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Trial record 1 of 177 for:    pd stat
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Simvastatin as a Neuroprotective Treatment for Moderate Parkinson's Disease (PD STAT)

This study is currently recruiting participants.
See Contacts and Locations
Verified April 2017 by Plymouth Hospitals NHS Trust
Sponsor:
Collaborator:
University of Plymouth
Information provided by (Responsible Party):
Plymouth Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT02787590
First received: May 26, 2016
Last updated: April 12, 2017
Last verified: April 2017
  Purpose
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 Intervention Phase
Parkinson Disease Drug: Simvastatin Drug: Matched Placebo (for Simvastatin) Phase 2

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Plymouth Hospitals NHS Trust:

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 [ 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).

  • 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 ]

Estimated Enrollment: 198
Study Start Date: September 2015
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: August 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: Simvastatin
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
Drug: Matched Placebo (for Simvastatin)

  Eligibility

Ages Eligible for Study:   40 Years to 90 Years   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02787590

Contacts
Contact: Peninsula Clinical Trials Unit penctu@plymouth.ac.uk

Locations
United Kingdom
Royal United Hospital Recruiting
Bath, United Kingdom
Royal Bournemouth Hospital Recruiting
Bournemouth, United Kingdom
Fairfield General Hospital Recruiting
Bury, United Kingdom
Addenbrooke's Hospital Recruiting
Cambridge, United Kingdom
St Peter's Hospital Recruiting
Chertsey, United Kingdom
Royal Devon and Exeter Hospital Recruiting
Exeter, United Kingdom
Leeds General Infirmary Recruiting
Leeds, United Kingdom
Charing Cross Hospital Recruiting
London, United Kingdom
King's College Hospital Recruiting
London, United Kingdom
Royal Free Hospital Recruiting
London, United Kingdom
Luton and Dunstable Hospital Recruiting
Luton, United Kingdom
Clinical Ageing Research Unit Recruiting
Newcastle, United Kingdom
Norfolk and Norwich University Hospital Recruiting
Norwich, United Kingdom
John Radcliffe Hospital Recruiting
Oxford, United Kingdom
Derriford Hospital Recruiting
Plymouth, United Kingdom
Royal Preston Hospital Recruiting
Preston, United Kingdom
Queen's Hospital Recruiting
Romford, United Kingdom
Salford Royal Hospital Recruiting
Salford, United Kingdom
Royal Hallamshire Hospital Recruiting
Sheffield, United Kingdom
Musgrove Park Hospital Recruiting
Taunton, United Kingdom
Royal Cornwall Hospital Recruiting
Truro, United Kingdom
Worcestershire Royal Hospital Not yet recruiting
Worcester, United Kingdom
Yeovil District Hospital Recruiting
Yeovil, United Kingdom
Sponsors and Collaborators
Plymouth Hospitals 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.
  More Information

Additional Information:
Responsible Party: Plymouth Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT02787590     History of Changes
Other Study ID Numbers: PDSTAT2015
2015-000148-40 ( EudraCT Number )
16108482 ( Registry Identifier: ISRCTN )
Study First Received: May 26, 2016
Last Updated: April 12, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Plymouth Hospitals NHS Trust:
Neurology

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Simvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 19, 2017