NEW YORK--(BUSINESS WIRE)--Koneksa, a healthcare technology company pioneering evidence-based digital biomarkers, announced today that the first patient was enrolled in the LEARNS study, an observational study to determine the measurement reliability and responsiveness over time of digital biomarkers, using mobile and wearable-based assessments to improve signal detection for potential disease modifying therapies in neurodegenerative conditions including Parkinson's disease.
The Koneksa-sponsored clinical validation study, “A Two Part, ObservationaL Basket Study to DetErmine UsAbility, Validity and BiomarkeR Discovery for Mobile EEG, Wearable and Device Collected Objective MeasuremeNt of Disturbed Sleep and Neurologic Disorders (LEARNS),” will enroll up to 70 participants with Parkinson’s disease for the disease progression portion of the study. The remote measurement of disease utilizing digital biomarkers provides an opportunity to capture disease change and impacts in the context of daily living and in a more convenient fashion.
The remote measurement of disease utilizing digital biomarkers provides an opportunity to capture disease change and impacts in the context of daily living and in a more convenient fashion. The study will enroll up to 70 participants with Parkinson’s disease for the disease progression portion of the study.
The LEARNS study represents an effort utilizing digital biomarkers to remotely measure disease progression, providing a patient-centered opportunity to capture disease changes and impacts in the context of daily living. Both the basket and disease progression components of the study are designed to collect data across multiple time points, increasing convenience, reducing burden on both patients and clinics, and increasing precision using repeated measures. By incorporating both basket and disease progression components, the study aims to minimize in-clinic burden while enabling participants to complete robust assessments remotely.
"We’re excited to announce the enrollment of the first patient in our LEARNS study, which represents a major step forward in leveraging wearable and mobile device technology to advance our understanding and management of neurologic disorders and disturbed sleep,” said John Wagner, M.D., Ph.D., Chief Medical Officer, Koneksa. “The data collected in the LEARNS study enables a more comprehensive picture of digital biomarkers in neurologic disorders, to inform future studies on the detection of prodromal disease, changes in disease state prior to clinical presentation, and progression of clinical symptoms.”
“The LEARNS study will use individual measures from Koneksa’s neuroscience toolkit, to capture both clinician ratings and patient reported experiences. The study aims to address critical gaps in current knowledge in neurological disorders by harnessing the power of mobile EEG, wearable devices, and other advanced technologies to objectively measure sleep disturbances in real-world settings,” said Elena Izmailova, Ph.D., Chief Scientific Officer, Koneksa.
Koneksa’s digitally-enabled data collection model evaluated in this study, will inform future interventional trials and care management strategies in neurodegenerative diseases.
“At Koneksa, we’re leading the transformation of clinical trials with the integration of digital measures. We’re pioneering this evolution and creating a collaborative ecosystem, where companies can share insights with each other,” said Dave Hurry, Chief Data Officer, Koneksa. “Together with our partners, we're reshaping the landscape of healthcare by cultivating a community dedicated to deploying digital measures in Parkinson’s clinical trials.”
Koneksa is helping to build a research community with our PD Digital Biomarker Advisory Board. This growing community provides clinical and scientific expertise, fostering digital measurement adoption.
For more information about the LEARNS study, visit clinicaltrials.gov (NCT06219629).
About Koneksa
Koneksa is a healthcare technology company pioneering evidence-based digital biomarkers to accelerate clinical research and guide decision-making in drug development and market strategy. Our evidence-based biomarker solutions enable efficient clinical trial designs to help innovative therapies reach patients faster. Koneksa aims to revolutionize treatment effect detection in clinical research and improve patient outcomes. Learn more at koneksahealth.com.
