A 4 Way Placebo And Active Controlled Study To Evaluate The Effects Of Fesoterodine On Cognitive Function In Healthy Elderly Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Computer Based Objective Cognition Testing (CogState) Detection Speed
研究概览
简要总结
The study is designed to evaluate elements of cognitive function in subjects receiving either fesoterodine or alprazolam.
详细描述
Evaluation of cognitive function
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult healthy volunteers 65 years and over with minimum MMSE of 26
排除标准
- •Prohibited concomitant medications
- •Confounding medical conditions
- •Clinically significant comorbid diseases
- •Hypersensitivity or contraindications to fesoterodine or active control
研究组 & 干预措施
4mg fesoterodine
干预措施: 4mg fesoterodine (Drug)
fesoterodine 8mg
干预措施: 8mg fesoterodine (Drug)
1mg alprazolam
干预措施: alprazolam 1mg (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Computer Based Objective Cognition Testing (CogState) Detection Speed
时间窗: Baseline
Detection speed: a cognitive test which assessed psychomotor function. A playing card was presented face up in the center of the screen. As soon as this happened, the participant was to press the 'Yes' key. The outcome measure was speed of performance; mean of the log10 transformed reaction time for correct responses \[measured in log10 milliseconds (MS)\]. Lower scores meant a better performance.
Change From Baseline in Computer Based Objective Cognition Testing (CogState) Detection Speed on Day 6
时间窗: Baseline and Day 6
Detection speed: a cognitive test which assessed psychomotor function. A playing card was presented face up in the center of the screen. As soon as this happened, the participant was to press the 'Yes' key. The outcome measure was speed of performance; mean of the log10 transformed reaction time for correct responses \[measured in log10 milliseconds (MS)\]. Lower scores meant a better performance.
次要结局
- CogState Identification Speed(Baseline)
- Change From Baseline in CogState Identification Speed on Day 6(Baseline and Day 6)
- CogState One Card Learning(Baseline)
- Change From Baseline in CogState One Card Learning on Day 6(Baseline and Day 6)
- CogState Continuous Paired Associate Learning (CPAL)(Baseline)
- Change From Baseline in CogState CPAL on Day 6(Baseline and Day 6)
- CogState Groton Maze Learning Task (GMLT)(Baseline)
- Change From Baseline in CogState Groton Maze Learning Task on Day 6(Baseline and Day 6)
- Rey Auditory Verbal Learning Test (RAVLT)(Baseline)
- Rey Auditory Verbal Learning Test (RAVLT) on Day 6(Baseline and Day 6)