A Study of the Safety and Efficacy of Pimavanserin in Patients With Alzheimer's Disease Psychosis
Summary
This study will evaluate the safety and efficacy of pimavanserin 40 mg compared to placebo in patients with Alzheimer's disease psychosis.
Timeline
- Start
- 2013-11
- Primary completion
- 2016-09-28
- Completion
- 2016-10-27
Outcome
Met primary endpoint
registry analysis (superiority test); Placebo vs Pimavanserin 40 mg; p = 0.0451; Diff in MMRM LSM -1.84 (95% CI -3.64 to -0.04) NCT02035553 ↗
release “Pimavanserin demonstrated efficacy on the primary endpoint of the -019 Study” acadia.com ↗
release “Study of pimavanserin in Alzheimer’s disease psychosis, pimavanserin demonstrated clinically meaningful and statistically significant efficacy of pimavanserin 34 mg over placebo on the primary endpoint” acadia.com ↗
release “Pimavanserin met the primary endpoint in the Phase II -019 Study” acadia.com ↗
Publications
- Muhlbauer V, Mohler R, Dichter MN, Zuidema SU, Kopke S, Luijendijk HJ. Antipsychotics for agitation and psychosis in people with Alzheimer's disease and vascular dementia. Cochrane Database Syst Rev. 2021 Dec 17;12(12):CD013304. doi: 10.1002/14651858.CD013304.pub2.
- Ballard C, Banister C, Khan Z, Cummings J, Demos G, Coate B, Youakim JM, Owen R, Stankovic S; ADP Investigators. Evaluation of the safety, tolerability, and efficacy of pimavanserin versus placebo in patients with Alzheimer's disease psychosis: a phase 2, randomised, placebo-controlled, double-blind study. Lancet Neurol. 2018 Mar;17(3):213-222. doi: 10.1016/S1474-4422(18)30039-5.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pimavanserin | Small molecule | 40 mg | Oral |