Pimavanserin for the treatment of psychosis in Alzheimer’s disease: A literature review

Table 4 Summary Ballard et al[45], 2019

Ref.	Outcomes	Tolerability	Limitations
Ballard et al[45], 2019	For overall population: Adjusted mean change from baseline at week 6 (adjusted mean, MMRM analysis) for the NPI-NH psychosis score was -3.76 (0.65) for pimavanserin vs -1.93 (0.63) for placebo (delta = -1.84, 95% confidence interval (CI) [-3.64, -0.04], Cohen’s d = -0.32, P = 0.045); For patients with NPI-NH scores > 12: The mean change at week 6 was -10.15 (95%CI: -12.50, -7.80) for pimavanserin vs -5.72 (95%CI: -8.14, -3.30) for placebo (delta = -4.43 (95%CI: -7.81, -1.04), Cohen’s d effect size of -0.73, P = 0.011); In the more severe subgroup, pimavanserin was superior to placebo at week 6 in treating both hallucinations (P = 0.046) and delusions (P = 0.034); At week 6, 66.7% of those in the pimavanserin group improved to an NPI-NH psychosis score < 6 vs 32.0% of those in the placebo group (difference = 34.7%); At week 12, 45.5% of both pimavanserin and placebo-treated patients had an NPI-NH psychosis score < 6; The proportion with a baseline NPI-NH psychosis score ≥ 12 achieving a response was significantly (P < 0.05) greater with pimavanserin vs placebo	Incidence of aggression was 14.3% in the severe psychosis subgroup vs 10.0% in overall population; Incidence of agitation was 17.9% in severe subgroup and 21.1% in general population; Other side effects included falls, UTI, contusion, respiratory tract infections, anemia, edema, cellulitis, anxiety, increase in urea or potassium	Small sample size in subgroup; Subgroup analysis was secondary
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CI: Confidence interval; NPI–NH: Neuropsychiatric Inventory-Nursing Home version; UTI: Urinary tract infections.