A new atypical antipsychotic, known as pimavanserin (Nuplazid), has been shown to help relieve the terrifying symptoms of psychosis in Alzheimer’s disease without the devastating side effects often seen with current antipsychotics, according to new findings published in the journal Lancet Neurology.
The study, conducted by researchers at the University of Exeter Medical School in the U.K., found that those with the most severe psychotic symptoms benefited most from the drug.
Up to half of the 45 million Alzheimer’s patients around the world will experience psychotic episodes, a figure that is even higher in some other forms of dementia. Psychosis is also associated with faster deterioration in dementia.
Currently, there is no medication proven to be safe and effective for these disturbing symptoms. In dementia patients, the use of antipsychotics often leads to sedation and can even double the speed at which brain function deteriorates. Their use also increases the risk of falls and leads to 1,660 unnecessary strokes and 1,800 unnecessary deaths in the U.K. every year. In addition, these drugs show very little benefit in improving psychosis in people with dementia.
Pimavanserin works differently than other antipsychotics, by blocking a very specific nerve receptor (THT2A) in the brain. In the new study, it was shown to effectively reduce symptoms of psychosis in Alzheimer’s patients without the damaging effects of other antipsychotics.
“Psychosis is a particularly terrifying symptom of Alzheimer’s disease. People may experience paranoia, or see, hear or smell things that are not there. It’s distressing both for those experiencing the delusions and for their carers,” said study leader Clive Ballard, professor of age-related diseases at the University of Exeter Medical School.
“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. 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.”
“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 three clinical trial which is now ongoing.”
The study was a double-blind, placebo-controlled exploratory trial designed to evaluate the effectiveness and safety of pimavanserin in 181 patients with Alzheimer’s disease psychosis. Half of the participants were given pimavanserin and half were put on placebo.
The hopeful findings build on previous research showing that pimavanserin is effective for people with dementia related to Parkinson’s disease. Pimavanserin has been approved for use by the Food and Drug Administration (FDA) in the U.S. for this purpose, but has not yet been submitted for approval to the European equivalent, the European Medicines Agency.
The safety and efficacy of the drug in reducing psychotic symptoms in dementia is now being assessed in a larger-scale clinical trial in the U.S.
Source: University of Exeter