Table 2.
Completed or ongoing analyses from randomized, placebo-controlled studies with pimavanserin for neuropsychiatric disorders
Reference | Study Population | Treatments | Primary Endpoint | Primary Outcome |
---|---|---|---|---|
ACP-103-020 (29) | Parkinson’s disease psychosis | Pimavanserin 34 mg vs. placebo | SAPS-PD change from baseline to Week 6 | Significant improvement with pimavanserin vs. placebo |
ACP-103-020 (46) | Parkinson’s disease psychosis | Pimavanserin 34 mg vs. placebo | SAPS-PD at Week 6 stratified by baseline MMSE | Significant improvement in both groups, but more robust in cognitively impaired |
ACP-103-019 (30) | Alzheimer’s disease psychosis | Pimavanserin 34 mg vs. placebo | NPI-NH psychosis at Week 6 | Significant improvement for pimavanserin vs. placebo |
ACP-103-019 (47) | Alzheimer’s disease psychosis | Pimavanserin 34 mg vs. placebo | NPI-NH psychosis score at Week 6 by severity | Significant and more robust response in the severe subgroup |
NCT03325556 [ACP-103-045] | Dementia-related psychosis | Pimavanserin (20 mg and 34 mg flexible dosing) vs. placebo | Time from randomization to relapse; Time from randomization to all-cause discontinuation | Ongoing |