New trial aims to advance research in diseases like Parkinson’s

2 companies partner to find EEG biomarkers to monitor symptoms

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by Andrea Lobo |

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Koneksa has partnered with Beacon Biosignals to launch a clinical trial focused on advancing research in neuroscience, including Parkinson’s disease, with an aim to develop electroencephalogram (EEG) biomarkers.

EEG technology has long been used to measure the brain’s electrical activity and identify evidence of neurological disorders like Parkinson’s disease. It works by detecting abnormalities in brain waves.

The new collaboration between these two companies seeks to integrate Beacon’s at-home EEG technology into Koneksa’s Neuroscience Solution Toolkit, a platform to monitor patients’ neurological symptoms.

Their LEARNS study — officially titled “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” — will investigate potential biomarkers and evaluate the efficacy and validity of at-home EEG, wearables, and smartphone-based assessments in neurological and sleep disorders.

“The utilization of evidence-based digital biomarkers is the key to transforming healthcare,” Chris Benko, Koneksa’s CEO, said in a press release, adding, “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.”

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Koneska, Beacon aim to discover EEG biomarkers in neurology

The observational study will compare the data collected through Koneksa’s neuroscience solution, incorporating the Beacon Biosignals platform, with in-clinic polysomnography — a sleep exam used to diagnose sleep problems and the current gold standard in the field.

Patients already enrolled in the LEARNS study include those with Parkinson’s, sleep disorders, Alzheimer’s disease, Huntington’s disease, and mild cognitive impairment.

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.

By analyzing the collected data, the study aims to identify EEG biomarkers, assess the usability of the technology, and determine the validity of the measurements in diagnosing and monitoring these disorders.

“The LEARNS study seeks to generate evidence to extend the Koneksa solution to new digital modalities and diseases,” said John Wagner, MD, PhD, chief medical officer at Koneksa.

“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,” he added.

The Koneksa Neuroscience Solution Toolkit allows the monitoring of patients’ data using multiple devices to assess symptoms associated with neurological disorders. It integrates key measures, including vital signs, speech, tremors, gait and balance, cognition, sleep, and physical activity. The platform can be expanded as a result of the LEARNS study, the companies say.

“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,” said Jacob Donoghue, MD, PhD, co-founder and CEO at Beacon Biosignals.

The Beacon platform develops at-home EEG technology applying machine-learning algorithms to maximize insights into brain activity. It provides data visualization and analysis capabilities. The platform aims to accelerate clinical trials and contribute to developing new treatments for neurological diseases.

“We are excited to partner with Koneksa on the LEARNS trial. This opportunity will expand the reach of Beacon’s EEG-based precision neurodiagnostics to more sponsors, and will provide critical validation of methodology that we believe could be transformational to patients,” said Christine Vietz, PhD, chief research and development officer at Beacon.

Koneska has opened the LEARNS Access Program, inviting sponsors to participate in the research initiative. Sponsors who join the program will have the opportunity to provide input on the final study design. Additionally, they will gain early access to raw data, analytical tools, and results, allowing them to leverage the findings to further their own research efforts, the company said.