Cumulus Neuroscience commences clinical studies of digital biomarker platform in degenerative neurological diseases

• Cumulus' integrated platform combines multiple digital Central Nervous System (CNS) measurement tools with AI analytics
• The platform enables real-world, longitudinal assessments of disease progression to accelerate CNS clinical trials
• CNS-101 and CNS-102 studies will assess the platform in early-stage Alzheimer's Disease (AD) dementia, Amyotrophic Lateral Sclerosis (ALS) and Frontotemporal Dementia (FTD) patients

BELFAST, Northern Ireland, May 25, 2022 /PRNewswire/ -- Cumulus Neuroscience, a global digital health company, announces the start of two validation trials – CNS-101 and CNS-102 – supported by a group of leading global pharma companies and Innovate UK. The studies will investigate the potential benefits of Cumulus' integrated physiological and digital biomarker platform in quantifying cognitive decline over time in patients with dementia, across AD, ALS and FTD.

Brian Murphy, Cumulus Neuroscience's Chief Scientific Officer, said: "Current standard measurement tools for dementia, such as clinician administered scales, only give a snapshot in an atypical environment and can suffer from day-to-day variation and other measurement errors. As such, they limit the precision and ability to measure an effect in current CNS clinical trials. Previous field-testing with dementia patients has shown that Cumulus' platform is suitable for at-home use, and so these studies are a great opportunity to assess its potential in providing more precise, longitudinal measures of cognitive decline. Our technology is already being used in clinical trials of new treatments for Alzheimer's, and these studies will provide additional validation of its sensitivity to change over time."

Cumulus' approach has been guided by nine of the world's leading pharma companies and combines a varied set of CNS measurement domains – including neurophysiology, speech, cognition, sleep and mood – within a single, consolidated digital platform accessible via a hand-held tablet device and time-linked to a functional EEG measure of brain activity. The platform combines these measurements with advanced AI and data analytics techniques. This facilitates repeated at-home assessment to gather longitudinal data and more accurately discern subtle trends in disease progression. This greater precision is designed to accelerate clinical trial pathways and improve outcomes in the development of new medicines for CNS disorders.

The UK multi-site CNS-101 study will assess the feasibility of using these repeated digital measures at home in patients with early-stage AD dementia compared with healthy controls. 120 participants will use the platform at home over the course of one year, and data will be compared with standard assessments typically used in AD dementia clinical trials.

The CNS-102 study, run in collaboration with Professor Orla Hardiman of Trinity College Dublin and Consultant Neurologist at Beaumont Hospital, will assess at-home use of the platform for a period of up to 37 weeks in individuals with ALS and FTD matched with healthy controls. The data obtained at-home will be compared with a standard measure typically used in clinical trials for tracking change in ALS and FTD, and with standardised neuropsychological measures of cognitive function.

Dr Kinan Muhammed, Chief Investigator of the CNS-101 study at the lead site at Oxford University Hospital, said: "We're pleased to be working with Cumulus to investigate ways to improve measurement in these devastating diseases. The platform is specifically designed to address several key parameters in the assessment of CNS disease progression. The frequent at-home approach to sampling data is intended to lower patient burden and could improve the sensitivity and success rate for future clinical trials in dementia."

About Cumulus Neuroscience 

Cumulus Neuroscience has created the next-generation, gold standard integrated physiological and digital biomarker platform for measuring functional brain health. Uniquely, it combines neurophysiological monitoring (EEG) time-linked with a range of assessment tools for frequent at-home use. In clinical trials it provides critical data and insights to accelerate the delivery of more effective central nervous system (CNS) therapies to patients. 

Our innovative platform has been designed in collaboration with leading global pharmaceutical companies to greatly improve the speed, robustness and cost-effective execution of neuroscience clinical trials by allowing better and timely assessment of drug candidates earlier in development, with the aim to provide an industry-wide standard for real-world measurement of disease progression and treatment response. 

Our platform has been developed to capture large amounts of real-world lab-quality data through time across multiple behavioural and physiological domains by tracking physiology, functions and symptoms in the patient's home. The platform also provides cutting-edge AI-based data analysis allowing it to provide the best and most cost-effective assessment of CNS treatment outcomes. 

Cumulus Neuroscience is confident that it can play an important role in assisting its pharma and biotech partners to develop transformational therapies to address multiple important neurodegenerative and neuropsychiatric diseases, where treatment options are extremely limited. 

The Company is supported by highly experienced specialised investor the Dementia Discovery Fund (DDF) as well as LifeArc and Future Fund, together with a world-class Scientific and Technical Advisory Board.

FOR MORE INFORMATION 

Cumulus Neuroscience Brian Murphy, CSO & Co-Founder[email protected]Tel: +44 28 9264 6600 

MEDiSTRAVA Consulting Frazer Hall, Evelyn McCormack, George Underwood[email protected]Tel: +44 (0)20 7638 9571

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SOURCE Cumulus Neuroscience