ISRCTN16108482已完成未知
Simvastatin as a neuroprotective treatment for Parkinson's disease: a double-blind, randomised, placebo-controlled futility study in patients of moderate severity
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 235
研究概览
简要总结
2019 Protocol article in https://pubmed.ncbi.nlm.nih.gov/31594876/ protocol (added 23/07/2020) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36315128/ (added 01/11/2022)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Diagnosis of idiopathic PD
- •2. Modified Hoehn and Yahr stage = 3.0 in the ON medication state
- •3. Age 40-90 years
- •4. On dopaminergic treatment with wearing-off phenomenon
- •5. Able to comply with study protocol and willing to attend necessary study visits
排除标准
- •1. Diagnosis or suspicion of other cause for parkinsonism
- •2. 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
- •3. Concurrent dementia defined by MoCA score <21
- •4. Concurrent severe depression defined by MADRS score >31
- •5. Prior intracerebral surgical intervention for PD including deep brain stimulation, lesional surgery, growth factor administration, gene therapy or cell transplantation
- •6. Already actively participating in a research study that might conflict with this trial
- •7. Prior or current use of statins as a lipid lowering therapy
- •8. Intolerance to statins
- •9. Untreated hypothyroidism
- •10. 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)
- •11. eGFR <30 mL/min
- •12. History of alcoholism or liver impairment
- •13. Creatine kinase (CK) >1.1 x upper limit of normal (ULN)
- •14. Aspartate transaminase (AST) or alanine transaminase (ALT) >1.1 x ULN
- •15. Females who are pregnant or breast feeding or of childbearing potential and unwilling to use appropriate contraception methods whilst on trial treatment
- •16. Currently taking any medication contraindicated with simvastatin use
- •17. Any requirement for statin use
- •18. Regular participation in endurance or high impact sports
- •19. Unable to abstain from consumption of grapefruit based products
研究者
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