Simvastatin as a Neuroprotective Treatment for Moderate Parkinson's Disease

NCT ID: NCT02787590

Last Updated: 2021-10-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 235 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-08
• Study Completion Date: 2020-12-31

Brief Summary

Participants are randomly allocated to one of two treatment groups. In one group, participants are given capsules of simvastatin to take orally (by mouth) for 24 months. In the other group, participants are given placebo (dummy) capsules to take orally for 24 months. At the start of the study, when they receive their medication, participants complete a number of questionnaires and motor (movement) tests (a walking test and a finger tapping test). Participants in both groups also attend a further 6 clinic visits after 1, 6, 12, 18 and 24 and 26 months, where they are asked about their health and any medication they are taking, as well as repeating the questionnaires and motor tests. For 4 of the clinic visits, the participants will be asked to attend in the 'OFF medication' state (having omitted their usual PD medication) so that the researchers can get a true picture of their disease without it being masked by their normal medication.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Simvastatin

A one month low dose phase of 40mg oral simvastatin daily will be followed by a 23 month high dose phase of 80mg oral simvastatin daily and a final two month phase off trial medication

Group Type: ACTIVE_COMPARATOR

Simvastatin

Intervention Type: DRUG

Matched Placebo

A one month low dose phase of 40mg matched placebo daily will be followed by a 23 month high dose phase of 80mg matched placebo daily and a final two month phase off trial medication

Group Type: PLACEBO_COMPARATOR

Matched Placebo (for Simvastatin)

Intervention Type: DRUG

Interventions

Simvastatin

Intervention Type: DRUG

Matched Placebo (for Simvastatin)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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 (Appendix 2)
• Any requirement for statin use
• Regular participation in endurance or high-impact sports
• Unable to abstain from consumption of grapefruit-based products

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Plymouth

OTHER

Sponsor Role: collaborator

University Hospital Plymouth NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Camille B Carroll, BM BCh, PhD

Role: STUDY_DIRECTOR

Clinical Lecturer (University of Plymouth) and Honorary Consultant Neurologist, Plymouth Hospitals NHS Trust.

Locations

Royal United Hospital

Bath, , United Kingdom

Royal Bournemouth Hospital

Bournemouth, , United Kingdom

Fairfield General Hospital

Bury, , United Kingdom

Addenbrooke's Hospital

Cambridge, , United Kingdom

St Peter's Hospital

Chertsey, , United Kingdom

Royal Devon and Exeter Hospital

Exeter, , United Kingdom

Leeds General Infirmary

Leeds, , United Kingdom

Charing Cross Hospital

London, , United Kingdom

King's College Hospital

London, , United Kingdom

Royal Free Hospital

London, , United Kingdom

Luton and Dunstable Hospital

Luton, , United Kingdom

Clinical Ageing Research Unit

Newcastle, , United Kingdom

Norfolk and Norwich University Hospital

Norwich, , United Kingdom

John Radcliffe Hospital

Oxford, , United Kingdom

Derriford Hospital

Plymouth, , United Kingdom

Royal Preston Hospital

Preston, , United Kingdom

Queen's Hospital

Romford, , United Kingdom

Rotherham General Hospital

Rotherham, , United Kingdom

Salford Royal Hospital

Salford, , United Kingdom

Royal Hallamshire Hospital

Sheffield, , United Kingdom

Royal Stoke University Hospital

Stoke-on-Trent, , United Kingdom

Musgrove Park Hospital

Taunton, , United Kingdom

Royal Cornwall Hospital

Truro, , United Kingdom

Yeovil District Hospital

Yeovil, , United Kingdom

Countries

United Kingdom

References

Carroll CB, Webb D, Stevens KN, Vickery J, Eyre V, Ball S, Wyse R, Webber M, Foggo A, Zajicek J, Whone A, Creanor S. Simvastatin as a neuroprotective treatment for Parkinson's disease (PD STAT): protocol for a double-blind, randomised, placebo-controlled futility study. BMJ Open. 2019 Oct 7;9(10):e029740. doi: 10.1136/bmjopen-2019-029740.

Reference Type: DERIVED

PMID: 31594876 (View on PubMed)

Related Links

https://penctu.psmd.plymouth.ac.uk/pdstat/Default.aspx

Trial website

Other Identifiers

2015-000148-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

16108482

Identifier Type: REGISTRY

Identifier Source: secondary_id

PDSTAT2015

Identifier Type: -

Identifier Source: org_study_id