processing; cooperative study; cost; data acquisition; data management; field study; foreign language; inclusion criteria; instrument; member; mild neurocognitive impairment; neuroimaging; normal aging; pre-clinical; response

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）：人们越来越认识到，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特征。检测 AD“临床前”阶段（包括“正常衰老”和轻度认知障碍 (MCI) 之间的微妙区别）最敏感和最具体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都采用纸质形式的成熟测试（听觉言语学习测试（AVLT）、线索制作、类别流利度等）。然而，通过一系列纸质表格和套件进行的多方面认知评估效率低下、容易出错，并且不能满足跨多个站点的标准化需求。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 NIA 资助的阿尔茨海默氏病神经影像计划 (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多功能平台以及一个严格排除 MCI 受试者的大型规范数据库。该项目的目标是开发计算机化早期痴呆评估系统 (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。一个大型规范数据库（N=600）将根据不同地域的受试者样本进行编制，以匹配全国人口普查的人口构成并满足严格的纳入和排除标准。由于先进的交互式双显示和控制架构集成了人工检查员，CEDAS 将具有独特的能力对老年受试者进行广泛的测试，从而能够精确控制管理过程的每一步。在测试期间，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，从而实现单显示系统上不可能实现的测试的计算机化。 CEDAS 还将托管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、大型队列跟踪，并整合基于人群的流行病学研究的筛选和招募过程。先进的 CEDAS 实用程序还将包括： (a) 针对所有测试的基于多媒体的综合考官培训； (b) 自动化项目报告和文件记录； (c) 自动患者入组跟踪和安排； (d) 全面的多语言支持； (e) 基于网络的综合服务，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 的开发将由该领域主要权威机构的咨询委员会（包括 ADCS 仪器委员会主席）指导。公共健康相关性：CEDAS 将提供一种高效的计算机化方法，对早期 AD 进行敏感且具体的认知评估。 CEDAS 规范数据库将是同类数据库中最大的，对于区分正常衰老与“临床前”AD 至关重要。 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。灵活的计算机化电话评估模块的集成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。