The National Institute for Health and Clinical Excellence (NICE) is approaching the end of a controversial consultation process on proposed radical revisions to its guidelines on drugs for dementia. Since 2001 the institute has recommended that the National Health Service in England and Wales should make the licensed cholinesterase inhibitors donepezil, rivastigmine, and galantamine available to people with mild to moderate Alzheimer's disease.1

NICE guidelines met a hostile reception

Credit: MARK THOMAS

The available research in 2001 could not provide guidance on which patients would respond to these drugs.2 However, when compared with placebo these drugs slowed cognitive decline. Over six months there was an average advantage of 2-3 points on the cognitive section of the Alzheimer's disease assessment scale, which has a range of 70 to 0. Rates of progression vary widely, but the expected average annual decline on this scale in placebo treated patients is 5-6 points.¹² Outside trials the mean annual rate of change is about 8-9 points.3

Carers often report improvements in behavioural disturbances, neuropsychiatric symptoms, motivation, and activities of daily living when their relatives start taking cognitive enhancers but also when they are prescribed placebo. A combination of these features plus cognitive function influence clinicians' global ratings of change, which have usually favoured the active treatments in controlled trials.2