September 19, 2023 Source: drugdu 205
Sanofi and Ad Scientiam have partnered to launch an international, multicentre, longitudinal study to evaluate the ability of medical software, MSCopilot, to assess disability progression in people with multiple sclerosis (MS).
The main objective of the MS-DETECT study, which explores digital biomarkers of MS, is to determine whether the MSCopilot software can effectively identify subtle and early signs of disability worsening.
MS is a chronic immune-mediated, neurodegenerative disease of the central nervous system that currently affects 2.8 million people globally.
The study will include 314 people with MS and will be conducted in the US, Canada, Germany, Italy, Spain, Denmark and France.
Coordinating investigator and chairman of the study steering committee, professor Patrick Vermersch, believes that "these novel digital biomarkers are key to helping clinicians make appropriate treatment decisions and, ultimately, improve patients’ care."
As part of the agreement, the study will draw upon Ad Scientiam’s expertise in MS and will be financially supported by Sanofi.
MSCopilot aims to improve clinical evaluation assessments for people with MS, which usually rely on the Expanded Disability Status Scale (EDSS).
Ad Scientiam's software medical device will address four dimensions: ambulation/mobility, upper extremity function, cognition, and low-contrast visual activity.
The MS-DETECT study will also focus on the assessment of the MSCopilot’s performance, safety, usability and satisfaction with the solution.
Currently, several investigative sites have been initiated in North America and Europe, and the first patients are expected to participate during the third quarter of 2023.
"Disability worsening in MS has been recently redefined and we now know that this progression can occur independently of relapses," said Su-Peing Ng, global head of medical affairs, specialty care at Sanofi.
"With MS-DETECT, we have an opportunity to develop a digital solution to help detect and monitor the effects of smouldering disease, and evolve treatment goals for MS patients," she added.
Dr Saad Zinaï, chief medical officer at Ad Scientiam, said: “MS-DETECT is a pioneering large-scale longitudinal study that explores digital biomarkers for the early detection of disease progression. This study will provide important data to both clinicians and people living with MS.”
https://www.pmlive.com/pharma_news/sanofi_and_ad_scientiam_partner_to_assess_ms_disability_progression_1500003
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