AD2000 trial

The Alzheimer's Society has expressed serious concern at the interpretation of a new study into the effectiveness of drugs for dementia, published in The Lancet on Friday 25 June 2004.

Authors of the AD2000 study, which was led by the University of Birmingham clinical trials unit, claim that their research shows donepezil (Aricept) has little benefit for people with Alzheimer's disease and that it is not cost-effective.

The Alzheimer's Society strongly disagrees with these claims. Its director of research, Professor Clive Ballard, says:

'We are very disappointed with the interpretation of the AD2000 study by the authors and would be concerned if the findings were to further restrict access to drug treatments that we know can delay the symptoms of Alzheimer's disease. The Alzheimer's Society recently undertook the largest ever consumer survey of drugs for dementia as part of its submission to NICE. Of the 2,672 responses from people with experience of taking these drugs, 73 per cent said they worked.'

The AD2000 study started as an attempt to complete a large pragmatic trial of donepezil that was independent of pharmaceutical companies. However, the study recruited less than 30 per cent of the intended participants. As a consequence, the study did not have the adequate statistical power to look at some of the main outcome measures, such as the number of people moving into institutional care.

Professor Clive Ballard:

'Over the past seven years, evidence from people with dementia and their carers has proved that cholinesterase inhibitors such as donepezil are effective, not as a cure for Alzheimer's, but for slowing the worsening of symptoms and improving quality of life for some people. NICE has also approved these treatments as clinically- and cost-effective on the basis of a large number of rigorous clinical trials. It is extremely important that the results of this single trial do not lead to the withholding of important treatments for the many people with Alzheimer's disease who benefit from them.'

'We obviously want better treatments and there is a lot of research going on to develop these better treatments, but at the moment these are the best treatments we have.'

'The Alzheimer's Society accepts a very small proportion of funding from pharmaceutical companies under very strict guidelines which doesn't directly influence policy in any way.'