New research into the effects of antipsychotic drugs commonly prescribed to Alzheimer's patients concludes that the medication nearly doubles risk of death over three years. The study, funded by the Alzheimer's Research Trust, was led by Prof Clive Ballard's King's College London team and is published in Lancet Neurology on 9 January. 

The study involved 165 Alzheimer's patients in UK care homes who were being prescribed antipsychotics. 83 continued treatment and the remaining 82 had it withdrawn and were instead given oral placebos. 

Findings showed a significant increase in risk of death for patients who continued taking antipsychotic medication. The difference between the two groups became more pronounced over time, with 24-month survival rates for antipsychotic-treated patients falling to 46% versus 71% on the placebo and at 36 months it was 30% versus 59%. It means that after three years, less than a third of people on antipsychotics were alive compared to nearly two thirds using the dummy drug.

Antipsychotics are used to treat symptoms of agitation, delusions and aggressive behaviour. NICE guidelines recommend that the drugs should only be used for short periods of time and where symptoms are severe, and should be very carefully monitored, although in clinical practice the average length of prescription is 1-2 years. While there is evidence of modest short-term (6-12 weeks) benefits of antipsychotic treatment for the serious behavioural symptoms of Alzheimer's, a previous Alzheimer's Research Trust study showed that these benefits were not evident over longer periods of treatment. 

As many as 100,000 people with dementia are routinely prescribed antipsychotics in UK care homes. It could mean 23,500 people dying prematurely, according to a 2008 report by Paul Burstow MP.

Prof Clive Ballard of King's College London said: "The results further highlight the need to seek less harmful alternatives for the long-term treatment of behavioural symptoms in Alzheimer's patients. At the moment, there is still a limited place for antipsychotics in the treatment of Alzheimer's, particularly severe aggression, but the serious concerns of the drugs shown by our research emphasise the urgent need to put an end to unnecessary and prolonged prescribing".

Rebecca Wood, Chief Executive of the Alzheimer's Research Trust, said: "The findings of this research are a real wake-up call and underline the danger of prescribing antipsychotics long-term for anything other than exceptional circumstances. We must avoid the use of these drugs as a potentially dangerous 'chemical cosh' to patients who would be better off without it. The study also highlights the urgent need to develop better treatments as Alzheimer's patients have few options available to them.

"700,000 people in the UK have dementia; we urgently need to fund more research to develop the new treatments we so desperately need".


* Dementia antipsychotic withdrawal trial (DART-AD): long-term follow-up of a randomised placebo-controlled trial by Clive Ballard et al will appear in the Lancet Neurology on Friday 9 January 2009. There was clear evidence of an increase in adverse effects, including parkinsonism, sedation, oedema, chest infections, accelerated decline in brain function, stroke and mortality over 6-12 weeks of treatment with anti-psychotics. The current study emphasizes that the mortality risk becomes much more pronounced with longer term prescriptions. 

* Figures of 100,000 people with dementia routinely prescribed antipsychotics and possible 23,500 dying prematurely taken from Keep Taking the Medicine 4 by Paul Burstow MP, March 2008.

* According to the Department of Health about 200,000 people with dementia are living in nursing homes and a further 250,000 with informal carers.

* Previous ART-funded research into withdrawal of neuroleptics A Randomised, Blinded, Placebo-Controlled Trial in Dementia Patients Continuing or Stopping Neuroleptics (The DART-AD Trial), Clive Ballard et al, April 2008. 

* Background – NHS National Library for Health, Clinical Question and Answer: "What is the best source of guidance available for the use of antipsychotics in the treatment of agitation and restlessness in the elderly"? 

* There are 700,000 people with dementia in the UK today, a number forecast to double within a generation.