Computerized Activities of Daily Living System

描述(申请人提供)：阿尔茨海默病(AD)是一种中枢神经系统退行性疾病，影响美国65岁以上所有老年居民的4%-6%，每年给美国经济造成的相关损失超过1000亿美元。新疗法的研究和开发至关重要地依赖于准确和可靠的评估方法。对常见日常生活能力的评估是在受控、赞助的临床试验中评估阿尔茨海默病新疗法的重要组成部分。阿尔茨海默病日常生活量表合作研究活动(ADLI)是为评估新的AD治疗方法而开发的第一个综合ADL工具，在所有抗痴呆新药的临床试验中应用了87%以上。一个同等的计算机化版本的ADLI将立即广泛应用于旨在减少阿尔茨海默病认知缺陷和潜在神经病理的受控临床试验和新药物的相关研究方案。 第二阶段的目标是完成先进的计算机化ADLI系统的开发，该系统能够在患者接触点获取数据，并包括一套用于实施和管理AD临床试验的实用程序，以及相关的研究方案。将发展考官管理和自我管理两种模式。为了最大限度地提高各种环境下的应用能力，将支持三种计算机平台：台式机、笔记本电脑和平板电脑。计算机化ADLI(CADLI)系统的优势包括：通过标准化管理、自动报告和文档、与患者跟踪和日程安排的自动链接、自动方案遵从性、减少审查员要求和错误、自动生成和跟踪CRF、自动电子数据库传输和降低成本来提高数据质量。除了软件完成，第二阶段将在人类受试者中实施连续研究，以优化自我管理形式，并在领先的AD研究中心确定标准ADLI和计算机化ADLI的纵向同时有效性。拟议的新系统将提供有史以来第一个用于临床试验的计算机化ADL仪器和第一个自我管理版本。最终的验证版本将符合FDA、HHS和HIPAA的专门法规和指南。

DESCRIPTION (provided by applicant): Alzheimer's Disease (AD) is a degenerative disorder of the central nervous system that affects between 4-6% of all elderly US residents over the age of 65, with annual associated costs to the US economy of over $100 billion. Research and development of new treatments is critically dependent on accurate and reliable assessment methods. Assessment of common daily living skills is an essential component of evaluation of new treatments for Alzheimer's disease in controlled, sponsored clinical trials. The Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADLI) is the first comprehensive ADL instrument developed for the purpose of evaluating new AD treatments and is applied in over 87% of all clinical trials of new antidementia pharmacologic agents. An equivalent, computerized version of the ADLI would find immediate, widespread application in controlled clinical trials and related research protocols of new pharmaceutical agents aimed at reducing the cognitive deficits and underlying neuropathology of Alzheimer's disease. The objective of Phase II is to complete the development of an advanced computerized ADLI system capable of acquiring data at the point of patient contact and that includes a suite of utilities for implementation and management of AD clinical trials, as well as related research protocols. Both examiner-administered and self-administered modes will be developed. To maximize application capability in a variety of settings, three computer platforms will be supported: desktop, notebook and tablet PC. Advantages of the computerized ADLI (cADLI) system include: increased data quality through standardized administration, automated reporting and documentation, automated linkage to patient tracking and scheduling, automated protocol compliance, reduced examiner requirements and errors, automatic generation and tracking of CRFs, automated electronic database transfer and reduced costs. In addition to software completion, Phase II will implement consecutive studies in human subjects to optimize the self-administered form and determine longitudinal concurrent validity of the standard ADLI with the computerized ADLI at a leading AD research center. The proposed new system will provide the first ever computerized ADL instrument for clinical trials and first self-administered version. The final, validated version will comply with specialized FDA, HHS and HIPAA regulations and guidelines.