Pimavanserin Confers Greater Improvements in Alzheimer Disease Psychosis vs Placebo
Pimavanserin is currently approved in the United States for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis.
|The following article is part of conference coverage from the 2018 Alzheimer's Association International Conference in Chicago, Illinois. Neurology Advisor's staff will be reporting breaking news associated with research conducted by leading experts in neurology. Check back for the latest news from AAIC 2018.|
CHICAGO – Compared with placebo, treatment with pimavanserin is associated with greater improvements in psychosis among patients with Alzheimer disease (AD), according to study findings presented by Clive Ballard, MD, of the University of Exeter Medical School in the United Kingdom, at the 2018 Alzheimer's Association International Conference, held July 22-26, 2018 in Chicago, Illinois.
“Safe and effective treatments for Alzheimer's disease psychosis (ADP) are an urgent priority,” the researchers wrote. Pimavanserin is currently approved in the United States for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis.
In the phase 2, double-blind, ACP-103-019 trial, the investigators assessed the safety and efficacy profile of pimavanserin in patients with ADP. Participants were randomly assigned to receive either pimavanserin (n=90) or placebo (n=91). Treatment response was defined as either a ≥30% or ≥50% improvement in ADP.
Mean baseline change in the Neuropsychiatric Inventory-Nursing Home Version-Psychosis Score (NPI-NH-PS) to 6 weeks comprised the primary endpoint. Following the 6-week efficacy evaluation, the investigators continued pimavanserin therapy through 12 weeks to test safety. Responder analyses and patient subgroups with a NPI-NH-PS of <12 or ≥12 were used for prespecified analyses of the primary outcome.
The investigators observed a significantly greater improvement in psychosis at 6-week follow-up in patients receiving pimavanserin vs placebo (3.76 points vs 1.93 points, respectively; delta=-1.84, Cohen's d=-0.32, P =.0451). Patients with a NPI‑NH-PS of ≥12 at baseline also experienced significantly larger effects of pimavanserin treatment vs patients with a baseline NPI‑NH-PS of <12 (delta=-4.43, Cohen's d=-0.734, P =.0114).
Treatment response ≥30% was greater among patients receiving pimavanserin (55.2% vs 37.4%; P =.0159). Pimavanserin was also associated with a greater improvement in symptoms by ≥50% compared with placebo (50.6% vs 34.1%, respectively; P =.0240). Additionally, pimavanserin was superior to placebo among patients with a NPI-NH-PS of ≥12 in providing a ≥30% improvement (88.9% vs 43.3%, respectively; P =.0004) and ≥50% improvement (77.8% vs 43.3%, respectively; P =.0084) in symptoms.
No differences were found between the 2 groups in regard to adverse events (AEs). Urinary tract infection, falls, and agitation were the most frequently reported AEs during the study. A greater proportion of patients reporting serious AEs were in the pimavanserin (16.7%) vs placebo (11.0%) group; however, fewer AE-related discontinuations were noted in the pimavanserin (8.9%) vs placebo group (12.1%). Mortality occurred in 4 patients from each arm. The investigators also found no impact of pimavanserin on Mini-Mental State Examination (MMSE) cognition.
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Ballard C, Youakim J, Coate B, Stankovic S. Pimavanserin in Alzheimer's disease psychosis: subgroup analysis of the more severe population. Presented at: 2018 Alzheimer's Association International Conference. July 22-26, 2018; Chicago, IL. Abstract 24754.