Identifying Problematic Subjects Entering Clinical Trials in Early Alzheimer’s Disease

In this retrospective analysis we have tested the performance of 3 risk factors - alone and in combination - to recognize subjects who are likely more severe than required by the protocol. Subjects with screening MMSE scores close to the inclusionary thresholds, with longer screening MMSE interviews and poor performance on confirmatory cognitive scales were 22x more likely to be deemed more severe than the inclusion criteria stipulated at baseline than those subjects who did not have any of the 3 risk factors. This finding is important as it allows researchers to identify and possibly screen fail these subjects before they get randomized, thus preserving the integrity of the clinical trial. Among the limitations of this analysis is its retrospective nature and narrow focus, predominantly on MMSE data.