Koneksa has announced the enrolment of the first patient in the LEARNS observational study aimed at evaluating the reliability and responsiveness of digital biomarkers in neurodegenerative disorders.

The study focuses on using mobile and wearable-based assessments to enhance signal detection for potential disease-modifying therapies, particularly in Parkinson’s disease.

Sponsored by Koneksa, it is titled “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”.

The clinical validation study is set to enrol up to 70 participants with Parkinson’s to monitor disease progression.

It utilises digital biomarkers to measure disease progression remotely, offering a patient-centred approach to track disease changes and impacts.

Koneksa chief scientific officer Elena Izmailova said: “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.”

The LEARNS study’s basket and disease progression components will involve collection of data across multiple time points, which is expected to reduce the burden on patients and clinics while enhancing the precision of measurements through repeated assessments.

Koneksa chief medical officer John Wagner said: “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.”

Koneksa's digitally enabled data collection model, evaluated in this study, is anticipated to shape future interventional trials and care management strategies for neurodegenerative diseases.

Last year, Koneksa partnered with Beacon Biosignals for a clinical trial to assess the integration of the latter’s at-home electroencephalogram (EEG) into its Neuroscience Solution Toolkit.