Koneksa Announces Partnership with Beacon Biosignals for Clinical Trials in Sleep and Neurologic Disorders Using EEG Biomarkers

Koneksa has announced a partnership with Beacon Biosignals, a computational neurodiagnostics company, to launch a clinical trial to investigate the integration of Beacon’s at-home electroencephalogram (EEG) into the Koneksa Neuroscience Solution Toolkit. The Beacon platform unlocks longitudinal, at-home EEG technology, applies machine-learning algorithms to maximize insights into brain activity, and empowers sponsors with comprehensive data analysis and data visualization capabilities.

The Koneksa-sponsored clinical validation study, “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,” also known as LEARNS, is a syndicated, observational study to discover biomarkers and determine the usability and validity of measures of sleep and neurological disorders collected using at-home tools like wearables, at-home EEG, and smartphones.

The LEARNS study will investigate the Koneksa neuroscience solution, as well as the Beacon Biosignals platform, applied to at-home EEG compared with in-clinic polysomnography, in neurological and sleep disorders. Current cohorts in the LEARNS study include Parkinson’s disease, narcolepsy, obstructive sleep apnea, Alzheimer’s disease, Huntington’s disease, and mild cognitive impairment.

“The utilization of evidence-based digital biomarkers is the key to transforming healthcare,” said Koneksa CEO Chris Benko. “We’re on a mission to revolutionize drug development in clinical trials by harnessing the power of our digital solutions with real-time, data-driven insights. Our collaboration with Beacon BIosignals will enable sponsors to integrate our digital solutions into clinical trials to identify treatment signals earlier and faster than with traditional measurements.”

Koneksa Chief Medical Officer John Wagner, MD, PhD, added, “The LEARNS study seeks to generate evidence to extend the Koneksa solution to new digital modalities and diseases. Beacon’s mobile EEG will join more than a dozen digital health technologies that are already integrated into the Koneksa solution. Our goal is to provide the widest possible range of validated, scalable digital measures to sponsors in one platform.”

The LEARNS study will measure the validity of smartphone-based motor, speech, and cognitive assessments versus gold-standard tools. The study will also evaluate whether assessment combinations can identify diagnostic features at the cohort diagnostic boundary.

Read the full press release here.

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