The “overmedication” of agitated dementia patients — with the use of powerful antipsychotic drugs — is an ongoing issue in U.S. health care.
Now, British researchers say they may have found a medicine that helps ease those symptoms, but in a much safer way.
The newer antipsychotic pimavanserin appears to ease psychosis symptoms in people with Alzheimer’s disease without the serious side effects caused by current antipsychotics, according to a study funded by the drug’s maker.
According to the researchers, psychosis affects up to half of the 45 million Alzheimer’s patients worldwide, and that percentage is even higher among patients with other types of dementia.
Currently, there is no approved safe and effective treatment for this common symptom. Standard antipsychotics are widely used, but they can also raise the risk of falls, stroke and even death, and have been linked to a doubling in the rate of brain function decline, according to the study authors.
One study released earlier this month found that, given these concerns, the percentage of long-term U.S. nursing home residents receiving antipsychotic drugs fell from about 24 percent in late 2011 to less than 16 percent in 2017. But advocates for patients say the rate should still be much lower.
“Psychosis is a particularly terrifying symptom of Alzheimer’s disease,” explained Clive Ballard, the lead author of the current study.
“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 [caregivers],” said Ballard, who is professor of age-related diseases at the University of Exeter in England.
The new phase 2 clinical trial included 180 Alzheimer’s patients with psychosis. Ninety of them took pimavanserin and 90 were given a placebo, over a three-month period. The study was funded by Acadia Pharmaceuticals, which markets pimavanserin under the brand name Nuplazid.
Reported Feb. 12 in Lancet Neurology, the study found that pimavanserin seems to alleviate psychotic symptoms without many of the side effects seen with standard antipsychotics.
“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,” Ballard said in a university news release. “We are talking about vulnerable elderly, frail people who are suffering terrifying symptoms, being sedated with current antipsychotics even though it’s well-known that they cause terrible health issues and even death in people with dementia, and have very little benefit,” he said.
A prior study found that pimavanserin was effective for people with dementia related to Parkinson’s disease, and it’s been approved by the U.S. Food and Drug Administration for this use.
As the researchers explained, the drug works differently from standard antipsychotics, because it blocks a specific nerve receptor (THT2A) in the brain.
One geriatrician who’s unconnected to the study said pimavanserin does show promise.
The new study “demonstrated that the medication was well-tolerated and did reduce hallucinations at week 6,” said Dr. Gisele Wolf-Klein. She directs geriatric education at Northwell Health in Great Neck, N.Y. Wolf-Klein noted that patients included those “with possible and probable Alzheimer’s disease and psychotic symptoms, including visual or auditory hallucinations, delusions or both.”
She said that the longer-term effectiveness of pimavanserin remains to be seen, but the drug may be useful for patients experiencing “short term delusions, as seen in acute delirium.
“This option is of particular interest since the safety profile of this drug shows no detrimental effect on cognitive and motor symptoms, contrary to atypical antipsychotics,” Wolf-Klein said.
Dr. Gayatri Devi is a neurologist at Lenox Hill Hospital in New York City who often works with Alzheimer’s patients. She stressed that any drug “that is effective for treating psychotic symptoms, which are often more disturbing to caregivers than memory impairment, is very important in allowing patients to function and live at home.”
Indeed, Devi added that “one of the most common reasons for institutionalization is psychotic symptoms, including delusions and hallucinations. Many currently available drugs have serious adverse effects and drugs with fewer side effects are desperately needed.”
According to Ballard’s team, the safety and effectiveness of pimavanserin in reducing psychotic symptoms in dementia is now being assessed in a larger clinical trial in the United States.