Efficacy was demonstrated in this patient population at the primary endpoint of 6 weeks, especially in those with more severe baseline NPI-NH-PS.
“If pimavanserin does turn out to be a more effective and safer alternative, that would be a great step forward in treating these distressing symptoms.”
Clive Ballard, MD, professor of age-related diseases and Dean of the University of Exeter Medical School, sat down with NeurologyLive at the 2018 Alzheimer’s Association International Conference to discuss pimavanserin in subjects with dementia-related psychosis.
At the meeting held in Chicago, Illinois, Ballard presented data on the phase II double-blind, placebo-controlled, trial, Study ACP-103-019, that was designed to evaluate the safety and efficacy of pimavanserin in those with Alzheimer disease psychosis—a more severe population.
On the primary endpoint, the mean change from baseline in the Neuropsychiatric Inventory-Nursing Home Version-Psychosis Score (NPI-NH-PS) at week 6, the study concluded that pimavanserin had a 3.76-point improvement in psychosis versus a 1.93-point improvement in placebo (delta = -1.84, Cohen’s d = -0.32, P = 0.0451). Following the 6-week efficacy evaluation, investigators continued pimavanserin therapy for another 6 weeks to test safety.
Treatment response ≥30% was observed in 55.2% vs. 37.4% (P = .0159) and for a ≥50% improvement 50.6% vs. 34.1% (P = .0240) for pimavanserin and placebo, respectively. In the post-hoc analysis of those with NPI-NH-PS≥12, a ≥30% improvement was observed in 88.9% vs. 43.3% (P = .0004) and for a ≥50% improvement 77.8% vs. 43.3% (P = .0084) for pimavanserin and placebo, respectively.
Compared with placebo, pimavanserin demonstrated significant benefit in subjects with Alzheimer disease psychosis at the primary endpoint and was found to have an acceptable tolerability profile, and no negative effect on cognition measured by the Mini-Mental State Examination (MMSE).
Pimavanserin has been granted breakthrough therapy designation by the FDA for dementia-related psychosis and researchers are currently conducting HARMONY, a phase III randomized, double-blind, placebo-controlled study, to evaluate the safety and efficacy of pimavanserin for treatment of hallucinations and delusions associated with dementia-related psychosis.