Clinical Trials in Alzheimer’s Disease

The database of the Consortium to Establish a Registry for Alzheimer’s Disease (CERAD) is a seminal work in the field of cognitive dysfunction and Alzheimer’s disease. This 24-center study of 1,094 patients with Alzheimer’s disease who received no treatment for their cognitive dysfunction and 463 normal control subjects is rich in neurobehavioral data and contains extensive imaging and neuropathologic findings. However, the Alzheimer’s Disease Assessment Scale (ADAS) was not administered as part of the CERAD study, which limits the study’s applicability to modern drug trials, in which the ADAS-cognitive subsection (ADAS-cog) is a popular end point. The purpose of this investigation was to develop a derived ADAS-cog score from the neurobehavioral data obtained from subjects during their evaluation in the CERAD study. Two calculated ADAS-cog scores were developed. The first was based on clinically mapping the items on the ADAS-cog to assessments that were performed in the CERAD study. The second was based on rescaling the Mini-Mental Status Exam (MMSE), using published results correlating the ADAS-cog to the MMSE. Standard characteristics of both calculated ADAS-cog scores were calculated and compared with each other and with the literature. Both calculated ADAS-cog scores performed comparably to published characteristics of the ADAS-cog. The clinically based calculated ADAS-cog outperformed the rescaled MMSE. Using the CERAD database, it is now possible to model the progression of an untreated (placebo) population of patients with Alzheimer’s disease and correlate it to a study using ADAS-cog.