Clinical collaboration for Parkinson's research
A collaboration between the Garvan Institute of Medical Research, Shake It Up Australia Foundation, the University of Sydney, the Cure Parkinson’s Trust (UK), Michael J Fox Foundation (USA) and Parkinson’s Australia is part of an Australian-led, international clinical trial to fast-track Parkinson's disease research.
With the combined depth of expertise across eight clinical trial sites around Australia including the Brain and Mind Centre's Parkinson's disease Research Clinic, the Australian Parkinson's Mission (APM) collaboration combines a revolutionary clinical trial design using repurposed drugs with genomics research to target disease-causing pathways.
Parkinson’s disease currently affects around 100,000 Australians, with an additional 14,000 being diagnosed with the disease each year. There is no known cure yet and currently, treatments address symptoms.
With the support of a $30 million Medical Research Future Fund federal government grant, the most significant investment in Australian Parkinson’s research to date, the Australian Parkinson’s Mission (APM) is a significant step towards developing disease-modifying treatments for Parkinson’s patients.
Over five years, the APM will combine clinical trials with genomics research, biomarker analysis and induced pluripotent stem cell testing, to test the effectiveness of repurposed drugs that have demonstrated potential for slowing or stopping Parkinson’s disease progression.
Bringing together global experts in the Parkinson’s arena
Professor Simon Lewis, Director of the ForeFront Parkinson's Disease Research Clinic at the Brain & Mind Centre is the Clinical Lead for the program, bringing critical expertise in clinical trial design to the balance of skills.
He says the clinical chemistry between the Brain and Mind Centre and the Garvan Institute makes for a perfect partnership.
“From the very beginning of these discussions, I was very keen on the novel concept of targeting different pathways in the same trial” said Professor Lewis.
“On the clinical side, we measure the traditional indicators of disease progression, whilst some of our leading scientists at the University of Sydney, Prof Glenda Halliday and Dr Nic Dzamko have developed blood tests evaluating target and disease engagement to look at those important pathways underpinning the disease. Finally, the genomics arm led by the Garvan allows us to progress the field of precision medicine by identifying key genetic signatures.”
The first clinical trial is being conducted across eight sites across Australia, integrating clinical, biomarker and genomic information to identify the patients who respond to treatments that target specific changes taking place in the brain.
“We’re hoping that the outcomes of our clinical trials will provide evidence to suggest that a targeted treatment for treating patients with particular genetic signatures is possible”, said Professor Lewis.
Repurposing drugs
The first clinical trial is a three-arm randomised rial of repurposed drugs that have been proposed by an international committee of leading Parkinson’s experts.
Participants will undergo genetic and biomarker analysis to classify variations specific to the disease and the particular response to treatment. Over 48 weeks, they will receive one of the three trial medications and continue on their usual Parkinson’s medication. At the end of the 48 week treatment period, the study medication will be stopped, and 12 weeks later they will be reassessed.
“The reason for that is that if just by chance any of those drugs happen to improve the symptoms of Parkinson's disease, but not modify the progression of it, you'd expect there to be a washout at the end of that last 12 weeks”, said Professor Lewis.
Despite the impact of COVID-19, recruitment has been going strong and recruitment for APM Clinical Trial Two is expected to commence while the first trial is still running. “In clinical trial two we will test different agents and target different pathways, in an effort to explore new ways beating the disease”, Lewis explains.
New hope for Parkinson’s patients
Developing better patient care and family support for people with Parkinson’s Disease and related conditions is the key mission of the Brain and Mind Centre’s ForeFront Parkinson’s Disease Research Clinic.
“We’re currently running a symptomatic trial for Parkinson’s patients who have depression and we’re also recruiting for patients with Parkinson’s Disease, Dementia and Dementia Lewy Bodies, for a trial to try and improve their concentration”, said Professor Lewis.
Also on the horizon is a trial that aims to treat Parkinson’s patients experiencing freezing of gait episodes – a particular research passion for Professor Lewis. His team is also working on another disease slowing trial for treating another rare movement disorder, known as Progressive Supranuclear Palsy.
With all clinical trials, there is a vital balance required for maximum results. Both the need for research funding, combined with the importance of patient involvement are the foundational building blocks for a successful outcome, working towards the successful development of patient care and treatment in the future.