Cognitive Effects of Darifenacin and Oxybutynin Extended Release in Volunteers Aged 60 and Over
Phase 2
Completed
- Conditions
- Healthy Volunteers
- Interventions
- Registration Number
- NCT00170768
- Lead Sponsor
- Novartis
- Brief Summary
The purpose of this study is to explore the possible cognitive effects of darifenacin modified release and long-acting oxybutynin.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
- Males and females aged 60 and over
- United States English as a primary language
- Given written informed consent by signing and dating an informed consent form prior to study entry
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Exclusion Criteria
- Current diseases in which the use of anti-cholinergic drugs is contraindicated, including the use of drugs with anti-cholinergic effects
- Volunteers with history of urinary retention or current bladder outlet obstruction, as determined by the investigator
Other protocol defined inclusion/exclusion criteria may apply.
- Current use of drugs known to effect memory and cognition Other protocol-defined inclusion/exclusion criteria may apply
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3 Placebo Placebo 1 Darifenacin Darifenacin 2 Oxybutynin Oxybutynin
- Primary Outcome Measures
Name Time Method Cognitive effect: measure of accuracy of delayed recall name-phase association test at week 3.
- Secondary Outcome Measures
Name Time Method Cognitive effect: measure of accuracy of delayed recall name-phase association test at week 1 & 2. Effects on other cognitive domains measured by various tests at week 1,2 and 3.
Trial Locations
- Locations (1)
Washington Neuropsychological Institute LLC Georgetown
🇺🇸Washington, District of Columbia, United States