| Title | Exploratory pilot study assessing the risk of cognitive impairment or sedation in the elderly following single doses of solifenacin 10 mg. | | Author(s) | Wesnes KA, Edgar C, Tretter RN, Bolodeoku J | | Institution | Cognitive Drug Research Ltd, CDR House, Gatehampton Road, Goring-on-Thames, RG8 0EN, UK +44 (0)1491 878700 ; +44 (0)1491 878701 ; keithw@cdr.eu.com. | | Source | Expert Opin Drug Saf 2009 Sep 11. | | Abstract | Objectives: To assess the cognitive effects of single doses of solifenacin 10 mg compared with placebo (primary objective) and oxybutynin immediate release (IR) 10 mg (secondary objective) in elderly subjects.
Methods: Single-centre, randomised, double-blind, placebo-controlled study in 12 healthy elderly volunteers, with three crossover periods separated by two 14-day washout periods. Each sequence consisted of a single dose of solifenacin 10 mg in one period, oxybutynin IR 10 mg in another and placebo in another. Aspects of attention, information processing, working memory, episodic memory and self-rated mood and alertness were tested using the validated Cognitive Drug Research computerised assessment system.
Results: There was no evidence from absolute mean values or changes from baseline to suggest that solifenacin 10 mg impaired cognition or self-ratings of mood and alertness versus placebo. Post-hoc ANCOVA showed no statistically significant cognitive deterioration with solifenacin versus placebo, when measured at a time point closest to the probable C(max) of solifenacin. Oxybutynin was associated with statistically significant impairments in several measures of cognitive function at a time point corresponding with its probable C(max).
Conclusion: In this pilot study, single 10 mg doses of solifenacin did not show any clear propensity to impair cognitive function in a healthy elderly population. | | Language | ENG | | Pub Type(s) | JOURNAL ARTICLE
| | PubMed ID | 19747069 |
|
