Simvastatin as a neuroprotective treatment for Parkinson’s disease: a double-blind, randomised, placebo controlled futility study in patients of moderate severity

The study protocol includes an outline of the statistical methods to be employed in the analysis of the trial data. The purpose of the Statistical Analysis Plan (SAP) is to provide full details of the planned statistical methods to be used in the primary report of the trial results. The SAP has been drafted following published SAP Guidelines6, also taking cognisance of the CONSORT for parallel group trials7, the extension for reporting patient-reported outcomes8 and Harms9. However, it is worth noting that, as this is a futility trial, there will be some differences in the analysis of the outcome measures and presentation of the results compared to a typical definitive randomised trial. The electromagnetic sensor measurement and genetic sub-studies will be analysed separately by collaborators on the PD-STAT project. The statistical analyses outlined in this SAP do not pertain to data gathered from either of these sub-studies.The main objective of this trial was to determine the futility of Simvastatin in reducing neurodegenerative decline in patients with PD. The outcome measures will be recorded at baseline, 12, 24 and 26 months