Treat-to-Target trial aims to change the practice of care through advanced use of objective targets derived from an FDA-cleared PKG™ wearable technology
PORTSMOUTH, N.H. and MELBOURNE, Australia, April 11, 2018 (GLOBE NEWSWIRE) -- Global Kinetics Corporation Ltd., today announced it has received funding from The Michael J. Fox Foundation for Parkinson’s Research (MJFF), Shake It Up Australia Foundation, and Parkinson’s Victoria for a project aiming to spark a paradigm shift in the treatment and management of Parkinson’s disease (PD) utilising the company’s FDA-cleared and CE-marked Personal KinetiGraph™ (PKG™) wearable technology. The funding will support a global clinical trial, which will be the first randomised and controlled study to evaluate the widespread implementation of target ranges derived from a wearable device to dictate treatment decisions in PD.
The Michael J. Fox Foundation and Shake It Up Australia Foundation will collectively provide $250,000i to support the trial. Parkinson’s Victoria will provide $100,000 and will also contribute substantial support as the major delivery partner for the Treat-to-Target study.
Currently, there are no universal objective metrics and target ranges for assessing or managing PD that can be used in the same way that cholesterol or blood sugar levels, peak flow measures or blood pressure readings, for example, are used to manage other common chronic conditions. PD is the second most prevalent movement disorder worldwide.
John Schellhorn, CEO Global Kinetics Corporation, said, “To date, Global Kinetics has provided decision support information to clinicians across 17 countries with more than three million hours of clinical data from our PKG™ wearable device.”
“Our company operates within a dynamic ecosystem in which new wearable devices, apps and technologies for PD care are being developed every day. However, the defining feature of our technology is that it is already used every day to help people with Parkinson’s. Target ranges are the next evolution in the use of wearables to extend the benefits of measurement to people with Parkinson’s who have the greatest need for support,” Mr Schellhorn said.
Mark Frasier, Ph.D., Senior Vice President of Research Programs at MJFF, said, “The experience of Parkinson’s varies day to day, hour to hour. An objective tool, such as the wearable PKG™ technology, that passively collects data on the lived experience of Parkinson’s disease outside the clinic could give patients and their doctors greater insight to calibrate treatment plans and improve outcomes and to give scientists a metric with which to measure therapeutic impact and test potential therapies faster.”
Clyde Campbell, Founder and CEO of Shake It Up Australia Foundation, said, “Shake It Up Australia is excited to support the PKG™ technology in this trial which brings an opportunity to use objective measurement and targets to help Australians with Parkinson’s by gaining a real-life picture of current symptoms and responses to medications. PKG™ allows the Parkinson’s patient, their Neurologist & researchers access to vital information that can make a big difference to how we deal with Parkinson’s moving forward.”
Emma Collin, CEO Parkinson’s Victoria, said, “Parkinson’s Victoria is proud to fund this landmark research project providing those living in both metro and regional communities within Australia the opportunity to participate in an important clinical trial impacting the effectiveness of both current and future treatments of Parkinson’s. Over the coming months we will be reaching out to some 27,000 Victorians living with Parkinson’s to recruit participants in Victoria, a key implementation site for this phase of the study.”
The Treat-to-Target study has already commenced in a number of Australian clinical sites and will be running for 18 months. United States and European sites will be enrolled in coming months. Interim data are expected by December 2018, and guidelines on the use of objective measurement and targets underpinned by the PKG™ wearable technology based on the study’s findings will be released in early 2019 for mainstream clinical use.
About the Treat-to-Target Clinical Study
For most common chronic diseases, accurate and unbiased measurement of symptoms, such as blood glucose in diabetes or blood pressure in heart disease, is critical for calibrating treatment and management decisions. Alongside measurement, “normal” or “target” ranges help to guide decisions for doctors. For example, if blood sugar is high or low relative to a target range for diabetics, different drugs or actions are recommended. Objective targets are also important for accurately assessing potential new treatments as they provide a measureable goal for clinical trials.
For Parkinson’s disease, the idea of using objective and continuous measurements and targets to improve routine care is relatively new. This landmark “Treat-to-Target” study will use the Personal KinetiGraph™ ( PKG™) and objective target ranges in a formal controlled trial to establish whether it leads to improved outcomes for people with PD. The study will recruit 225 people with PD from numerous sites across Australia, Europe and the United States and evaluate the benefits and efficacy of using objective and continuous targets over a period of 18 months.
The benefits of objective treatment targets for clinical care in PD were highlighted in a recent publication in npj Parkinson’s Disease, which serves as the foundation for the clinical design of the landmark Treat-to-Target study (https://www.nature.com/articles/s41531-018-0046-4).
About Global Kinetics Corporation Ltd.
Global Kinetics Corporation Ltd. is committed to improving the lives of those with Parkinson’s disease with advanced medical technologies. The company was formed in 2007 to commercialise its lead product, the Personal KinetiGraph™ (PKG™), also known as the Parkinson’s KinetiGraph™ outside the USA. Developed in conjunction with the world-renowned Florey Institute of Neuroscience & Mental Health in Melbourne, Australia, the Personal KinetiGraph™ enables the precise monitoring, quantification and reporting of movement symptoms in Parkinson’s. Global Kinetics Corporation, a privately held company, is headquartered in Melbourne, Australia with offices in London UK, Minneapolis and Portsmouth, NH USA.
For more information, visit: www.globalkineticscorporation.com
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About The Michael J. Fox Foundation for Parkinson’s Research
As the world’s largest nonprofit funder of Parkinson’s research, The Michael J. Fox Foundation is dedicated to accelerating a cure for Parkinson’s disease and improved therapies for those living with the condition today. The Foundation pursues its goals through an aggressively funded, highly targeted research program coupled with active global engagement of scientists, Parkinson’s patients, business leaders, clinical trial participants, donors and volunteers. In addition to funding more than $800 million in research to date, the Foundation has fundamentally altered the trajectory of progress toward a cure. Operating at the hub of worldwide Parkinson’s research, the Foundation forges groundbreaking collaborations with industry leaders, academic scientists and government research funders; increases the flow of participants into Parkinson’s disease clinical trials with its online tool, Fox Trial Finder; promotes Parkinson’s awareness through high-profile advocacy, events and outreach; and coordinates the grassroots involvement of thousands of Team Fox members around the world. For more information, visit www.michaeljfox.org.
The Michael J Fox Foundation is providing support for this project in conjunction with Shake It Up Australia Foundation.
Shake It Up Australia Foundation is a not-for-profit organization established in 2011 to promote and fund Parkinson’s disease research in Australia. Shake It Up’s mission is clear; to improve treatments, stop the progression of and ultimately find a cure for Parkinson’s disease. The foundation was established by Clyde Campbell, a father of three and business owner who was diagnosed with Parkinson’s disease in 2009 at the age of 44. 100% of all donations to Shake It Up are invested in Australian based research, in partnership with the Michael J Fox Foundation. To date, Shake It Up has co-funded over $6 million to Parkinson’s projects. For more information, visit shakeitup.org.au/
About Parkinson’s Victoria
Parkinson’s Victoria raises awareness and funds for services and research to improve the quality of life for people with Parkinson’s across the state. Our Health Information Service provides expert information, peer support and education to people living with Parkinson’s, their families and healthcare professionals. We support world class research projects with funding, promotion to support participation and the translation of research results for the Parkinson’s community.
For more information about Parkinson’s Victoria and for information relating to recruitment for the Treat to Target trial, visit http://www.parkinsonsvic.org.au/
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