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Cognitive Effects of Darifenacin and Oxybutynin Extended Release in Volunteers Aged 60 and Over

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

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
Last updated: January 18, 2008

Page last updated: August 23, 2015

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