A Phase 2, Double-blind, Randomized, Placebo-controlled Cross-over Study of Nelotanserin Versus Placebo in Lewy Body Dementia (LBD) Subjects Experiencing Visual Hallucinations (VH)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 10
- 主要终点
- Safety will be evaluated based on incidence of adverse events (AEs) and significant changes in physical examinations, vital signs, ECGs, and routine clinical laboratory assessments from baseline to the end of each treatment period (28 days).
研究概览
简要总结
This study seeks to evaluate safety and efficacy of Nelotanserin for the treatment of visual hallucinations in subjects with Lewy body dementia.
详细描述
This is a double-blind, randomized, placebo-controlled, cross-over study in subjects with Lewy body dementia who experience frequent visual hallucinations.
Subjects who meet the randomization criteria enter the double-blind treatment period.
Each subject will be randomized 1:1 to one of the 2 treatment sequences: Nelotanserin in the first treatment period followed by placebo in the second treatment period, or placebo in the first treatment period followed by Nelotanserin in the second treatment period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult subjects at least 50 years of age, with a diagnosis of LBD based on DSM-5 diagnostic criteria or diagnosis of Parkinson's disease dementia (PDD) based on DSM-5 diagnostic criteria;
- •Presence of frequent visual hallucinations
- •Mini Mental State Examination score ≥ 18
排除标准
- •Subjects have a current diagnosis of significant psychotic disorders including, but not limited to, schizophrenia or bipolar disorder
- •Subjects' psychotic symptoms are secondary to or better accounted for by another medical condition, psychiatric disorder, or substance abuse
- •Subjects with a current serious and/or unstable cardiovascular, respiratory, thyroid, gastrointestinal, renal, hematologic or other medical disorder
研究组 & 干预措施
Nelotanserin
Nelotanserin 40mg then nelotanserin 80 mg
干预措施: Nelotanserin (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Safety will be evaluated based on incidence of adverse events (AEs) and significant changes in physical examinations, vital signs, ECGs, and routine clinical laboratory assessments from baseline to the end of each treatment period (28 days).
时间窗: 28 days
Extrapyramidal signs are assessed with the motor subsection of the Unified Parkinson's Disease Rating Scale (UPDRS, Parts II and III).
时间窗: 28 days
次要结局
- Change in the frequency and severity of visual hallucinations from baseline to the end of each treatment period (28 days) with Nelotanserin or placebo, as recorded and documented by the patient's caregiver(28 days)