Simvastatin as a neuroprotective treatment for Parkinson's disease: a double-blind, randomised, placebo controlled futility study in patients of moderate severity. - Simvastatin as a neuroprotective treatment for moderate PD (PD STAT)

Plymouth Hospitals NHS Trust0 个研究点目标入组 198 人开始时间: 2015年9月16日最近更新: 2020年10月19日

适应症

试验速览

暂无简介。

•Diagnosis of idiopathic PD
•Modified Hoehn and Yahr stage = 3.0 in the ON medication state
•Age 40-90 years
•On dopaminergic treatment with wearing-off phenomenon
•Able to comply with study protocol and willing to attend necessary study visits
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 150
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 48

•Diagnosis or suspicion of other cause for parkinsonism
•Known abnormality on CT or MRI brain imaging considered to be causing symptoms or signs of neurological dysfunction, or considered likely to compromise compliance with study protocol
•Concurrent dementia defined by MoCA score <21
•Concurrent severe depression defined by MADRS score >31
•Prior intracerebral surgical intervention for PD including deep brain stimulation, lesional surgery, growth factor administration, gene therapy or cell transplantation
•Already actively participating in a research study that might conflict with this trial
•Prior or current use of statins as a lipid lowering therapy
•Intolerance to statins
•Untreated hypothyroidism
•End stage renal disease (creatinine clearance <30 mL/min) or history of severe cardiac disease (angina, myocardial infarction or cardiac surgery in preceding two years)
•eGFR <30 mL/min
•History of alcoholism or liver impairment
•Creatine kinase (CK) >1.1 x upper limit of normal (ULN)
•Aspartate transaminase (AST) or alanine transaminase (ALT) >1.1 x ULN
•Females who are pregnant or breast feeding or of child-bearing potential and unwilling to use appropriate contraception methods whilst on trial treatment
•Currently taking any medication contraindicated with simvastatin use
•Any requirement for statin use
•Regular participation in endurance or high-impact sports
•Unable to abstain from consumption of grapefruit-based products

发起方