Healthy Volunteers
Conditions
Keywords
Darifenacin, oxybutynin, cognition, memory
Brief summary
The purpose of this study is to explore the possible cognitive effects of darifenacin modified release and long-acting oxybutynin.
Interventions
DRUGDarifenacin
Darifenacin modified release 7,5 mg tablets once daily titrated to 15 mg once daily
DRUGOxybutynin
Oxybutynin extended release 10 mg tablet once daily titrated to 15 mg, then to 20 mg once daily
DRUGPlacebo
Placebo once daily tablet (sham titration)
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cognitive effect: measure of accuracy of delayed recall name-phase association test at week 3. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
United States
Outcome results
None listed