Simvastatin as a neuroprotective treatment for moderate Parkinson's disease

Not Applicable

Completed

• Conditions: Topic: Dementias and neurodegeneration; Subtopic: Parkinson’s Disease; Disease: Parkinson's disease; Nervous System Diseases; Parkinson's disease

• Registration Number: ISRCTN16108482
• Lead Sponsor: Plymouth Hospitals NHS Trust

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-11-19
• Study Completion: 2020-09-30
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 235

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient motor skills are determined using the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS Part III) in the OFF state at 12 and 24 months.