Objectives: To assess the effect of imidafenacin on cognitive function, including the conversion rate of mild cognitive impairment (MCI) to dementia, in a period of one year.
Methods: Patients newly administered imidafenacin to treat overactive bladder (OAB), including those who had MCI or dementia, were surveyed across Japan (cognitive safety analysis set [CSAS]), on all of whom we performed the Mini-Mental State Examination (MMSE) at baseline, 24- and 48-weeks after treatment. From CSAS, we extracted well described cases of OAB change as well as drug-related adverse events of dry mouth etc.