Assessing the clinical importance of statistically significant improvement in anti-dementia drug trials.

A strategy for assessing the clinical importance of statistically significant treatment benefits in recent dementia drug trials is proposed. Traditional criteria for the assessment of valid inferences are helpful: the more likely the treatment effects are valid, the greater the chance that they will be clinically important. The role of the Clinician's Interview-Based Impression of Change is also of some importance. Progress in this area faces the special challenge that the 'new' disease entity of partial treatment of Alzheimer's disease has not been well described. Large, systematic clinical studies of treated patients remain necessary to define reliable guides to successful treatment. Copyright 2001 S. Karger AG, Basel.