NCT02240459

A Study of Fesoterodine and Oxybutynin on Cognitive Function in Mild Cognitive Impairment

A Double Blind, Randomized Four Way Cross Over Study to Compare the Effect of Fesoterodine 4mg and 8mg Once Daily and Oxybutynin 5mg Twice Daily After Steady State Dosing Versus Placebo on Cognitive Function in Subjects With Overactive Bladder, Over the Age of 75 Years With Mild Cognitive Impairment

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: University of Alberta · Academic / Other
• Sex: All
• Age: 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Overactive Bladder
• Mild Cognitive Impairment

Interventions

Type	Name	Description
DRUG	fesoterodine 4mg	7 days therapy followed by seven days washout. Each 4mg tablet is taken in the morning
DRUG	Oxybutynin	5mg IR oxybutynin taken bid, encapsulated into a form indistinguishable from placebo
DRUG	placebo	placebo capsule, one twice daily, and 2 placebo fesoterodine tablets taken each morning for masking and comparator purposes
DRUG	fesoterodine 8mg	2, 4mg fesoterodine capsules taken together in the morning

Timeline

• Start date: 2016-08-01
• Primary completion: 2020-01-31
• Completion: 2020-01-31
• First posted: 2014-09-15
• Last updated: 2020-02-19

Locations

1 site across 1 country: Canada