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.
