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A drug approved for hallucinations and delusions associated with Parkinson's disease was shown to be effective in treating patients suffering from dementia-related psychosis (DRP), according to a study presented at the Clinical Trials on Alzheimer's Disease meeting Wednesday night in San Diego.
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If the drug is approved for DRP, it would be the first therapy approved by the FDA for dementia-related psychosis.
Pimavanserin — brand name Nuplazid — was shown in a clinical trial to reduce the risk of psychotic relapse in patients suffering from DRP by nearly threefold, according to the study presented by Acadia Pharmaceuticals, which makes Nuplazid. The study examined 392 patients with DRP.
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DRP is associated with neurological conditions including Alzheimer's and Parkinson's.
Acadia says it will seek approval for the drug to treat DRP in 2020.
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The FDA has granted Breakthrough Therapy designation for Nuplazid for DRP treatment. The designation, according to the FDA, "is a process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s)."
“The results presented today are an important advance for patients and caregivers who struggle with the burden of dementia-related psychosis where no FDA-approved treatment is currently available,” said Dr. Jeffrey Cummings, director emeritus of Cleveland Clinic Lou Ruvo Center for Brain Health in Las Vegas, according to a press release. “Reducing the risk of relapse of psychotic symptoms by this magnitude is an important and meaningful outcome as these are serious events which could lead to poor patient outcomes and a significant increase in caregiver burden and distress.”
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About 8 million patients in the U.S. are living with dementia, and studies suggest that about 30 percent of them have psychosis, according to Acadia. Psychosis commonly consists of delusions and hallucinations. According to the pharmaceutical company: "Serious consequences have been associated with severe or persistent psychosis in patients with dementia such as repeated hospital admissions, increased likelihood of nursing home placement, progression of dementia, and increased risk of morbidity and mortality."
According to the Alzheimer's Association, Alzheimer’s costs $341,000 on average for the health needs of someone from diagnosis to death. Families pay 70 percent of this out of pocket. The cost of care is projected to increase to $1.1 trillion by 2050. Patient numbers are expected to climb from 53 million in 2018 to 88 million in 2050.
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