A randomised, blinded, placebo-controlled trial in dementia patients continuing or stopping neuroleptics

Apr 1 2008

Results of a randomised trial published in PLoS Medicine show no benefit in cognitive or neuropsychiatric outcomes from continuing neuroleptic drugs in patients with Alzheimer's disease.

The researchers, led by Clive Ballard from King's College hospital, London, recruited 165 patients from across the UK who were already being treated with neuroleptic drugs. They randomised half of the patients to continue treatment and half to discontinue treatment. At 6 and 12 months the patients that remained in each group were assessed for their cognitive status and neuropsychiatric symptoms. The researchers found that there were no differences between the two groups in terms of cognitive decline. They also found no overall differences between the two groups in the change in the number of neuropsychiatric symptoms. Patients with severe neuropsychiatric problems at the outset of the trial may have had some benefit from continued neuroleptic therapy, but this difference was not statistically significant.

Almost all older dementia patients will have some neuropsychiatric symptoms. These symptoms can include agitation, aggression, and psychosis. Neuroleptics (sometimes called antipsychotics) are the class of drugs often used to manage or control neuropsychiatric problems, but there have been questions about their safety and appropriateness. Safety concerns, in this group of patients especially, are an increased risk of stroke, parkinsonism, sedation, edema, and chest infections. There may also be a worsening of cognitive decline with prolonged use of neuroleptics.

The findings in the patients studied here do not indicate any benefit of continuing neuroleptic therapies in older patients with dementia. However, the numbers of patients studied in this trial is small. More studies are urgently needed to improve the management of these patients.

Citation: Ballard C, Lana MM, Theodoulou M, Douglas S, McShane R, et al. (2008) A randomised, blinded, placebo-controlled trial in dementia patients continuing or stopping neuroleptics (the DART-AD Trial). PLoS Med 5(4): e76.

http://www.plos.org/