Australia’s GKC (Global Kinetics Corp.) has enrolled the first of more than 400 Parkinson’s patients in its APPRISE clinical trial — a multicenter, randomized study that will determine whether the Personal KinetiGraph (PKG) system is appropriate for identifying which patients need to change the clinical management of their disease.
The trial, part of the Parkinson’s Outcomes Project, a project of the National Parkinson’s Foundation (NPF), will also evaluate whether this system can be used to improve patient outcomes.
Parkinson’s can be challenging for physicians to treat, because its symptoms vary greatly throughout the day — partly because of disease progression and drug-related factors. The PKG system involves the use of a watch that records an objective measurement of Parkinson’s symptoms. From that, it creates detailed reports about a patient’s symptoms in relation to external factors such as drug dosage and timing, sleep and exercise.
“Neurologists typically ask patients to keep a written diary to track fluctuations, but a device has the potential to be easier to use for the patient, easier to understand for the clinician and more accurate,” Peter Schmidt, the NPF’s senior vice president and chief mission officer, said in a press release. “The PKG automatically records patient symptoms with no intrusion on their daily activities, so our hope is that it will make a difference in routine care.”
This study is the first to assess the use of wearable sensors in the context of Parkinson’s disease symptom management. The goal of APPRISE is to determine the optimal dose and timing of Parkinson’s medication and determine the effect of drug changes on patient outcomes.
Launched in 2009, the Parkinson’s Outcomes Project is the largest-ever clinical study of Parkinson’s disease with nearly 10,000 patients in four countries. This ground-breaking initiative allows researchers to track and monitor the care over time of patients who are seen at NPF Centers of Excellence. It studies everyone with Parkinson’s — from newly diagnosed patients to people who have lived with Parkinson’s for 20 years or more, providing a comprehensive view of the disease and its overall impact on people’s lives.
“As a Parkinson’s Foundation Center of Excellence, we are excited to be part of the first US randomized study evaluating the use of the PKG in the Parkinson’s disease population,” said Dr. Rajesh Pahwa, principal investigator at Kansas University Medical Center, the site of the first enrolled patient. “In our clinic, using the PKG has helped us to better understand patients’ motor states during the day and allows us to better plan their treatment.”
The PKG is a patient-friendly, objective, algorithm-based technology that can lead to more personalized treatment and clinical management decisions, with the eventual goal of a higher quality of life for patients, Pahwa added.