A drug that reduces delusions in Parkinson's patients did the same for people with Alzheimer's disease and other forms of dementia in a clinical trial that was stopped earlier because the benefit seemed clear.
If regulators agree, the drug may become the first one offered specifically for the treatment of dementia-related psychosis. It would also be the first new drug for Alzheimer's disease in nearly two decades.
The daily pill targets some of the most worrying symptoms that patients and caregivers face – hallucinations that often lead to anxiety, aggression and physical and verbal abuse.
The results of the trials were released this week in a Alzheimer's Conference in San Diego.
"This would be a very important advance," said an independent expert, Dr. Howard Fillit, science director of the Alzheimer's Drug Discovery Foundation.
While the field is focused on finding a cure for dementia and preventing future cases, "there is a huge unmet need for better treatment" for those who have it now, he said. Maria Carrillo, Assn science director of Alzheimer's disease.
The drug, pimavanserin, is sold as Nuplazid by Acadia Pharmaceuticals Inc. It was approved for Parkinson's-related psychosis in 2016 and is believed to work by blocking a brain chemical that appears to cause illusions.
About 8 million Americans have dementia, and studies suggest that up to 30% of them develop psychosis.
"It's terrifying," he said. Dr. Jeffrey Cummings at the Cleveland Clinic Lou Ruvo Center for Brain Health in Las Vegas. “You believe people may be trying to hurt you. You believe that people are stealing from you. You believe your spouse is unfaithful to you. These are the three most common false beliefs. "
Cummings consults with Acadia and helped lead the study, which included about 400 people with dementia and psychosis. All received a low dose of the drug for three months, and those who seemed to respond or benefit were divided into two groups. Half continued with the drug and the others received fake pills for six months or until they relapsed or worsened their symptoms. Neither the patients nor the doctors knew who was receiving what.
Independent monitors discontinued the study when they saw that those taking dummy pills were twice as likely as those taking the drug to relapse or worsen – 28% versus almost 13%.
There were relatively few serious side effects – 5% in the drug group and 4% in the others. Headaches and urinary tract infections were more common among drug users. Two deaths occurred, but study leaders said neither was drug-related.
Carrillo said the study was small, but the effect of the drug seemed large. It is unclear whether the Federal Food and Drug Administration wants more evidence to approve a new use.
Current antipsychotic medications have some important disadvantages and are not approved for dementia patients.
"They are often used off-label because we have very few other options," said Fillit.
All carry warnings that they may increase the risk of death in elderly patients, as does Nuplazid.
The drug costs about $ 3,000 a month, so cost can be a problem. The amount paid by patients may vary depending on insurance coverage.