Simvastatin as a neuroprotective treatment for moderate PD (PD STAT)
Simvastatin as a neuroprotective treatment for Parkinson’s disease: a double-blind, randomised, placebo controlled futility study in patients of moderate severity.
Research Office, Level 2, MSCP
Duration of Study in the UK
3 years, 3 months, 0 days
Parkinson’s disease (PD) is a progressive, neurodegenerative condition affecting more than 127,000 people in the UK with a further 10,000 diagnosed each year. No drug has been shown to slow or reverse the neurodegenerative process of PD. All currently licensed therapies act as symptom-relieving agents, but have a limited lifespan of effectiveness because of neuronal loss.
Clinical trials of potential neuroprotective agents in PD are difficult to design due to the variability in disease characteristics and rate of progression. There is also no reliable biomarker for disease progression. There is some evidence to support a possible neuroprotective role for statins. This study has been designed to establish whether Simvastatin is of any value as a neuroprotective treatment in PD.
Eligible patients who consent to participate will be randomly allocated to receive either oral simvastatin capsules or a matched placebo over a two year period. This study is double blind so neither the participant or research team will know which study treatment the participant is allocated.
Over a 26 month period, participants will attend scheduled study clinic visits and complete a number of validated assessments. Participants will also be invited to complete questionnaires during this time. At the end of the study, the results of the assessments will be compared to determine the response of those receiving the oral simvastatin compared to those participants who received the matched placebo.
North East - Newcastle & North Tyneside 2 Research Ethics Committee
Date of REC Opinion
12 Oct 2015
Further Information Favourable Opinion