NCT03325556

Relapse Prevention Study of Pimavanserin in Dementia-related Psychosis

A Double-blind, Placebo-controlled, Relapse Prevention Study of Pimavanserin for the Treatment of Hallucinations and Delusions Associated With Dementia-related Psychosis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 392 (actual)
• Sponsor: ACADIA Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 50 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dementia-related Psychosis

Interventions

Type	Name	Description
DRUG	Placebo	Placebo, tablets, once daily by mouth
DRUG	Pimavanserin 34 mg	Pimavanserin 34 mg total daily dose, tablets, once daily by mouth
DRUG	Pimavanserin 20 mg	Pimavanserin 20 mg total daily dose, tablets, once daily by mouth

Timeline

• Start date: 2017-09-27
• Primary completion: 2019-07-31
• Completion: 2019-10-30
• First posted: 2017-10-30
• Last updated: 2021-06-21
• Results posted: 2021-06-21

Locations

83 sites across 13 countries: United States, Bulgaria, Chile, Czechia, France, Germany, Italy, Poland, Serbia, Slovakia, Spain, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study