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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-000148-40 | EudraCT Number | ||
| 16108482 | Registry Identifier | ISRCTN |
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| Name | Class |
|---|---|
| University of Plymouth | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Simvastatin | Active Comparator | 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 |
|
| Matched Placebo | Placebo Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simvastatin | Drug |
| ||
| Matched Placebo (for Simvastatin) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Camille B Carroll, BM BCh, PhD | Clinical Lecturer (University of Plymouth) and Honorary Consultant Neurologist, Plymouth Hospitals NHS Trust. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal United Hospital | Bath | United Kingdom | ||||
| Royal Bournemouth Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31594876 | Derived | 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. |
| Label | URL |
|---|---|
| Trial website | View source |
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The data sharing plans for the current study are unknown and will be made available at a later date
On application
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|
| Timed motor tests - finger tapping and timed walk test (10MWT) in the OFF state, electromagnetic sensor (EMS) assessment in the OFF and ON state |
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. |
| at 12 and 24 months |
| Montgomery and Asberg Depression Rating Scale (MADRS) | The Montgomery and Asberg Depression Rating Scale (MADRS) is a 10 item physician rated depression severity scale previously used in the assessment of PD | at 12 and 24 months |
| The Addenbrooke's Cognitive Assessment-III (ACE-III) | 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 | at 12 and 24 months |
| Non-Motor Symptom assessment scale (NMSS) | The Non-Motor Symptom assessment scale (NMSS) is a rating scale designed to capture the presence of the non-motor features of PD | at 12 and 24 months |
| Parkinson's disease Questionnaire (PDQ-39) | 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. | at 12 and 24 months |
| Changes in PD medication as measured by levodopa-equivalent dose (LED) | at 12 and 24 months |
| Cholesterol levels (total, HDL, total/HDL ratio) | at 12 and 24 months |
| King's PD pain scale (KPPS) | 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. | at 12 and 24 months |
| EuroQoL 5D-5L health status questionnaire (EQ-5D-5L) | at 12 and 24 months |
| Safety and tolerability of trial medication by adverse events (AEs) review. | 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. | at 24 months |
| 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 |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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| ID | Term |
|---|---|
| D019821 | Simvastatin |
| ID | Term |
|---|---|
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
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