Cumulus Neuroscience, a global digital health company, announces the start of two validation trials – CNS-101 and CNS-102. 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 pharma companies, and Innovate UK, 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.”