The Effect of Anticholinergics on Cognitive Function in the Elderly

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effect of Anticholinergics on Cognitive Function in the Elderly: a Randomized Controlled Trial

Conditions
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Mental Competency, Urinary Bladder, Overactive, Cognitive Function

Intervention / Treatment
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* Drug: Trospium Chloride
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female 50 or older Diagnosis of OAB (ICS definition) English literacy Ability to swallow oral medication Cognitive ability to give consent Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TROSPIUM CHLORIDE<br>Those with overactive bladder will be administered either a placebo or Sanctura XR extended release (Trospium chloride) for treatment (60 mg). | Drug: Trospium Chloride<br>* Subject will be administered either placebo or 60 mg dosage of Sanctura XR for treatment of overactive bladder. Subject will take Sanctura XR once every morning. Blood will be drawn for plasma extraction at each visit.<br>* Other names: Sanctura XR;|
| Placebo Comparator: PLACEBO<br>Subjects may be administered a placebo rather than the Sanctura XR (Trospium Chloride). | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hopkins Verbal Learning Test - Revised | Assesses short term verbal learning and memory. Subscales include immediate recall (0-36) and delayed recall (0-12). Higher values indicate better outcomes. | Week 4 | 
| Hopkins Verbal Learning Test - Revised | 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. | Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mini-Mental State Examination | The mini-mental state examination (MMSE) or Folstein test is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. It is commonly used in medicine and allied health to screen for dementia. The range is 0-30, with higher values indicating better outcomes. | Week 4 | 
| Overactive Bladder Questionnaire | The Overactive Bladder Questionnaire (OAB-q) was developed to assess symptom bother and the impact of overactive bladder (OAB) on health-related quality of life (HRQL). The instrument was developed and validated in both continent and incontinent OAB patients, including both men and women. Total range is 19-101 and higher values indicate worse outcomes. | Week 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COGNITIVE FUNCTION, OVERACTIVE BLADDER, [C23.888.942.343.780]