Evaluation of the efficacy of pimavanserin in the treatment of agitation and aggression in patients with Alzheimer's disease psychosis: a post hoc analysis

Abstract

Objectives Patients with Alzheimer's disease psychosis (ADP) commonly experience concomitant agitation and aggression. We investigated whether a reduction in ADP following pimavanserin treatment conferred a reduction in associated agitation and aggression.

Methods ACP‐103‐019 was a 12‐week, randomized, double‐blind, placebo‐controlled study that evaluated the efficacy of pimavanserin (34 mg) in reducing psychotic symptoms in patients with ADP. The primary endpoint was change from baseline in Neuropsychiatric Inventory‐Nursing Home Version‐Psychosis Score (NPI‐NH‐PS) at week six. A post hoc analysis examined whether there was a greater reduction in agitation and aggression (NPI‐NH domain C [agitation/aggression] and Cohen‐Mansfield Agitation Inventory‐Short Form [CMAI‐SF]) in pimavanserin‐treated patients who experienced a reduction of hallucinations and delusions (psychosis responders defined as ≥50% reduction from baseline in NPI‐NH‐PS, week six) when compared with those who did not (nonresponders).

Results Pimavanserin‐treated patients with ≥50% response in psychotic symptoms (n = 44) showed a greater improvement in agitation and aggression symptoms on the NPI‐NH domain C (week six, least squares mean [LSM] difference = −3.64, t = −4.69, P < .0001) and the CMAI‐SF (week six, LSM difference = −3.71, t = −2.01, P = .0483) than nonresponders (n = 32). Differences between psychosis responders and nonresponders were also observed in patients with more severe agitation and aggression at baseline on the NPI‐NH domain C (responders, n = 26; nonresponders, n = 13; week six, LSM difference = −3.03, t = −2.44, P = .019).

Conclusions Patients with ADP, who show improvement in psychotic symptoms after pimavanserin treatment, also experience an improvement in concomitant agitation and aggression.