NCT00160147终止3 期
A Randomized, Double-Blind, Placebo-controlled, Efficacy, Safety, and Tolerability Study of Bifeprunox in the Treatment of Elderly Subjects With Psychosis and Behavioral Disturbances Associated With Dementia of the Alzheimer's Type
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 60
- 试验地点
- 51
- 主要终点
- Brief Psychiatric Rating Scale (BPRS) Total Score
研究概览
简要总结
This is a 10-week study with bifeprunox and placebo in elderly subjects with psychosis and behavioral disturbances associated with dementia of the alzheimer's type.
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
- 65 Years 至 90 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of dementia of the Alzheimer's type
排除标准
- •History of seizure disorder
- •Clinically significant electrocardiogram (ECG)
- •Clinical or radiological evidence of stroke, vascular dementia or dementia due to substance abuse, or head trauma
研究组 & 干预措施
1
Experimental
干预措施: bifeprunox (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Brief Psychiatric Rating Scale (BPRS) Total Score
时间窗: 10 weeks
次要结局
- Adverse events(10 weeks)
研究者
研究点 (51)
Loading locations...
相似试验
已完成
2 期
Safety Study of ORG 34517 for Major Depression With Psychotic FeaturesPsychotic DisordersMajor Depressive DisorderNCT00226278Weill Medical College of Cornell University25
已完成
不适用
Comparison of 10% milk ready-to-use food to 25% milk ready-to-use food in the treatment of severely malnourished, Malawian childreChildhood severe acute malnutritionNutritional, Metabolic, EndocrineUnspecified severe protein-energy malnutritionISRCTN54186063niversity of Malawi College of Medicine (Malawi)1,874
撤回
2 期
Naltrexone in the Treatment of PyromaniaPyromaniaNCT00467454University of Minnesota
已完成
不适用
Roflumilast and cognition in memory-impaired elderlyMental and Behavioural DisordersDementiaISRCTN96013814Takeda Pharma A/S80
已完成
2 期
BOSSA Study: Bosentan for the treatment of Steroid-resistant Pulmonary SarcoidosisSarcoidosis with pulmonary involvementHaematological DisordersSarcoidosisISRCTN73579020niversity Hospital Basel (Switzerland)36