Phase 3
Completed N=392
Relapse Prevention Study of Pimavanserin in Dementia-related Psychosis
Dementia-related Psychosis
Source: ClinicalTrials.gov NCT03325556 ↗
Enrolled (actual)
392
Serious AEs
4.8%
Results posted
Jun 2021
Primary outcomePrimary: Time From Randomization to Relapse in the Double-blind (DB) Period — NA; NA days — p=0.0023
◆ Published Evidence
Highly cited
137citations · ~27 / year
Trial of Pimavanserin in Dementia-Related Psychosis.
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.
Linked Publications (3)
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Trial of Pimavanserin in Dementia-Related Psychosis.
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Development and assessment of a brief screening tool for psychosis in dementia.
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Safety and efficacy of pimavanserin in patients with Lewy body dementia experiencing dementia-related psychosis in the HARMONY study.
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 |
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) and the linked publication. 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. Informational only — not medical advice.