Exploratory pilot study assessing the risk of cognitive impairment or sedation in the elderly following single doses of solifenacin 10 mg.
OBJECTIVE
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).


CONCLUSIONS
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.
Wesnes
Keith A
KA
Cognitive Drug Research Ltd, Goring-on-Thames, UK. keithw@cdr.eu.com
Edgar
Chris
C
Tretter
Reiner N
RN
Bolodeoku
John
J
D000368:Aged; D001288:Attention / Q000187:drug effects; D003071:Cognition / Q000187:drug effects; D003072:Cognition Disorders / Q000139:chemically induced* / Q000453:epidemiology / Q000523:psychology; D018592:Cross-Over Studies; D056344:Executive Function / Q000187:drug effects; D005260:Female; D006801:Humans; D006993:Hypnotics and Sedatives; D007858:Learning / Q000187:drug effects; D008297:Male; D008333:Mandelic Acids / Q000494:pharmacology; D008568:Memory / Q000187:drug effects; D008570:Memory, Short-Term / Q000187:drug effects; D018727:Muscarinic Antagonists / Q000008:administration & dosage / Q000009:adverse effects*; D009483:Neuropsychological Tests; D010276:Parasympatholytics / Q000494:pharmacology; D010865:Pilot Projects; D011812:Quinuclidines / Q000008:administration & dosage / Q000009:adverse effects*; D011930:Reaction Time / Q000187:drug effects; D012306:Risk; D018401:Sample Size; D000069464:Solifenacin Succinate; D044005:Tetrahydroisoquinolines / Q000008:administration & dosage / Q000009:adverse effects*
D006993:Hypnotics and Sedatives; D008333:Mandelic Acids; D018727:Muscarinic Antagonists; D010276:Parasympatholytics; D011812:Quinuclidines; D044005:Tetrahydroisoquinolines; C005419:oxybutynin; D000069464:Solifenacin Succinate