Clinical study of digital biomarker platform in degenerative neurological diseases

pharmafile | May 25, 2022 | News story | Research and Development  

Cumulus Neuroscience has announced 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 various neurological conditions.

The studies will investigate the benefits of the platform in patients with dementia, across Alzheimer’s Disorder (AD), amyotrophic lateral sclerosis (ALS), and frontotemporal dementia (FTD).

Brian Murphy, Cumulus Neuroscience’s Chief Scientific Officer, commented: “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.”

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. The CNS-102 study will be run in collaboration with Professor Orla Hardiman of Trinity College Dublin, and Consultant Neurologist and Beaumont Hospital. It 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.

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.”

Ana Ovey

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