The purpose of this study is to assess the effects of fesoterodine at 4mg and 8mg doses versus a placebo and oxybutynin 5mg bid versus placebo on cognitive abilities in older people with overactive bladder and mild cognitive impairment.
This is a randomized placebo controlled, blinded four way cross over trial of the effect of medications used to treat overactive bladder on the cognition of older men and women with mild cognitive impairment. Each treatment phase is a week, with a weeks washout period before starting the next treatment. Cognitive testing is by way of a validated computer assisted battery of tests
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
47
7 days therapy followed by seven days washout. Each 4mg tablet is taken in the morning
5mg IR oxybutynin taken bid, encapsulated into a form indistinguishable from placebo
placebo capsule, one twice daily, and 2 placebo fesoterodine tablets taken each morning for masking and comparator purposes
Division of Geriatric Medicine, Clinical Sciences Building, University of Alberta Hosp
Edmonton, Alberta, Canada
continuity of attention
Continuity of Attention: Accuracy of responding in Choice Reaction Time task Percent Target Detection in Digit Vigilance task False Alarms in Digit Vigilance task
Time frame: 1 and 4h post dose
cognitive function
includes the following domains of cognition * power of attention, * quality of working memory, * quality of episodic secondary memory, * speed of memory * Montreal Cognitive assessment score
Time frame: 1 and 4h post last dose of study drug
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2, 4mg fesoterodine capsules taken together in the morning