Official Title: “Cognitive Effects of Darifenacin and Oxybutynin Extended Release in Volunteers Aged 60 and Over”

The purpose of this study is to explore the possible cognitive effects of darifenacin modified release and long-acting oxybutynin.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Darifenacin
  • Darifenacin modified release 7,5 mg tablets once daily titrated to 15 mg once daily
• Drug: Oxybutynin
  • Oxybutynin extended release 10 mg tablet once daily titrated to 15 mg, then to 20 mg once daily
• Drug: Placebo
  • Placebo once daily tablet (sham titration)

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Darifenacin
• Active Comparator: 2
  • Oxybutynin
• Placebo Comparator: 3
  • Placebo

Primary Measures

• Cognitive effect: measure of accuracy of delayed recall name-phase association test at week 3.

Secondary Measures

• 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.

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 60 Years

Maximum Age for this Clinical Trial: N/A

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Novartis Study Chair East Hanover NJ  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00170768

Study ID Number: CDAR328A2403

ClinicalTrials.gov Identifier: NCT00170768

Health Authority: United States: Food and Drug Administration