|This is a 13 month study that does not involve medication for patients with Alzheimers disease. Participants will take a series of computerized tests as well as paper and pencil tests to assess to their cognitive functioning. |
|What is the objective of this study? ||The project objective is to develop a computerized version of the Alzheimer's Disease Assessment Scale (cADAS) that is equivalent to the standard paper-and-pencil ADAS (sADAS). The ADAS is a measurement tool used to determine change in cognitive function. The 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 is uniquely suited to assess the elderly and impaired subjects due to its interactive dual-display and control architecture which integrates a human examiner. This enables an examiner to score verbal report and overt behavioral performance (e.g. praxis tasks), otherwise not possible with single display systems. To determine concurrent validity, Phase II will implement a longitudinal comparison of the cADAS with the standard ADAS. |
|What does participation in this study involve? |
|Memory and performance tests; ADAS plus standard mini-mental status exam. This study does not involve medication. |
|How will the study be conducted? |
Phase II will implement a longitudinal (13 month) study in which the standard paper-based ADAS will be compared to the computerized ADAS (cADAS). In this study, approximately 4 computerized assessments and 3 standard ADAS assesssments will be performed per patient. Subjects meeting inclusion criteria will be evaluated on seven occasions each over a period of approximately 13 months. Total ADAS scores and subscores will be compared by means of the intraclass correlation coefficient.
A full scale, long term validation study will be conducted to determine the degree of relationship between the sADAS and cADAS over 12 months, a period of time in which significant change in patient function, as a result of disease progression, or its inhibition by treatment is known to occur. The Alzheimer's Disease Cooperative Study (ADCS) has mandated that new or revised cognitive assessment batteries intended for application in AD clinical trials undergo validity assesssment a minimum of one year. Demonstrating the longitudinal ability to accurately track changes, or lack of changes, in relation to the sADAS is essential if the cADAS is to be accepted by the pharmaceutical industry for AD clinical trials.
|How many patients will be participating in the study? |
|A total of 50 patients will be recruited for the study with 12 patients from USC. |
|Who is eligible to participate in this study? |
|Patients with mild to moderate Alzheimer's disease; may be on a cholinesterase inhibitor |
|How can I enroll in this study? |
|This study is currently enrolling volunteers. If interested, please contact: |
Randall Sanabria, Margaret Villa, R.N.
University of Southern California Keck School of Medicine