Cognitive Effects of Darifenacin and Oxybutynin Extended Release in Volunteers Aged 60 and Over
Information source: Novartis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy Volunteers
Intervention: Darifenacin (Drug); Oxybutynin (Drug); Placebo (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Novartis, Study Chair, Affiliation: East Hanover NJ
Summary
The purpose of this study is to explore the possible cognitive effects of darifenacin
modified release and long-acting oxybutynin.
Clinical Details
Official title: Cognitive Effects of Darifenacin and Oxybutynin Extended Release in Volunteers Aged 60 and Over
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Cognitive effect: measure of accuracy of delayed recall name-phase association test at week 3.
Secondary outcome: 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.
Eligibility
Minimum age: 60 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
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
Locations and Contacts
Washington Neuropsychological Institute LLC Georgetown, washington, District of Columbia 20016, United States
Additional Information
Starting date: February 2005
Ending date: May 2005
Last updated: January 18, 2008
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