The Effect of Anticholinergics on Cognitive Function in the Elderly: a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Hopkins Verbal Learning Test - Revised
研究概览
简要总结
Anticholinergic medication is used to treat overactive bladder (OAB). A known side effect of this medication is cognitive dysfunction. OAB is more prevalent in the elderly population - a group that also has a higher baseline risk of cognitive dysfunction. Our objective is to evaluate the effect of an anticholinergic medication on cognitive function in elderly women.
详细描述
Subjects will be randomized to: 1) trospium chloride or 2) placebo.
There are three aims:
- To evaluate changes in cognitive function in elderly women taking trospium versus placebo, using validated cognitive assessment tests
- To develop a useful battery of cognitive screening tests for monitoring the cognitive safety of OAB management
- To understand how the timing of cognitive changes relates to the timing of improvement in OAB symptoms. The investigators will recruit 60 women aged ≥ 50 with the diagnosis of OAB. Cognitive assessments will be performed at baseline and Week 1 and 4 after drug initiation using paper-based validated questionnaires. OAB improvement will be assessed with validated questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female 50 or older
- •Diagnosis of OAB (ICS definition)
- •English literacy
- •Ability to swallow oral medication
- •Cognitive ability to give consent
排除标准
- •Dementia/Depression/Delirium
- •Current anticholinergic use (requires 2 week washout period)
- •Current cholinesterase
- •Urinary or gastric retention
- •Severe decreased gastrointestinal motility
- •Uncontrolled narrow-angle glaucoma
- •Myasthenia gravis
- •Diagnosis fo renal impairment (creatinine clearance <30 mL/min)
研究组 & 干预措施
PLACEBO
Subjects may be administered a placebo rather than the Sanctura XR (Trospium Chloride).
干预措施: Placebo (Drug)
TROSPIUM CHLORIDE
Those with overactive bladder will be administered either a placebo or Sanctura XR extended release (Trospium chloride) for treatment (60 mg).
干预措施: Trospium Chloride (Drug)
结局指标
主要结局
Hopkins Verbal Learning Test - Revised
时间窗: Week 4
Assesses short term verbal learning and memory. See below for the subscale delayed recognition (0-24). Percentages of total responses correct are reported for delayed recognition, higher values indicate better outcomes.
次要结局
- Mini-Mental State Examination(Week 4)
- Overactive Bladder Questionnaire(Week 4)