*News Update*

The PD-Stat study has now concluded and has shown that simvastatin holds no promise as a protective therapy in Parkinson’s. The study’s conclusion was announced at 4pm on Friday 11 September 2020 at the Movement Disorder Society in a poster presentation. Further details can be found here.

We anticipate publication of the results early next year (2021) along with the results of several important sub-studies that formed part of the trial.

 Dr Richard Wyse, Director of Research & Development at The Cure Parkinson’s Trust, said:

‘Given the strength of pre-clinical evidence, and the progress with simvastatin already being made in MS, this is a disappointing result. However we do now have a definitive answer, and that enables us to move forward to test a number of other drugs of interest, many of which have been used to treat other diseases, and all of which we have determined have compelling evidence they each have the potential to modify Parkinson’s progression. 

This has been an important trial as we have not only tested a study medication and evaluated novel outcomes, but also we have used this as an opportunity to understand the impact of involvement in clinical trials on participants and their loved ones.  As a result of this trial we now have motivated an active network of researchers who are keen to participate in running future studies of drugs of interest, evaluated and prioritised through the International Linked Clinical Trials process.‘

Further information and an analysis of the evidence for simvastatin can be found in a paper written by Dr Carroll and Richard Wyse: click here to access. 

 Helen Matthews, Deputy CEO of The Cure Parkinson’s Trust said:

‘This trial reached its conclusion thanks to the dedicated participants and network of committed study centres across the country. A huge thank you must go to the participants who not only contributed to this trial but also to the numerous sub-studies that have been part of this wider project. The commitment of participants enables us to secure the definitive answers needed in Parkinson’s trials and we cannot undertake this research without them.’

For more information on the PD-Stat trial please visit www.cureparkinsons.org.uk/News/simvastatin-trial-update

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What is Simvastatin and why is this drug important in CPT's research programme?

Simvastatin is a drug currently used to treat people with high cholesterol. There is some evidence that these drugs - statins - have a potential neuro-protective role and this study has been designed to establish whether Simvastatin is of any value as a neuro-protective treatment in Parkinson’s*. The trial will investigate the value of Simvastatin as a treatment, not as a preventative measure in Parkinson’s.

Why do researchers think this drug is a prospective treatment to slow, stop or reverse Parkinson’s?

It is hoped that Simvastatin may protect neuronal function in the brain, reduce cell death and reduce and protect against oxidative stress of neurones in the brain. Oxidative stress is, in essence, an imbalance between the production of highly reactive chemical substances in cells and the ability of the body to neutralise or detoxify these harmful effects resulting in cell damage or death. As a potentially neuro-protective drug, Simvastatin may have the ability to slow or stop the progression of the disease.

NB: CPT is interested in investigating the use of Simvastatin as discussed in two important studies: Yan J et al -'Simvastatin prevents dopaminergic neurodegeneration in experimental parkinsonian models: the association with anti-inflammatory responses' PLoS One 2011 and Bar-On et al - 'Statins reduce neuronal alpha-synuclein aggregation in in-vitro models of Parkinson’s' J Neurochem 2008.

These studies highlight that Simvastatin works as an anti-inflammatory and reduces alpha-synuclein clumping, which is a signature of Parkinson’s progression. It is therefore critical to understand the effect Simvastatin has in people living with Parkinson’s, as the evidence from these two journals suggest that it could have a disease modifying effect.

Find out more about the Multi-Arm Multi-Stage trial programme in Parkinson's used in PD-STAT and other trials.

* Dr Richard Wyse (CPT's Director of Research) and Dr Camille Carroll who is leading the trial, make a compelling case for testing simvastatin as a potential disease modifying therapy in Parkinson’s in a recent article in the Journal of Parkinson’s Disease.

Further reading:

Simvastatin as a neuroprotective treatment for Parkinsons disease (PD STAT): protocol for a double-blind, randomised, placebo-controlled futility study - The BMJ Open

https://penctu.psmd.plymouth.ac.uk/pdstat/

'Drug Repurposing in Parkinson's' ~ Dr Dilan Athauda and Professor Tom Foltynie

'Harnessing the trophic and modulatory potential of statins in a dopaminergic cell line' - M Schmitt et al.