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

Novartis150 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

150

Conditions

Healthy Volunteers

Interventions

DarifenacinDRUG

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

OxybutyninDRUG

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

PlaceboDRUG

Placebo once daily tablet (sham titration)

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

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 (1)

Washington Neuropsychological Institute LLC Georgetown

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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