NCT00863551已完成4 期
Sanctura Muscarinic Receptor Antagonist Resists Transport (SMART) Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 12
- 主要终点
- Cerebral Spinal Fluid Levels of Trospium at Day 10, Hour 5
研究概览
简要总结
This study evaluates the penetration through the blood-brain-barrier of trospium chloride at plasma steady state (Day 10) in elderly subjects with overactive bladder symptoms. Trospium levels in cerebrospinal fluid (CSF) and peak and trough plasma levels will be measured. Baseline and day 10 post-dose neurocognitive testing will be compared using a reliable change index to assess if any study subject shows evidence of a clinically and statistically significant change in memory.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 75 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 65-75 years of age without evidence of memory impairment
- •Subject has overactive bladder symptoms but otherwise healthy
- •Non-smoker (refrained from any tobacco usage, including smokeless tobacco, nicotine patches, etc., for 6 months prior to the screening visit)
- •Weight within normal range
- •Ability to follow study instructions and likely to complete all required visits
排除标准
- •Residual urine within bladder greater than 4 ounces
- •Moderate or severe memory impairment
- •Bleeding disorder
- •Blood-thinning agents
- •Concurrent overactive bladder medication
- •Concurrent dementia drugs: Aricept (donepezil), Namenda (memantine), Cognex (tacrine), Exelon (rivastigmine), Razadyne (galantamine), galantamine or similar drugs for dementia
- •Chronic kidney failure
- •Abdominal bypass surgery for obesity
研究组 & 干预措施
Trospium Chloride Extended Release, 60 mg
Experimental
Trospium Chloride Extended Release, 60 mg
干预措施: Trospium Chloride (Drug)
结局指标
主要结局
Cerebral Spinal Fluid Levels of Trospium at Day 10, Hour 5
时间窗: Day 10, Hour 5
Cerebral spinal fluid levels of Trospium at day 10, hour 5. Cerebral spinal fluid was collected from each patient.
次要结局
- Percentage of Study Subjects With No Clinically Significant Effect on Neurocognitive Function as Measured by the Brief Visuospatial Memory Test-Revised (BVMT-R) Total Score at Day 10 Post-Dose(Day 10)
- Percentage of Study Subjects With No Clinically Significant Effect on Neurocognitive Function Total Recall Score as Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R) at Day 10 Post-Dose(Day 10)
- Percentage of Study Subjects With No Clinically Significant Effect on Neurocognitive Function as Measured by the Brief Visuospatial Memory Test-Revised (BVMT-R) Delayed Recall Score at Day 10 Post-Dose(Day 10)
- Percentage of Study Subjects With No Clinically Significant Effect on Neurocognitive Function Delayed Recall Score as Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R) at Day 10 Post-Dose(Day 10)
研究者
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