Simvastatin as a Neuroprotective Treatment for Moderate Parkinson's Disease
PD STAT
3 other identifiers
interventional
235
1 country
24
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 parkinson-disease
Started Mar 2016
Longer than P75 for phase_2 parkinson-disease
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 8, 2016
CompletedFirst Submitted
Initial submission to the registry
May 26, 2016
CompletedFirst Posted
Study publicly available on registry
June 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedOctober 18, 2021
October 1, 2021
3.7 years
May 26, 2016
October 8, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in MDS-UPDRS part III (OFF) score
The MDS-UPDRS is the standard validated tool for the assessment of patients with Parkinson's Disease. This scale includes subsections collecting data regarding the impact of PD on a patient's mood and mental state, (UPDRS part I), their activities of daily living (UPDRS part II) an examination of the motor features of PD (UPDRS part III), and complications arising from the use of dopamine replacement (part IV).
Baseline and 24 Months
Secondary Outcomes (13)
MDS-UPDRS total score in the practically defined ON state
at 12 and 24 months
MDS-UPDRS part II subscale score in the practically defined ON state
at 12 and 24 months
Timed motor tests - finger tapping and timed walk test (10MWT) in the OFF state, electromagnetic sensor (EMS) assessment in the OFF and ON state
at 12 and 24 months
Montgomery and Asberg Depression Rating Scale (MADRS)
at 12 and 24 months
The Addenbrooke's Cognitive Assessment-III (ACE-III)
at 12 and 24 months
- +8 more secondary outcomes
Study Arms (2)
Simvastatin
ACTIVE COMPARATORA 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
Matched Placebo
PLACEBO COMPARATORA 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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital Plymouth NHS Trustlead
- University of Plymouthcollaborator
Study Sites (24)
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
Related Publications (1)
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.
PMID: 31594876DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Camille B Carroll, BM BCh, PhD
Clinical Lecturer (University of Plymouth) and Honorary Consultant Neurologist, Plymouth Hospitals NHS Trust.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 26, 2016
First Posted
June 1, 2016
Study Start
March 8, 2016
Primary Completion
November 1, 2019
Study Completion
December 31, 2020
Last Updated
October 18, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- On application
The data sharing plans for the current study are unknown and will be made available at a later date