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

Funding information ACADIA Pharmaceuticals Inc 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, placebocontrolled 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 pimavanserintreated 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.

Reduction and prevention of agitation in persons with neurocognitive disorders: an international psychogeriatric association consensus algorithm

“…Pimavanserin is approved for the treatment of psychosis in Parkinson’s disease and appears not to produce extrapyramidal effects (Cummings et al ., 2014). This agent reduced agitation in persons with AD and psychosis if the psychosis responded to treatment (Ballard et al ., 2020).…”

Retrospective analyses evaluating the mortality risk associated with pimavanserin or other atypical antipsychotics in patients with Parkinson disease psychosis

“…Our literature search identified 10 studies that met our inclusion criteria. Five studies included comparisons of pimavanserin with atypical antipsychotics [47] , [48] , [49] , [50] , [51] , two were comparisons between pimavanserin and a control group of untreated patients [53] , [54] , one was a comparison of pimavanserin users to pimavanserin nonusers [52] , and two were pimavanserin OLEs [57] , [63] . Overall, the two Medicare database studies were likely the most rigorous and comprehensive, and both demonstrated comparable or lower all-cause MRs among new users of pimavanserin versus other atypical antipsychotics [47] , [48] .…”

Mapping new pharmacological interventions for cognitive function in Alzheimer’s disease: a systematic review of randomized clinical trials

“…Nabilone may improve agitation; however, more studies are needed to confirm these results ( Herrmann et al, 2019 ). On the other hand, pimavanserin may improve both agitation and aggression in patients with AD ( Ballard et al, 2020 ).…”