Neuropsychological assessment in clinical trials of Alzheimer disease.
A fundamental problem in research aimed at developing and testing new treatments for Alzheimer disease (AD) is determining drug efficacy. At the present time, while there are no biological markers for diagnosing or assessing this disease, investigators must rely on clinical judgment and neuropsychological outcome measures to determine if and when a new treatment may be beneficial. The following article provides an overview of the issues involved in conducting a clinical trial in AD when measures of cognitive and behavioral changes are used. It is based on the proceedings from an international workshop on this topic that was convened by the National Institute on Aging in January 1990.