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）：已经越来越接受的是，对阿尔茨海默氏病（AD）的成功干预和治疗取决于最早可靠发现的认知功能下降的表征。检测AD的“临床前”阶段的最敏感和具体方法，包括“正常衰老”和轻度认知障碍（MCI）之间的微妙区别（MCI）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利用基于纸张的良好测试形式（听觉语言学习测试（AVLT），TRAIL制作，类别流利度等）。但是，通过基于纸张的形式和套件的阵列进行的多方面认知评估效率低下，容易出错，并且不满足多个站点的标准化需求。这些测试的计算机版本很少用于AD研究或临床试验。即使在当前由NIA赞助的阿尔茨海默氏病神经影像倡议（ADNI）中，所有46个中心都使用纸版本。对这些测试的计算机版本的广泛接受将需要一个多功能平台以及一个大型的规范数据库，该数据库严格排除了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评估系统（CEDAS），该系统提供一组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。大型规范数据库（n = 600）将在与国家人口普查的人口统计学组成并满足严格的包容和排除标准的受试者的地理样本中汇编。由于先进的，互动的，双分解和控制体系结构，CEDA将具有独特的能力在老年人受试者中进行广泛的测试，从而整合了人类检查员，从而可以精确控制管理过程的每个步骤。在测试会话中，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进行评分，以及公开的行为性能，从而实现单个播放系统上无法进行测试的计算机化。 CEDA还将举办一个高级，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，并整合基于人群的流行病学研究的筛查和招聘过程。高级CEDAS公用事业还将包括：（a）所有测试的基于多媒体的积分，基于多媒体的检查员培训； （b）自动化项目报告和文档； （c）自动化的患者入学跟踪和调度； （d）全面的多语言支持； （e）基于Web的集成服务，包括自动化电子数据库传输。为了确保评估电池的相关性以及在对照试验，多中心研究项目或临床实践中应用的系统功能，CEDAS开发将受到该领域领先当局的咨询委员会的指导，包括ADCS仪器委员会主席。公共卫生相关性：CEDA将提供一种高效，计算机化的方法，用于对早期AD进行敏感和特定的认知评估。 CEDAS规范数据库将是同类数据库中最大的数据库，并且要区分正常衰老和“临床前” AD。 CEDA将应用于临床试验和广泛的研究，以在早期找到阿尔茨海默氏病的治疗方法。柔性，计算机化的电话评估模块的整合将提供相关的早期评估手段，以及在临床试验中筛选和跟踪参与者的自动化手段和AD大规模流行病学研究。