Patterns of clinically detectable treatment effects with galantamine: a qualitative analysis

Abstract

The Clinician's Interview Based Impression of Change, plus carer interview (CIBIC-Plus) is widely used in anti-dementia drug trials. It includes clinicians' notes about patients' behaviour, function, and cognition, and a 7-point clinical global impression of change scale that summarizes patients' changes during treatment. We analyzed the narrative content of clinicians' notes from a randomized, controlled trial of galantamine, an anti-Alzheimer's disease drug, and identified varying degrees of improvement and decline. In general, while most patients were rated as showing 'no change', considerable changes were seen in such patients, but were judged by clinicians to have been offset by decline in other areas. Most patients rated as 'improved' showed combinations of cognitive, functional and/or behavioural improvement or stability. While patients with signs of cognitive improvement could be found across the scale from 'very much improved' to 'minimally worse', patients with functional improvement were rated as having improved or not having changed. Cognitive declines in several domains or any cognitive decline seen with functional declines were the chief drivers of worsening ratings. The CIBIC-Plus notes have potential value in identifying reproducible patterns of clinically relevant treatment effects provided that data are consistent and specific, and that seemingly contradictory information is carefully explored. Clinicians appear to be skeptical of cognitive changes not supported by like changes in function or behaviour.