The presentation featured data demonstrating that patients living with ALS and FTD are willing and able to participate in decentralized clinical trials that include intensive, repeated sampling protocols, while providing positive evidence for task validity and technical feasibility among this vulnerable patient community.
The research also demonstrated that digital remote measurements can be used to stratify healthy subjects and patients, providing positive evidence for task validity and technical feasibility.
Participants with ALS and FTD were able to fully complete all assessments at home using the Cumulus Neuroassessment Platform including the Edinburgh Cognitive and Behavioral ALS Screen (ECAS) and three at-home 25-minute sessions every two weeks to assess multiple domains of brain function - affective processing, language, executive function, memory, and motor skills.
Brian Murphy, founder and chief scientific officer of Cumulus, said: “Detection of cognitive or behavioral changes in patients living with ALS or FTD can be challenging during clinical visits due to a variety of factors including fatigue and white coat syndrome.”
"We are encouraged by the analysis from our CNS-102 feasibility study, which confirms that patients living with these devastating conditions are willing and able to participate in home-based studies with intensive protocols. We are deeply grateful to the patients, caregivers and collaborators who dedicated their time to this important first-in-class study.”
Professor Orla Hardiman, CNS-102 principal investigator, added: “The results of CNS-102 provide preliminary evidence that the Cumulus platform can identify cognitive deficits across these patient groups. Importantly, across study cohorts we saw very high rates of successfully completed sessions, which confirms that the platform is patient friendly and easy to use.”