title: Randomised, multicentre, placebo-controlled, double-blind crossover study investigating the effect of solifenacin and oxybutynin in elderly people with mild cognitive impairment: the SENIOR study.
abstract: BACKGROUND
  Compared with younger people, the elderly are more likely to suffer from overactive bladder (OAB) and to have other chronic conditions that affect physical or cognitive function. Despite this, there are few data on the cognitive safety of antimuscarinic agents in older patients and none that examine the effect of these agents on those with mild cognitive impairment (MCI).
  
  
  OBJECTIVE
  To evaluate cognitive effects during chronic stable dosing with solifenacin and oxybutynin versus placebo in older (≥75 yr) subjects with MCI.
  
  
  METHODS
  A randomised, double-blind, triple-crossover trial in 26 elderly volunteers with MCI. Cognitive function was assessed using Cognitive Drug Research (CDR) computerised testing.
  
  
  METHODS
  Three treatment periods of 21 d each with solifenacin 5mg once daily, oxybutynin 5mg twice daily, or placebo, separated by 21-d washout periods.
  
  
  METHODS
  The primary end point was change from baseline in cognitive function with solifenacin at 6h postdose and oxybutynin at 2h postdose (time points close to their predicted time to peak concentration). Secondary end points included change in cognitive function at additional time points, and safety and tolerability assessments.
  
  
  CONCLUSIONS
  Neither agent was associated with significant changes from baseline in any of the five standard, composite outcomes of cognitive function (power of attention, continuity of attention, quality of working memory, quality of episodic memory, and speed of memory). In a secondary analysis, oxybutynin was associated with significant decreases in power and continuity of attention versus placebo at 1-2h postdose. Both agents were well tolerated, with the most frequently reported adverse event being mild or moderate dry mouth.
  
  
  CONCLUSIONS
  Solifenacin had no detectable effect on cognition in this group of elderly people with MCI.
authors: University of Alberta, Edmonton, Alberta, Canada. adrian.wagg@ualberta.ca
authors: Adrian
authors: A
authors: Wagg
authors: Mark
authors: M
authors: Dale
authors: Reiner
authors: R
authors: Tretter
authors: Bridget
authors: B
authors: Stow
authors: Gerhard
authors: G
authors: Compion
mesh_terms: D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000375:Aging / Q000523:psychology*; D000704:Analysis of Variance; D001288:Attention / Q000187:drug effects; D003071:Cognition / Q000187:drug effects*; D060825:Cognitive Dysfunction / Q000150:complications* / Q000175:diagnosis / Q000523:psychology; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D016018:Least-Squares Analysis; D008297:Male; D008333:Mandelic Acids / Q000009:adverse effects / Q000627:therapeutic use*; D008568:Memory / Q000187:drug effects; D018727:Muscarinic Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D011812:Quinuclidines / Q000009:adverse effects / Q000627:therapeutic use*; D012307:Risk Factors; D000069464:Solifenacin Succinate; D044005:Tetrahydroisoquinolines / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome; D006113:United Kingdom; D053201:Urinary Bladder, Overactive / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy*; D064804:Urological Agents / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D008333:Mandelic Acids; D018727:Muscarinic Antagonists; D011812:Quinuclidines; D044005:Tetrahydroisoquinolines; D064804:Urological Agents; C005419:oxybutynin; D000069464:Solifenacin Succinate