At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 392 enrolled
Drug / intervention
Placebo +2 moredrug
Likely dose
Pimavanserin 34 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double-blind, Placebo-controlled, Relapse Prevention Study of Pimavanserin for the Treatment of Hallucinations and Delusions Associated With Dementia-related Psychosis
In Brief
A Phase 3 clinical trial evaluating Placebo, Pimavanserin 34 mg, and 1 other intervention for Dementia-related Psychosis. Completed, enrolled 392 participants across 83 sites in 13 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDementia-related Psychosis
CountriesBulgaria, Chile, Czechia, France, Germany, Italy, Poland, Serbia, Slovakia, Spain, Ukraine, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
Enrollment StartSep 2017
First PostedOct 2017
Primary CompletionJul 2019
Study CompletionOct 2019
TodayJul 2026
First PostedOct 30, 2017
Enrollment StartSep 27, 2017
Primary CompletionJul 31, 2019
Study CompletionOct 30, 2019
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 8.7 years ago
Interventions
Placebodrug
Placebo, tablets, once daily by mouth
Pimavanserin 34 mgdrug
Pimavanserin 34 mg total daily dose, tablets, once daily by mouth
Pimavanserin 20 mgdrug
Pimavanserin 20 mg total daily dose, tablets, once daily by mouth