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Pimavanserin reduces psychosis in Alzheimer’s disease
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Phase 2 findings indicated pimavanserin, a selective serotonin inverse agonist that targets 5-HT2A receptors, significantly reduced psychosis among patients with Alzheimer’s disease.
In October 2017, the FDA granted Breakthrough Therapy Designation to pimavanserin for treatment of psychosis related to dementia.
“In the phase II-019 study, pimavanserin significantly reduced psychosis in patients with Alzheimer’s disease without negatively impacting cognition,” Clive Ballard, MBChB, MRCPsych, of the University of Exeter Medical School, England, said in a press release. “Pimavanserin also had a favorable tolerability profile compared to known adverse effects of current antipsychotics. With no approved treatment for dementia-related psychosis, there is a significant unmet need. The results of the study indicate that pimavanserin could be an important new treatment option for this elderly and underserved patient population.”
To determine efficacy and safety of pimavanserin, researchers conducted a phase 2 double-blind, placebo-controlled study among 181 patients with Alzheimer’s disease psychosis.
At week 6 of dosing, study participants who received pimavanserin exhibited statistically significant reductions in psychosis, as measured by the Neuropsychiatric Inventory-Nursing Home (NPI-NH) psychosis score, compared with those who received placebo (55.2% vs. 37.4%).
When comparing participants who received pimavanserin or placebo, researchers did not find evidence of a negative effect on cognition.
Participants who received pimavanserin did not statistically differ from those who received placebo on secondary endpoints, including the Alzheimer’s Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC), Cohen-Mansfield Agitation Inventory Short Form (CMAI-SF), mean change in NPI-NH psychosis score at week 12 or the Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL).
Among participants with more severe psychosis who received pimavanserin, NPI-NH psychosis scores were significantly better at week 6, compared with placebo (88.9% vs. 43.3%).
Pimavanserin was well-tolerated, according to researchers.
Acadia is currently evaluating pimavanserin in a phase 3 study, HARMONY, to determine efficacy and safety for treatment of hallucinations and delusions associated with dementia-related psychosis.