Merck joins study of digital biomarkers for Parkinson’s disease

Researchers will have access to real-time data, results as trial progresses

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by Patricia Inácio, PhD |

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Note: This story was updated March 27, 2024, to correct that the Michael J. Fox Foundation is not funding the LEARNS study.

Merck, known as MSD outside the U.S. and Canada, has joined the observational LEARNS study to investigate the potential of digital biomarkers to evaluate and predict disease progression in Parkinson’s disease patients.

Merck joined the data syndication partnership for the study, giving its researchers immediate and real-time access to data and results as the trial progresses, said Koneksa, the company leading LEARNS.

Digital biomarkers that can be assessed remotely using smartphones and wearable devices have the potential to aid in diagnosing Parkinson’s and allow patients to begin treatment while still in the disease’s early stages.

“The healthcare community urgently needs better, well-validated measures of Parkinson’s disease progression to inform drug development,” Chris Benko, CEO of Koneksa, said in a company press release. “We are establishing data syndication partnerships as a new form of pre-competitive collaboration that brings together a community around real-time data sharing and analysis throughout our studies to accelerate the validation and adoption of better digital measures.”

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Study to use wrist-worn devices, iPhones to assess biomarker responsiveness

The LEARNS study (NCT06219629) aims to evaluate the reliability and responsiveness of biomarkers across time using mobile electroencephalogram (EEG), wearables, and smartphone-based assessments in neurological and sleep disorders. EEG technology allows researchers to measure the brain’s electrical activity and identify evidence of neurological disorders like Parkinson’s disease.

The study’s full name is 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.

LEARNS will follow as many as 70 patients with Parkinson’s disease for 12 months. Enrollment is underway at clinical sites in Florida and Michigan. The first patient was enrolled in February, according to Koneksa.

The study’s goal is to assess disease progression by evaluating a series of parameters captured remotely with the Koneksa Neuroscience Toolkit, which uses iPhone-based active assessments and passive monitoring from a wrist-worn device.

Data collected from the two-part study will help guide the future development of digital biomarkers of disease progression in Parkinson’s disease.

“Digital technologies provide an opportunity to quantitatively and objectively assess disease progression and treatment effect in people with Parkinson’s disease,” said Aubrey Stoch, MD, head of translational medicine at Merck Research Laboratories.  “As a founding member of Koneksa’s data syndication community, we are excited to collaborate to further the development of digital measures and advance understanding of this debilitating disease.”

Koneksa has been awarded a grant from The Michael J. Fox Foundation for a clinical trial assessing the potential of digital biomarkers to evaluate the severity of vocal abnormalities that can occur in Parkinson’s disease.