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New drug may provide relief from psychosis in dementia

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A new kind of antipsychotic currently being trialled has been found to provide short-term relief from the “terrifying and disturbing” symptoms experienced by patients with Alzheimer’s disease.

A study led by the University of Exeter found that the drug pimavanserin (Nuplazid) significantly improved psychosis symptoms, but without the side-effects of currently-used antipsychotics.

“Psychosis is a particularly terrifying symptom of Alzheimer’s disease”

Clive Ballard

The research, published in the journal Lancet Neurology, found an even greater benefit in those with the most severe psychotic symptoms, said the researchers behind it.

Their study was a double-blind, placebo-controlled exploratory trial comparing the efficacy and safety of pimavanserin with placebo in 181 care home patients with Alzheimer’s disease psychosis.

The mean change in the psychosis score at week six – the primary endpoint – was −3.76 points for pimavanserin and −1.93 points for placebo. However, by week 12, no significant advantage for pimavanserin versus placebo was observed for the overall study population.

The early promise suggested in the phase II trial means its safety and efficacy in reducing psychotic symptoms in dementia is now being assessed in a larger-scale phase III trial in the US to see if it can prevent relapse of psychotic symptoms in some of the most common forms of dementia.

“Pimavanserin showed efficacy in patients with Alzheimer’s disease psychosis at the primary endpoint, with an acceptable tolerability profile and without negative effect on cognition,” said the study authors.

“We urgently need to do better by them, and our encouraging results provides hope”

Clive Ballard

They noted that, currently, there was no approved safe and effective treatment for psychotic symptoms. They highlighted that widely-used antipsychotics led to sedation and falls, and could also double the speed at which brain function deteriorated.

The drugs also resulted in 1,660 unnecessary strokes and 1,800 unnecessary deaths in the UK every year. However, the researchers highlighted that pimavanserin worked differently to other antipsychotics, by blocking a very specific nerve receptor (THT2A) in the brain.

The latest results build on previous research that found pimavanserin was effective for people with dementia related to Parkinson’s disease, according to the researchers.

However, while pimavanserin has been approved for use by the US Food and Drug Administration, it has not yet been submitted for approval to the European Medicines Agency.

Previously, the charity the Alzheimer’s Society said it was “imperative” that the drug went through European approval processes for Parkinson’s Disease dementia.

Lead study author Clive Ballard, professor of age-related diseases at Exeter, said: “Psychosis is a particularly terrifying symptom of Alzheimer’s disease.

University of Exeter

New drug may provide relief from psychosis in dementia

Clive Ballard

“People may experience paranoia, or see, hear or smell things that are not there,” he said. “It’s distressing both for those experiencing the delusions and for their carers.

“It’s particularly encouraging that most benefit was seen in those with the most severe psychotic symptom, as this group is most likely to be prescribed antipsychotics,” noted Professor Ballard.

“We are talking about vulnerable elderly, frail people who are suffering terrifying symptoms, being sedated with current antipsychotics even though its well known that they cause terrible health issues and even death in people with dementia, and have very little benefit,” he said.

He added: “We urgently need to do better by them, and our encouraging results provides hope. We’re delighted that our results have led to a larger phase III clinical trial which is now ongoing.”

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