A Double-blind, Placebo-controlled, Relapse Prevention Study of Pimavanserin for the Treatment of Hallucinations and Delusions Associated With Dementia-related Psychosis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 392
- 试验地点
- 83
- 主要终点
- Time From Randomization to Relapse in the Double-blind (DB) Period
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
Drug - Pimavanserin
干预措施: Pimavanserin 34 mg (Drug)
Drug - Pimavanserin
干预措施: Pimavanserin 20 mg (Drug)
结局指标
主要结局
Time From Randomization to Relapse in the Double-blind (DB) Period
时间窗: From randomization in the DB period through 26 weeks
The time from randomization to relapse in the DB period was compared between treatment groups using a Cox regression model. The treatment effect was measured by the hazard ratio (HR). Relapse was defined as (1) ≥30% increase in SAPS-H+D total score from DB baseline (BL) and CGI-I score ≥6 relative to DB BL, (2) treatment with antipsychotic for dementia-related delusions/hallucinations, (3) treatment/study discontinuation due to lack of efficacy, and/or (4) hospitalization for worsening dementia-related psychosis. SAPS-H+D is a 20-item scale; the total score is the sum of the 20 item scores (range 0-100); higher scores denote more severe symptoms. CGI-I is a clinician-rated 7-point scale to rate improvement in hallucinations/delusions relative to BL (range 1-7); higher scores denote less improvement or worsening. A pre-specified IA was conducted after accrual of 40 adjudicated relapse events. The prespecified stopping criterion was met; the study was stopped for efficacy.
次要结局
- Time From Randomization to Discontinuation From the DB Period for Any Reason(From randomization in the DB period through 26 weeks)