Beacon says its platform unlocks longitudinal, at-home EEG technology which applies machine-learning algorithms to ‘maximize insights into brain activity and empower sponsors with comprehensive data analysis and data visualization capabilities.’
Chris Benko, CEO, Koneksa, said: “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 measures.”
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’ (LEARNS), is a syndicated, observational study to discover biomarkers and determine the usability and validity of measures of sleep and neurologic disorders collected using at-home EEG, wearables, and smartphones.
The 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 study include Parkinson’s disease, narcolepsy, obstructive sleep apnea, Alzheimer’s disease, Huntington’s disease, and mild cognitive impairment.
Utilizing digital biomarkers
Benko added: “The utilization of evidence-based digital biomarkers is the key to transforming healthcare.
“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 measures.”
John Wagner, is chief medical officer at Koneksa. He said the study is looking to generate evidence to extend Koneksa’s 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.”
Cognitive assessments vs gold-standard tools
The 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. LEARNS has the potential to expand not only the Koneksa platform, but also the entire field’s understanding of digital biomarkers in neuroscience R&D.
Koneksa’s extensive commitment to research includes the potential for industry participation in studies. Sponsors who participate in the LEARNS Access Program will have input on final protocol and cohort design, as well as early access to raw data, analytical tools, and results.
“Partnering with Koneksa is a testament to our dedication to pioneering innovation,” said Jacob Donoghue, co-founder and CEO, Beacon Biosignals.
“With our shared science-first ethos, we are united in our relentless pursuit to develop cutting-edge tools that revolutionize drug development and accelerate the delivery of life-changing therapies to patients.”