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dc.contributor.authorCarroll, Camille B.
dc.contributor.authorWebb, Douglas
dc.contributor.authorStevens, Kara Nicola
dc.contributor.authorVickery, Jane
dc.contributor.authorEyre, Vicky
dc.contributor.authorBall, Susan
dc.contributor.authorWyse, Richard
dc.contributor.authorWebber, Mike
dc.contributor.authorFoggo, Andy
dc.contributor.authorZajicek, John
dc.contributor.authorWhone, Alan
dc.contributor.authorCreanor, Siobhan
dc.identifier.citationCarroll , C B , Webb , D , Stevens , K N , Vickery , J , Eyre , V , Ball , S , Wyse , R , Webber , M , Foggo , A , Zajicek , J , Whone , A & Creanor , S 2019 , ' Simvastatin as a neuroprotective treatment for Parkinson's disease (PD STAT) : protocol for a double-blind, randomised, placebo-controlled futility study ' , BMJ Open , vol. 9 , no. 10 , e029740 .
dc.identifier.otherORCID: /0000-0003-3481-825X/work/64034714
dc.descriptionThis work is supported by grants from The Cure Parkinson’s Trust and JP Moulton Charitable Foundation. SB is funded by the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care South West Peninsula (NIHR CLAHRC South West Peninsula).en
dc.description.abstractINTRODUCTION: Parkinson's disease (PD) is a progressive neurodegenerative condition affecting approximately 185,000 people in the UK. No drug has been proven to slow disease progression. Epidemiological and pre-clinical data support simvastatin, a widely used cholesterol-lowering drug with a well-established safety profile, having neuroprotective properties. The aim of this study (Simvastatin as a neuroprotective treatment for PD (PD STAT)) is to determine whether simvastatin has the potential to slow PD progression. The study is part of the International Linked Clinical Trials initiative coordinated by The Cure Parkinson's Trust. This paper describes the protocol for the PD STAT study. METHODS AND ANALYSIS: PD STAT is a double-blind, randomised, placebo-controlled, multi-centre, parallel group, futility trial in patients with PD of mild-moderate severity. 235 participants have been recruited and randomly allocated in a 1:1 ratio to receive either oral simvastatin or matched placebo. Treatment involves a 1-month low-dose phase (40 mg daily), followed by a 23-month high-dose phase (80 mg daily) and ends with a 2-month washout period. Participants are reviewed at clinic visits at 1 month, 6, 12, 18, 24 and 26 months post-baseline, with interim telephone follow-up to monitor for adverse events.The primary outcome is the change in the Movement Disorder Society Unified Parkinson's Disease Rating Scale part III motor subscale score in the practically defined OFF medication state (OFF state) between baseline and 24 months. Primary analysis will be on a modified intention to treat basis and will include only those participants who progress to the high-dose phase of the study. ETHICS AND DISSEMINATION: The protocol has been approved by the North East-Newcastle and North Tyneside 2 Research Ethics Committee. The results will be disseminated via research articles in peer-reviewed journals and presentations at local, national and international scientific meetings, as well as disseminated via patient groups, websites and networks. A summary of the study findings will be posted to participants at the end of the study. TRIAL REGISTRATION: ISRCTN16108482 (prospectively registered); EudraCT 2015-000148-40; NCT02787590; Pre-results.
dc.relation.ispartofBMJ Openen
dc.subjectNeuroprotective effecten
dc.subjectParkinson’s diseaseen
dc.subjectRandomised controlled futility studyen
dc.subjectRC0321 Neuroscience. Biological psychiatry. Neuropsychiatryen
dc.titleSimvastatin as a neuroprotective treatment for Parkinson's disease (PD STAT) : protocol for a double-blind, randomised, placebo-controlled futility studyen
dc.typeJournal articleen
dc.contributor.institutionUniversity of St Andrews. School of Medicineen
dc.contributor.institutionUniversity of St Andrews. Cellular Medicine Divisionen
dc.description.statusPeer revieweden

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