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 over $100 billion. Research and development of new treatments is critically dependent on accurate and reliable assessment methods that address multiple cognitive domains, thus requiring batteries of tests. The Alzheimer's Disease Assessment Scale or ADAS was among the first comprehensive cognitive/behavioral batteries designed specifically for Alzheimer's disease assessment and is today the most widely accepted and used in research and clinical trials of new antidementia pharmacologic agents. The overall goal is to develop, a computerized version of the ADAS that is equivalent to the paper-and-pencil version while conferring the advantages of contemporary information technologies. An equivalent, computerized version would be useful for implementing clinical trials and research protocols. The primary advantages of computerization include: standardized presentation, immediate electronic data capture, error-free tabulation and scoring; and storage in a powerful, fully relational database. The computer platform to be utilized is uniquely suited to assessment of the elderly and impaired subjects due to its interactive dual display and control architecture which integrates a human examiner. This enables the examiner to score verbal report and overt behavioral performance (e.g. praxis tasks), otherwise not possible with single display systems. The proposed hardware-software ensemble would include not only a computerized ADAS but a suite of software utilities to assist implementation and management of clinical trials and to comply with new FDA guidelines.
The proposed new technology would find application in clinical trials as well as research and development of new pharmaceutical agents aimed at reducing the cognitive deficits and/or underlying neuropathology of Alzheimer disease. The integration of flexible support and administrative utilities will support a range of experimental drug development and assessment protocols. The system may also find application in clinical settings for routine performance evaluations.
