N-of-1 trials may provide insights into the impact of deprescribing medications in populations where evidence is currently lacking, such as the effect of statins on cognition in people with dementia. For this pilot, N-of-1, double-blinded, deprescribing trial, adults over 80 years of age with dementia taking statins for at least 6-months were recruited from a hospital's geriatric medicine outpatient clinic in Sydney, Australia. Participants discontinued and restarted statins over the study period. At enrolment, the hospital pharmacy-using a random number generator, randomised recruited participants to their usual statin or placebo regimen, with assessment and switching of treatment every 5 weeks from baseline (0-weeks) until Visit 4 (15-weeks). Primary outcome was measured using the rate of change in Alzheimer's Disease Assessment Score-Cognitive Subscale (ADAS-CoG). Over 6-months, 81 participants were screened, 14 were eligible, and four were randomised. One participant (female, 88 years) completed all four assessments with no major harms reported. Cognitive impairment, as measured by ADAS-CoG score, was similar on placebo (15.5/70) compared to statin (15/70). This study suggests there are significant challenges in performing N-of-1 trials and recruiting people with dementia into deprescribing trials from outpatient settings.Healthcare 2019, 7, 161 2 of 9 provide information in patient populations where the effects of medications on particular disease states is poorly understood [8]. For example, N-of-1 trials have been previously used to determine the optimum treatment for people with chronic diseases, such as schizophrenia, and can overcome the heterogeneity of treatment effects in these populations [9][10][11]. Inclusion of people with chronic diseases, who are generally excluded in clinical trials, appears to be safe, indicating the potential of recruitment involving older adults with cognitive impairment in N-of-1 trials [10,11]. N-of-1 trials have also been used in studying the side effects of statins, specifically, statin-related myalgia in older adults 65-years-old and above, indicating their potential for investigating the relationship between statins and other non-specific outcomes such as cognitive impairment [12]. Furthermore, deprescribing N-of-1 trials are safe and can generate strong patient-specific evidence on the benefits and harms of discontinuing medications, potentially informing and facilitating the conduct of subsequent, robust, clinical deprescribing trials [13].The aim of this pilot study was to examine the feasibility of conducting an N-of-1, deprescribing, trial in older adults with dementia, and to generate pilot data on the short-term impact of deprescribing statins on cognition in older adults with dementia.