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

Summary

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

Timeline

Start

2016-11

Primary completion

2018-01-25

Completion

2018-02-16

Outcome

Missed primary endpoint

registry analysis (superiority test); Placebo vs Pimavanserin 20 mg; Difference in LSM 5.1 (95% CI -4.8 to 15.0) NCT02992132 ↗

registry analysis (superiority test); Placebo vs Pimavanserin 34 mg; Difference in LSM 1.0 (95% CI -8.5 to 10.5) NCT02992132 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pimavanserin	Small molecule	20 mg	Oral
Subject	Pimavanserin	Small molecule	34 mg	Oral

Indications

No indication recorded.