NCT02992132

Study to Examine the Safety and Efficacy of Pimavanserin for the Treatment of Agitation and Aggression in Alzheimer's Disease (SERENE)

A Double-Blind, Placebo-Controlled Study to Examine the Safety and Efficacy of Pimavanserin for the Treatment of Agitation and Aggression in Alzheimer's Disease

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 111 (actual)
• Sponsor: ACADIA Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy of pimavanserin compared with placebo in treatment of agitation and aggression after 12 weeks of treatment

Conditions

• Agitation and Aggression in Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	Pimavanserin 34 mg	Pimavanserin 34 mg, tablet, taken as two 17 mg tablets, once daily by mouth
DRUG	Pimavanserin 20 mg	Pimavanserin 20 mg, tablet, taken as two 10 mg tablets, once daily by mouth
OTHER	Placebo	Placebo, taken as two tablets, once daily by mouth

Timeline

• Start date: 2016-11-01
• Primary completion: 2018-01-25
• Completion: 2018-02-16
• First posted: 2016-12-14
• Last updated: 2019-03-28
• Results posted: 2019-03-28

Locations

56 sites across 5 countries: United States, Chile, France, Spain, United Kingdom