NCT01163227已完成2 期
A Randomized, Double-blind, Placebo-controlled, Cross-over, Single-dose Study to Evaluate the Effects of AQW051 on Cognitive Function in Patients With Chronic Stable Schizophrenia Including a One Week Multiple-dose Extension to Assess the Persistence of Observed Effects and a Multiple-dose Cross Over Study in Non Smokers Only.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Effects of single oral doses of AQW051 versus placebo on cognitive function as measured by selected CogState tests
研究概览
简要总结
This PoC study is designed to assess the cognitive effects of doses of AQW051 in patients with chronic stable schizophrenia.
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
- 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.
- •Any clinically significant suicidal ideation (Type 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) in the last month) or previous history of suicide behavior Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (single and multiple doses) (Drug)
AQW051 Dose 1
Experimental
干预措施: AQW051 2 mg (single and multiple doses) (Drug)
AQW051 Dose 2
Experimental
干预措施: AQW051 15mg (single and multiple doses) (Drug)
AQW051 Dose 3
Experimental
干预措施: AQW051 100mg (single dose), and 50mg (multiple doses) (Drug)
结局指标
主要结局
Effects of single oral doses of AQW051 versus placebo on cognitive function as measured by selected CogState tests
时间窗: 132 days Part A, 121 days Part B (screening to study completion)
次要结局
- Effects of single oral doses of AQW051 versus placebo on cognitive function as measured by selected MATRICS Consensus Cognitive Battery (MCCB) tests(132 days Part A, 121 days Part B (screening to study completion))
- Effects of multiple oral doses of AQW051 versus placebo on cognitive function as measured by selected CogState tests and selected MCCB tests(132 days Part A, 121 days Part B (screening to study completion))
- Correlation of the cognitive domains measured by MCCB versus CogState(132 days Part A, 121 days Part B (screening to study completion))
- Pharmacokinetics, safety and tolerability of single and multiple doses of AQW051 as compared to placebo(132 days Part A, 121 days Part B (screening to study completion))
研究者
研究点 (2)
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