Relapse Prevention Study of Pimavanserin in Dementia-related Psychosis
Summary
The purpose of this study is to evaluate the efficacy of pimavanserin compared to placebo in preventing relapse of psychotic symptoms in subjects with dementia-related psychosis who responded to 12 weeks of open label pimavanserin treatment.
Timeline
- Start
- 2017-09-27
- Primary completion
- 2019-07-31
- Completion
- 2019-10-30
Outcome
Met primary endpoint
registry analysis (superiority test); Pimavanserin Double-Blind Period vs Placebo Double-Blind Period; p = 0.0023; Hazard Ratio (HR) 0.353 (95% CI 0.172 to 0.727) NCT03325556 ↗
paper A relapse occurred in 12 of 95 patients (13%) in the pimavanserin group and in 28 of 99 (28%) in the placebo group (hazard ratio, 0.35; 95% confidence interval, 0.17 to 0.73; P = 0.005). PMID 34289275 ↗
release “its Phase 3 HARMONY study, a double-blind, placebo-controlled relapse prevention trial evaluating pimavanserin for the treatment of dementia-related psychosis, met its primary endpoint” acadia.com ↗
release “Phase 3 HARMONY study, which met its primary endpoint” acadia.com ↗
release “The sNDA is supported by results from the pivotal Phase 3 HARMONY study, which met its primary endpoint” acadia.com ↗
Publications
- Torres-Yaghi Y, Chrones L, Abler V, Brunson G. Safety and efficacy of pimavanserin in patients with Lewy body dementia experiencing dementia-related psychosis in the HARMONY study. BMC Neurol. 2025 Nov 24;25(1):479. doi: 10.1186/s12883-025-04496-8.
- Cummings JL, Ismail Z, Dickerson BC, Ballard C, Grossberg G, McEvoy B, Foff E, Atri A. Development and assessment of a brief screening tool for psychosis in dementia. Alzheimers Dement (Amst). 2021 Dec 7;13(1):e12254. doi: 10.1002/dad2.12254. eCollection 2021.
- Tariot PN, Cummings JL, Soto-Martin ME, Ballard C, Erten-Lyons D, Sultzer DL, Devanand DP, Weintraub D, McEvoy B, Youakim JM, Stankovic S, Foff EP. Trial of Pimavanserin in Dementia-Related Psychosis. N Engl J Med. 2021 Jul 22;385(4):309-319. doi: 10.1056/NEJMoa2034634.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pimavanserin | Small molecule | 20 mg | — |
| Subject | Pimavanserin | Small molecule | 34 mg | — |