Computerized Activities of Daily Living System

描述（由申请人提供）：阿尔茨海默病（AD）是一种中枢神经系统退行性疾病，影响了美国65岁以上老年居民的4-6%，每年给美国经济带来的相关成本超过1000亿美元。新疗法的研究和开发严重依赖于准确可靠的评估方法。日常生活技能的评估是在控制的、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。阿尔茨海默病合作研究活动日常生活量表（ADLI）是第一个为评估新的阿尔茨海默病治疗方法而开发的综合ADL工具，用于超过87%的新型抗痴呆药物临床试验。一个等效的计算机化ADLI版本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学的新药的对照临床试验和相关研究方案中。

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.