A 12 Week, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Effects of Once Daily Doses of AQW051 on Cognition, in Stable Schizophrenia Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 147
- 试验地点
- 1
- 主要终点
- Visual learning and memory at 4 weeks
研究概览
简要总结
This is a study in chronic stable Schizophrenia with the purpose to answer the question of whether agonism of the nicotinic alpha7 receptor is capable of enhancing cognition in a well defined chronic stable patient population treated with antipsychotics as standard of care, and thus to support the future development of AQW051 for the treatment of cognitive impairment associated with Schizophrenia (CIAS).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of schizophrenia
- •Symptomatically stable and currently treated with a stable regimen for at least 3 (three) months prior to dosing with one of the following second generation of antipsychotics: risperidone, paliperidone, quetiapine, ziprasidone, aripiprazole.
- •Specific cognitive impairment
- •Smokers and non-smokers
排除标准
- •Current treatment with an anticholinergic or other agent known to adversely interfere with the cholinergic system, and/ or treatment with cholinesterase inhibitor within the last three (3) months prior to dosing.
- •Current treatment with conventional antipsychotics (e.g fluphenazine, haloperidol) or clozapine.
- •History of neuroleptic malignant syndrome.
- •Diagnosis of substance abuse (other than nicotine) within the last month and alcohol or substance dependence (other than nicotine) within the last 6 months.
- •Score 4 or 5 on the Suicidal Ideation item or any "yes" on the Suicidal Behavior item of the CSSR-S that is related to suicidal behavior occurring during the last 2 years
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
AQW051 10 mg/day
Two 5mg AQW051 capsules will be taken orally daily by patients from Day 1 until Day 84.
干预措施: AQW051 (Drug)
Placebo to AQW051
Matching placebo administered orally.
干预措施: Placebo (Drug)
结局指标
主要结局
Visual learning and memory at 4 weeks
时间窗: 4 weeks
The primary objective is to evaluate the pro-cognitive effects of AQW051 in a chronic stable schizophrenic patient population at week 4 as measured by the absolute change from baseline in CPAL number of errors (CogState battery) at week 4.
次要结局
- Effect on cognitive function after 12 weeks of treatment - CogState test battery.(Baseline, 12 weeks)
- Effect on cognitive function after 12 weeks of treatment - MCCB(Baseline, 12 weeks)
- Number of patients with adverse events(12 weeks)