Phase 3
N=392
Relapse Prevention Study of Pimavanserin in Dementia-related Psychosis
Dementia-related Psychosis
Bottom Line
View on ClinicalTrials.gov: NCT03325556 ↗Enrolled (actual)
392
Serious AEs
4.8%
Results posted
Jun 2021
Primary outcome: Primary: Time From Randomization to Relapse in the Double-blind (DB) Period — NA; NA days — p=0.0023
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Placebo (Drug); Pimavanserin 34 mg (Drug); Pimavanserin 20 mg (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- ACADIA Pharmaceuticals Inc.
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time From Randomization to Relapse in the Double-blind (DB) Period |
NA; NA | 0.0023 sig |
| SECONDARY Time From Randomization to Discontinuation From the DB Period for Any Reason |
NA; NA | 0.0024 sig |
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.
Eligibility Criteria
Inclusion Criteria
- Meets criteria for All-cause Dementia according to NIA-AA guidelines
- Meets clinical criteria for one of the following disorders: Dementia associated with Parkinson's disease, Dementia with Lewy bodies, Possible or probable Alzheimer's disease, Frontotemporal degeneration spectrum disorders, Vascular dementia
- Has an MMSE score ≥6 and ≤24
- Has had psychotic symptoms for at least 2 months
- Must be on a stable does of cholinesterase inhibitor or memantine, if applicable
- If the subject is female, she must not be pregnant or breastfeeding. She must also be of non-childbearing potential or must agree to use a clinically acceptable method of contraception for the duration of the study
Exclusion Criteria
- Has psychotic symptoms that are primarily attributable to a condition other than dementia
- Has had a recent major depressive episode
- Has experienced suicidal ideation or behavior within 3 months prior to study enrollment
- Has evidence of a non-neurologic medical comorbidity or medication use that could substantially impair cognition
- Has a history of ischemic stroke within the last 12 months or any evidence of hemorrhagic stroke
- Has a known history of cerebral amyloid angiopathy (CAA), epilepsy, CNS neoplasm, or unexplained syncope
- Has any of the following: greater than New York Heart Association (NYHA) Class 2 congestive heart failure, Grade 2 or greater angina pectoris, sustained ventricular tachycardia, ventricular fibrillation, torsade de pointes, syncope due to an arrhythmia, an implantable cardiac defibrillator
- Had a myocardial infarction within the last 6 months
- Has a known personal or family history or symptoms of long QT syndrome
- Has a significant unstable medical condition that could interfere with subject's ability to complete the study or comply with study procedures
- Requires treatment with a medication or other substance that is prohibited by the protocol
Additional inclusion/exclusion criteria apply. Subjects will be evaluated at screening to ensure that all criteria for study participation are met.
Data sourced from ClinicalTrials.gov (NCT03325556). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.