COMPUTERIZED ALZHEIMER'S DISEASE CLINICAL INTERVIEW SYSTEM Project Summary and Abstract Wide-ranging behavioral and psychiatric assessment is an integral evaluation component of dementia treatment development and research. At present, approximately 95% of all behavioral and psychiatric data collected in dementia clinical trials and research is recorded using paper forms, imposing numerous fundamental inefficiencies and costs. Although computerized utilities exist for various post-acquisition components such as enrollment, scheduling and tracking, all of these require a stage of manual transcription from paper source documents, creating the need for on-site monitoring. No integrated system exists that achieves direct capture of primary data, nor have any of the multitude of interviews and rating scales for AD trials and research been computerized. Moreover, the collective ergonomic requirements for face-to-face administration and multiple forms of data input (e.g. written text, analog scales, check boxes) impose formidable, unresolved technical demands. The project objective is to develop an enterprise class system for comprehensive computerized implementationof interview-based behavioraland psychiatric assessments in clinicaltrials andresearchof new treatments for Alzheimer's disease. The Computerized Alzheimer's Disease Clinical Interview System (CADCIS) will utilize tablet PCs to replace paper forms with full-size, """"""""smart"""""""" electronic forms in face-to-face clinicalratinginterviews,achieving immediateelectronic capture, thus eliminating subsequent error-pronesteps of manualdatatranscription and transfer (e.g., CaseReport Form creation and management) and costlyon-site data processing. The CADCIS will provide a Master Set (inclusive of >90% of all current protocols) of established evaluation instruments selected by a steering committee of recognized authorities in the field of AD/dementia research, including the Director of the NIMH-sponsored CATIE-AD consortium and leading members of the NIA-sponsored Alzheimer's Disease Cooperative Study (ADCS). Advanced data processing, reporting and management utilities will greatly simplify multicenter research. Integral rater training modules will provide on-demand orientation and certification for all instruments in the master set. Integrated virtual private network and wireless technologies will enable a range of automated data transfer and secure communication functions. The technical utility, acceptability and management capabilities of the system will be established in multicenter studies at leading AD/dementia research centers. The CADCIS will be integrated with a computerized dementia assessment system (CEDAS, currently under development (R43 AG026402-01) that includes widely-applied cognitive assessment instruments such as the Alzheimer's Disease Assessment Scale (ADAS). Conjunctively, the CADCIS and CDAS will provide a unified solution for comprehensive computerized assessment of AD and related dementias. The proposed development will result in a new type of highly integrated technology for computerized clinical evaluations of Alzheimer's disease and related dementia research. The CADCIS will find immediate application in clinical trials of new treatments as well as research settings. NeuroComp Systems, Inc. (c) The proposed development will result in a new type of highly integrated technology for computerized clinical evaluations of Alzheimer's disease and related dementia research. The CADCIS will find immediate application in clinical trials of new treatments as well as research settings.
