By Marilynn Marchione | AP Dec. 4, 2019 at 7:48 p.m. CST
SAN DIEGO — A drug
that curbs delusions in Parkinson’s patients did the same for people with
Alzheimer’s disease and other forms of dementia in a study that was stopped
early because the benefit seemed clear.
If regulators agree,
the drug could become the first treatment specifically for dementia-related
psychosis and the first new medicine for Alzheimer’s in nearly two decades. It
targets some of the most troubling symptoms that patients and caregivers face —
hallucinations that often lead to anxiety, aggression, and physical and verbal
abuse.
Results were
disclosed Wednesday at a conference in San Diego.
“This would be a very
important advance,” said one independent expert, Dr. Howard Fillit, chief
science officer of the Alzheimer’s Drug Discovery Foundation.
Although 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, said Maria
Carrillo, the Alzheimer’s Association’s chief science officer.
The drug is
pimavanserin, a daily pill sold as Nuplazid by Acadia Pharmaceuticals Inc. It
was approved for Parkinson’s-related psychosis in 2016 and is thought to work
by blocking a brain chemical that seems to spur delusions.
About 8 million
Americans have dementia, and studies suggest that up to 30% of them develop
psychosis.
“It’s terrifying,”
said Dr. Jeffrey Cummings of the Cleveland Clinic Lou Ruvo Center for Brain
Health in Las Vegas. “You believe that people might be trying to hurt you. You
believe that people are stealing from you. You believe that your spouse is
unfaithful to you. Those are the three most common false beliefs.”
He consults for
Acadia and helped lead the study, which included about 400 people with dementia
and psychosis. All were given a low dose of the drug for three months, and
those who seemed to respond or benefit were then split into two groups. Half
continued on the drug and the others were given dummy pills for six months or
until they had a relapse or worsening of symptoms. Neither the patients nor
their doctors knew who was getting what.
Independent monitors
stopped the study when they saw that those on dummy pills were more than twice
as likely as those on the drug to relapse or worsen — 28% versus nearly 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 those on the drug. Two
deaths occurred, but study leaders said neither was related to the drug.
Carrillo said the
study was small, but the drug’s effect seemed large, and it’s not known whether
the federal Food and Drug Administration would want more evidence to approve a
new use.
Current
anti-psychotic medicines have some major drawbacks and are not approved for
dementia patients.
“They’re often used
off label because we have very few other options,” Fillit said.
All carry warnings
that they can raise the risk of death in elderly patients, as does Nuplazid.
Cost could be an
issue — about $3,000 a month. What patients pay can vary depending on insurance
coverage.
Marilynn Marchione
can be followed on Twitter at http://twitter.com/MMarchioneAP
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