Ad Scientiam Collaborates with Merck KGaA to Launch Innovative Digital Clinical Study for Generalized Myasthenia Gravis

The study will explore how wearables, smartphone-based functional tests, and ePROs could detect changes in disease trajectory in real-world conditions

PARIS, FRANCE, November 13, 2025 /EINPresswire.com/ -- Ad Scientiam today announced a collaboration with Merck KGaA, Darmstadt, Germany, a leading science and technology company, to launch a prospective, multi-center pilot study exploring the feasibility of an investigational software as a medical device designed to support the management of people living with generalized Myasthenia Gravis (gMG). The study will explore how wearable technologies, smartphone-based functional tests, and electronic patient-reported outcomes (ePROs) could detect changes in disease trajectory in real-world conditions.

Bridging gaps in disease monitoring:
Myasthenia Gravis is a rare autoimmune neuromuscular disease marked by fluctuating muscle weakness. Many patients remain insufficiently controlled despite available therapies, often struggling to detect or communicate subtle changes in their average state amid daily fluctuations in symptoms. At the same time, physicians lack more continuous, objective tools to complement traditional clinical assessments.

This investigational software as a medical device is being developed to address these gaps by uniting three digital health components in a single, patient-centered solution:
- Mobile application: enabling objective data collection through unsupervised active functional tests and electronic questionnaires.
- Wearable activity monitor: passive monitoring of physical activity, heart rate, breathing, and sleep.
- Cloud platforms: extracting digital biomarkers and building exploratory disease trajectory models.

Measuring what matters in daily life:
An exploratory study applying this software as a medical device is being prepared to be launched in selected European countries in 2026. Its primary goal is to explore the feasibility of using digital measures collected by this novel software as a medical device to detect changes in disease trajectory in adults with generalized Myasthenia Gravis over a 12-month period, under real-life, unsupervised conditions.

Patient-centric innovation:
By combining passive data, active functional tests, and ePROs, this software as a medical device aims to provide patients with gMG a more continuous and objective way of following their condition.

“This study is an important first step to explore the feasibility of such a digital platform in real-world, unsupervised conditions. By turning everyday digital measures into a clearer view of disease trajectory, we aim to provide clinicians with more continuous, objective data and give patients a simpler way to recognize and share subtle changes. The results will help lay the groundwork for larger trials and, ultimately, digital tools that could one day transform how neuromuscular disorders like Myasthenia Gravis are monitored and managed.” - Dr Loïc Carment, PhD. Chief Scientific Officer of Ad Scientiam.

About Ad Scientiam:
Ad Scientiam is committed to improving patient care by continuously monitoring the progression of severe and disabling diseases in real-life settings. This approach is essential for delivering more effective and personalized care.
The company develops and clinically validates digital biomarkers that capture subtle and often hard‑to‑detect fluctuations in disease activity. These biomarkers are derived from data collected through everyday digital tools such as smartphones and are processed with proprietary algorithms.
The company’s expertise is recognized by leading hospital institutions across Europe, the United States, and Canada, and by major pharmaceutical partners including Sanofi, Alexion, Kyowa Kirin, Vertex, Merck KGaA, Darmstadt, Germany, and Biogen. MSCopilot^®, a CE‑marked Software as a Medical Device, is classified as Class IIa under the EU Medical Device Regulation (MDR). Beyond MS, Ad Scientiam is validating new medical devices across various fields, including neuroscience, rare diseases, and mental health.
Ad Scientiam’s Quality Management System is fully compliant with ISO 13485.
Contact: press@adscientiam.com

Saad Zinaï
Ad Scientiam
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