Simvastatin as a Neuroprotective Treatment for Moderate Parkinson's Disease (PD STAT)
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| ClinicalTrials.gov Identifier: NCT02787590 |
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Recruitment Status :
Completed
First Posted : June 1, 2016
Last Update Posted : October 18, 2021
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Sponsor:
University Hospital Plymouth NHS Trust
Collaborator:
University of Plymouth
Information provided by (Responsible Party):
University Hospital Plymouth NHS Trust
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Parkinson Disease | Drug: Simvastatin Drug: Matched Placebo (for Simvastatin) | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 235 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Simvastatin as a Neuroprotective Treatment for Parkinson's Disease: a Double-blind, Randomised, Placebo Controlled Futility Study in Patients of Moderate Severity. |
| Actual Study Start Date : | March 8, 2016 |
| Actual Primary Completion Date : | November 1, 2019 |
| Actual Study Completion Date : | December 31, 2020 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Parkinson disease
MedlinePlus related topics:
Parkinson's Disease
Drug Information available for:
Simvastatin
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: 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
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Drug: Simvastatin |
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Placebo Comparator: 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
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Drug: Matched Placebo (for Simvastatin) |
Primary Outcome Measures :
- Change in MDS-UPDRS part III (OFF) score [ Time Frame: Baseline and 24 Months ]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).
Secondary Outcome Measures :
- MDS-UPDRS total score in the practically defined ON state [ Time Frame: at 12 and 24 months ]
- MDS-UPDRS part II subscale score in the practically defined ON state [ Time Frame: 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 [ Time Frame: at 12 and 24 months ]Timed Motor Tests include evaluating the number of hand taps (key strokes) that an individual can perform within 30 seconds and a timed walk test (10MWT). Electromagnetic Sensor Measurements include wearing sensors on the index finger and thumb whilst performing 4 MDS-UPDRS items.
- Montgomery and Asberg Depression Rating Scale (MADRS) [ Time Frame: at 12 and 24 months ]The Montgomery and Asberg Depression Rating Scale (MADRS) is a 10 item physician rated depression severity scale previously used in the assessment of PD
- The Addenbrooke's Cognitive Assessment-III (ACE-III) [ Time Frame: at 12 and 24 months ]The Addenbrooke's Cognitive Examination-III (ACE) is one of the most popular and PD STAT protocol version 2.2, 03 March 2016 EudraCT 2015-000148-40 ISRCTN16108482. REC Ref:15/NE/0324 Page 39 of 43 commonly used cognitive tests used in dementia clinics and in the assessment of other neurological disorders. ACE-III includes five subdomains which provide a cognitive score out of a maximum of 100
- Non-Motor Symptom assessment scale (NMSS) [ Time Frame: at 12 and 24 months ]The Non-Motor Symptom assessment scale (NMSS) is a rating scale designed to capture the presence of the non-motor features of PD
- Parkinson's disease Questionnaire (PDQ-39) [ Time Frame: at 12 and 24 months ]The PDQ39 is a PD-specific health status questionnaire used both clinically and within research since its publication in 1995. It consists of 39 items covering eight discrete dimensions: mobility, emotional well-being, stigma, social support, cognition, communication and bodily discomfort. The scores from each dimension are computed into a scale ranging from 0 (best, i.e. no problem at all) to 100 (worst, i.e. maximum level of problem). In addition a summary score, the PDQ-39SI (summary index) can be calculated by averaging the scores of the eight dimensions.
- Changes in PD medication as measured by levodopa-equivalent dose (LED) [ Time Frame: at 12 and 24 months ]
- Cholesterol levels (total, HDL, total/HDL ratio) [ Time Frame: at 12 and 24 months ]
- King's PD pain scale (KPPS) [ Time Frame: at 12 and 24 months ]The King's PD Pain Scale is a PD-specific scale consisting of 14 items within seven domains. Each item is scored by severity (0-3) multiplied by frequency (0-4), resulting in an item sub-score of 0-12 and a total possible score of 0-168.
- EuroQoL 5D-5L health status questionnaire (EQ-5D-5L) [ Time Frame: at 12 and 24 months ]
- Safety and tolerability of trial medication by adverse events (AEs) review. [ Time Frame: at 12 and 24 months ]
- Incidence of diabetes mellitus, using a glycated haemoglobin (HbA1c) level of 6.5% (48mmol/mol) as diagnostic of diabetes mellitus. [ Time Frame: at 24 months ]
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| Ages Eligible for Study: | 40 Years to 90 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02787590
Locations
Show 24 study locations
Sponsors and Collaborators
University Hospital Plymouth NHS Trust
University of Plymouth
Investigators
| Study Director: | Camille B Carroll, BM BCh, PhD | Clinical Lecturer (University of Plymouth) and Honorary Consultant Neurologist, Plymouth Hospitals NHS Trust. |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University Hospital Plymouth NHS Trust |
| ClinicalTrials.gov Identifier: | NCT02787590 |
| Other Study ID Numbers: |
PDSTAT2015 2015-000148-40 ( EudraCT Number ) 16108482 ( Registry Identifier: ISRCTN ) |
| First Posted: | June 1, 2016 Key Record Dates |
| Last Update Posted: | October 18, 2021 |
| Last Verified: | October 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | The data sharing plans for the current study are unknown and will be made available at a later date |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) |
| Time Frame: | On application |
Keywords provided by University Hospital Plymouth NHS Trust:
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Neurology |
Additional relevant MeSH terms:
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Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Synucleinopathies Neurodegenerative Diseases |
Simvastatin Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors |