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OpenTrials
Completed

NCT Number: NCT00170768

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.

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Key information

Conditions

Healthy Volunteers

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Washington Neuropsychological Institute LLC Georgetown

Washington D.C., District of Columbia, 20016, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Darifenacin

Drug

Darifenacin modified release 7,5 mg tablets once daily titrated to 15 mg once daily

Other names: Enablex

Oxybutynin

Drug

Oxybutynin extended release 10 mg tablet once daily titrated to 15 mg, then to 20 mg once daily

Placebo

Drug

Placebo once daily tablet (sham titration)

Primary outcomes

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

Secondary outcomes

  1. Cognitive effect: measure of accuracy of delayed recall name-phase association test at week 1 & 2.

  2. Effects on other cognitive domains measured by various tests at week 1,2 and 3.

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Important dates

Study start
2005
Study completion
2005
First posted
Sep 15, 2005
Registry last updated
Jan 23, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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