Cumulus Neuroscience commences clinicalstudies of digital biomarker platform indegenerative neurological diseases

May 25, 2022
  • Cumulus’ integrated platform combines multiple digital Central NervousSystem (CNS) measurement tools with AI analytics
  • The platform enables real-world, longitudinal assessments of diseaseprogression to accelerate CNS clinical trials
  • CNS-101 and CNS-102 studies will assess the platform in early-stageAlzheimer’s Disease (AD) dementia, Amyotrophic Lateral Sclerosis (ALS) andFrontotemporal Dementia (FTD) patients

Brian Murphy, Cumulus Neuroscience’s Chief Scientific Officer, said: “Currentstandard measurement tools for dementia, such as clinician administered scales,only give a snapshot in an atypical environment and can suffer from day-to-dayvariation and other measurement errors. As such, they limit the precision and abilityto measure an effect in current CNS clinical trials. Previous field-testing withdementia 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 providingmore precise, longitudinal measures of cognitive decline. Our technology is alreadybeing used in clinical trials of new treatments for Alzheimer’s, and these studies willprovide additional validation, of its sensitivity to change over time.”

Cumulus’ approach has been guided by nine of the world’s leading pharmacompanies and combines a varied set of CNS measurement domains – includingneurophysiology, speech, cognition, sleep and mood – within a single, consolidateddigital platform accessible via a hand-held tablet device and time-linked to afunctional EEG measure of brain activity. The platform combines thesemeasurements with advanced AI and data analytics techniques. This facilitatesrepeated at-home assessment to gather longitudinal data and more accuratelydiscern subtle trends in disease progression. This greater precision is designed toaccelerate clinical trial pathways and improve outcomes in the development of newmedicines for CNS disorders.

“Previous field-testing with dementia patients has shown thatCumulus’ platform is suitable for at-home use, and so thesestudies are a great opportunity to assess its potential inproviding more precise, longitudinal measures of cognitive decline.” Brian Murphy Ph.D. CSO, Cumulus Neuroscience

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

The CNS-102 study, run in collaboration with Professor Orla Hardiman of TrinityCollege 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 andFTD matched with healthy controls. The data obtained at-home will be comparedwith a standard measure typically used in clinical trials for tracking change in ALSand FTD, and with standardised neuropsychological measures of cognitive function.

Dr Kinan Muhammed, Chief Investigator of the CNS-101 study at the lead site atOxford University Hospital, said: “We’re pleased to be working with Cumulus toinvestigate ways to improve measurement in these devastating diseases. Theplatform is specifically designed to address several key parameters in theassessment of CNS disease progression. The frequent at-home approach tosampling data is intended to lower patient burden and could improve the sensitivityand success rate for future clinical trials in dementia”