Linked Clinical Trial Program – Australia

In 2016 the Cure Parkinson’s Trust (UK) spearheaded a unique initiative called the Linked Clinical Trials program (LCT) in collaboration with the Michael J Fox Foundation, the Van Andel Research Institute (Michigan), the Shake it Up Foundation and the Garvan Institute. This committee is made up of the world’s leading science and clinical experts in Parkinson’s Disease and has worked to study the merits of more than 70 potential ‘disease-modifying’ treatments, each with different but compelling biochemical reasons for their potential to slow or stop long term decline in Parkinson’s.

The Linked Clinical Trials (LCT) initiative identifies potential new therapies for Parkinson’s disease from drugs approved to treat other conditions and that have demonstrated neuroprotective effects in preclinical experiments. By using drugs that already have passed rigorous safety and toxicology trials, LCT aims to significantly cut the amount of time it takes for a potential treatment to move from the laboratory to clinical trials and, ultimately, to the patient. 

A number of these repurposed agents have already been taken into clinical trials and the most exciting result to date was published in the Lancet in 2017. This small UK based study demonstrated the potential of an existing diabetes treatment to slow disease progression in Parkinson’s, which has prompted the development of a larger international trial.

Research Team

New South Wales Trial

Shake it Up has identified Professor Simon Lewis (Brain & Mind Centre, University of Sydney), Professor Dominic Rowe (Macquarie University) and Professor Glenda Halliday (Brain & Mind Centre, University of Sydney) to coordinate the NSW arm of this project. Professor’s Lewis and Rowe are clinicians who as practising Neurologists also have active research programs in Parkinson’s. Professor Halliday is a Neuroscientist whose research program has been focusing on the development of biomarkers to diagnose and monitor Parkinson’s. All of these clinicians and researchers have been previously funded for their Parkinson’s research by Shake It Up and The Michael J. Fox Foundation.

The protocol for this trial will be  for four drugs and one placebo in patients with more established Parkinson’s as well as validating disease biomarkers that could be used to evaluate the efficacy of future therapeutic treatments

Progress

The Shake it Up Foundation has commissioned a Strategic Development Review to provide due diligence for a study in which four potential treatments will be trialled in patients with mid stage Parkinson’s Disease. This approach would be an international first and importantly will set Australia on a path of conducting further studies, which we hope will bring new treatments to slow Parkinson’s into clinical practice.

Funding

Shake It Up is seeking funding to support this project. This is a collaborative project requiring multiple funding sources.

Queensland Trial

The protocol for this study is to trial two re-purposed drugs against two placebo groups. The overall approach of the intended trial is to rapidly screen existing drugs that are licensed and used already in clinical practice for other indications to determine whether they are worth transitioning to Phase III, multi-centre, randomised, placebo-controlled, double blind trials. If successful, such trials would facilitate a change in the indication of already licensed medications to allow their use as disease modifying treatments for Parkinson’s disease.

Associate Professor John O'Sullivan

This project is a collaboration between the University of Queensland, Shake It Up, Queensland Government, The Wesley Research Institute, Griffith University and The Cure Parkinson’s Trust.

For further information please contact Vicki Miller, Executive General Manager, Strategic Partnerships or call 1300 361 803

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Final protocols and recruitment criteria are currently being finalised.   If you are interested in taking part in the trial please subscribe to our email newsletter and we will keep you updated.

 

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