Skip to content

Research at St Andrews

Simvastatin as a neuroprotective treatment for Parkinson's disease (PD STAT): protocol for a double-blind, randomised, placebo-controlled futility study

Research output: Contribution to journalArticle

Author(s)

Camille B. Carroll, Douglas Webb, Kara Nicola Stevens, Jane Vickery, Vicky Eyre, Susan Ball, Richard Wyse, Mike Webber, Andy Foggo, John Zajicek, Alan Whone, Siobhan Creanor

School/Research organisations

Abstract

INTRODUCTION: 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; ClinicalTrials.gov NCT02787590; Pre-results.

Close

Details

Original languageEnglish
Article numbere029740
Number of pages11
JournalBMJ Open
Volume9
Issue number10
DOIs
Publication statusPublished - 7 Oct 2019

    Research areas

  • MDS-UPDRS, Neuroprotective effect, Parkinson’s disease, Randomised controlled futility study, Statin

Discover related content
Find related publications, people, projects and more using interactive charts.

View graph of relations

Related by author

  1. Assessment of a home-based standing frame programme in people with progressive multiple sclerosis (SUMS): a pragmatic, multi-centre, randomised, controlled trial and cost-effectiveness analysis

    Freeman, J. A., Hendrie, W., Jarrett, L., Hawton, A., Barton, A., Dennett, R., Jones, B., Zajicek, J. P. & Creanor, S., 1 Aug 2019, In : Lancet Neurology. 18, 8, p. 736-747

    Research output: Contribution to journalArticle

  2. A self-management programme to reduce falls and improve safe mobility in people with secondary progressive MS: the BRiMS feasibility RCT

    Gunn, H., Andrade, J., Paul, L., Miller, L., Creanor, S., Stevens, K., Green, C., Ewings, P., Barton, A., Berrow, M., Vickery, J., Marshall, B., Zajicek, J. P. & Freeman, J., 1 Jun 2019, In : Health Technology Assessment. 23, 27, p. 1-166

    Research output: Contribution to journalArticle

  3. Machine-learning based identification of undiagnosed dementia in primary care: a feasibility study

    Jammeh, E. A., Carroll, C. B., Pearson, S. W., Escudero, J., Anastasiou, A., Zhao, P., Chenore, T., Zajicek, J. & Ifeachor, E., 12 Jun 2018, In : BJGP Open. 2, 2, 13 p., bjgpopen18X101589.

    Research output: Contribution to journalArticle

  4. Improving the quality of cognitive screening assessments: ACEmobile, an iPad-based version of the Addenbrooke's Cognitive Examination-III

    Newman, C. G. J., Bevins, A. D., Zajicek, J. P., Hodges, J. R., Vuillermoz, E., Dickenson, J. M., Kelly, D. S., Brown, S. & Noad, R. F., 2018, In : Alzheimer's & Dementia: Diagnosis, Assessment & Disease Monitoring. 10, p. 182-187 6 p.

    Research output: Contribution to journalArticle

  5. Balance Right in Multiple Sclerosis (BRiMS): a guided self-management programme to reduce falls and improve quality of life, balance and mobility in people with secondary progressive multiple sclerosis: a protocol for a feasibility randomised controlled trial

    Gunn, H., Andrade, J., Paul, L., Miller, L., Creanor, S., Green, C., Marsden, J., Ewings, P., Berrow, M., Vickery, J., Barton, A., Marshall, B., Zajicek, J. & Freeman, J. A., 27 Jul 2017, In : Pilot and Feasibility Studies. 4, 12 p., 26.

    Research output: Contribution to journalArticle

Related by journal

  1. Communication skills training for the radiotherapy team to manage cancer patients’ emotional concerns: a systematic review

    van Beusekom, M. M., Cameron, J., Bedi, C., Banks, E. & Humphris, G. M., 20 Apr 2019, In : BMJ Open. 9, 11 p., e025420.

    Research output: Contribution to journalReview article

  2. Participatory governance over research in an academic research network: the case of Diabetes Action Canada

    Willison, D. J., Trowbridge, J., Greiver, M., Keshavjee, K., Mumford, D. & Sullivan, F., Apr 2019, In : BMJ Open. 9, 4, 9 p., e026828.

    Research output: Contribution to journalArticle

  3. Protocol for the development of the STrengthening the Reporting of Pharmacogenetic Studies (STROPS) guideline: checklist of items for reporting pharmacogenetic studies

    Richardson, M., Kirkham, J. J., Dwan, K. M., Sloan, D. J., Davies, G. & Jorgensen, A., 11 Jul 2019, In : BMJ Open. 9, 7, 5 p., e030212.

    Research output: Contribution to journalArticle

  4. Trends in end digit preference for blood pressure and associations with cardiovascular outcomes in Canadian and UK primary care: a retrospective observational study

    Greiver, M., Kalia, S., Voruganti, T., Aliarzadeh, B., Moineddin, R., Hinton, W., Dawes, M., Sullivan, F., Syed, S., Williams, J. & De Lusignan, S., 24 Jan 2019, In : BMJ Open. 9, 1, 11 p., e024970.

    Research output: Contribution to journalArticle

ID: 262150862

Top