Pharma Focus America

Koneksa and Beacon Biosignals Join Forces for Clinical Trial Examining EEG Biomarkers in Sleep and Neurologic Disorders

Wednesday, June 14, 2023

Koneksa, a company specializing in evidence-based digital biomarkers, has announced a new partnership with Beacon Biosignals, a leading computational neurodiagnostics company. The collaboration aims to conduct a clinical trial that explores the integration of Beacon's at-home electroencephalogram (EEG) technology into Koneksa's Neuroscience Solution Toolkit. Beacon's platform utilizes advanced machine learning algorithms to maximize insights into brain activity, providing comprehensive data analysis and visualization capabilities for sponsors. This partnership holds promising prospects for investigating sleep and neurologic disorders using EEG biomarkers in a more accessible and efficient manner.

Koneksa, an evidence-based digital biomarkers company, has announced a partnership with Beacon Biosignals, a computational neurodiagnostics company, for the LEARNS (A basket observational study to determine usability, analytical validity, clinical validity, and biomarker discovery for at-home EEG, wearable, and mobile device-collected objective measurement of disturbed sleep and neurologic disorders) clinical validation study. This syndicated, observational study aims to explore biomarkers, evaluate the usability and validity of measures related to sleep and neurologic disorders using at-home EEG, wearables, and smartphones.

The LEARNS study will specifically investigate the integration of Beacon Biosignals' at-home EEG technology into Koneksa's Neuroscience Solution Toolkit. Parkinson's disease, narcolepsy, obstructive sleep apnea, Alzheimer's disease, Huntington's disease, and mild cognitive impairment are among the current cohorts participating in the study.

Koneksa CEO Chris Benko emphasizes the potential of evidence-based digital biomarkers to revolutionize healthcare and drug development in clinical trials. The collaboration with Beacon Biosignals will enable the integration of digital solutions into clinical trials, providing real-time, data-driven insights and accelerating the identification of treatment signals.

Dr. John Wagner, Chief Medical Officer of Koneksa, notes that the LEARNS study aims to expand the range of digital modalities and diseases covered by the Koneksa solution. Beacon Biosignals' mobile EEG technology will be integrated into the platform, offering a comprehensive set of validated and scalable digital measures to sponsors.

Jacob Donoghue, Co-Founder and CEO of Beacon Biosignals, highlights the shared commitment to innovation and developing tools that advance drug development and benefit patients. The partnership with Koneksa aligns with their dedication to pioneering breakthrough solutions.

The LEARNS study will assess the validity of smartphone-based motor, speech, and cognitive assessments compared to gold-standard tools. It will also explore the potential of combined assessments to identify diagnostic features in specific cohorts. The study aims to expand the understanding of digital biomarkers in neuroscience research and development.

Koneksa welcomes industry participation in the LEARNS study through the LEARNS Access Program. Sponsors involved in the program will have the opportunity to provide input on the study's protocol and cohort design, as well as early access to raw data, analytical tools, and study results.

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