Cumulus Neuroscience is a digital health company that focuses on advancing neuroscience clinical trials through improved data made the announcement yesterday (Wednesday 31).
The real-world study will compare those with early-stage AD with healthy controls over the course of a year. The University of Cambridge and the University of Oxford are the lead recruitment sites for the study.
Using Cumulus’ dry-sensor electroencephalogram (EEG) headset with their digital platform, the goal is to assess people, in their familiar environments avoiding travel to research facilities. The patients’ cognitive performance and their brain waves during daily life. Study results will be compared with standard assessments normally used in AD clinical trials, including cognitive and blood biomarkers.
James Rowe, chief investigator, and professor of cognitive neurology at the University of Cambridge, said: “Clinical trials of Alzheimer's disease and mild cognitive impairment can be challenging for many reasons. Reliance on specialist, centralized test centers increase participants’ burden and reduces sensitivity to natural day to day variation in symptoms.
“The Cumulus Platform brings the clinical trial to the patient. To measure brain function, repeatedly over time, and in the comfort of a participant’s own home, is a major step forward for a new generation of clinical trials.”
Cumulus said patient enrollment for central nervous system (CNS) studies can be difficult, and compliance limited. The company said last year, across the entire UK, only 61 patients living with AD were recruited into late-stage trials supported by the National Institute for Health and Care Research (NIHR). The collective clinical study sites involved in the Cumulus Neuroscience CNS-101 study were able to fully enroll 59 patients in less than a year.
Brian Murphy, founder, and chief scientific officer at Cumulus, said: “We’re encouraged to see high patient compliance rates with the at-home study protocol in our interim analysis.
“This engagement is a testament to the commitment of patients and caregivers to advance the understanding of Alzheimer's disease, and the support they receive from our clinical partners.”
CNS-101 study participants use a tablet to log onto the Cumulus platform app, and perform a variety of tasks measuring working memory, episodic memory, executive function, decision making, language, and mood, while wearing the Cumulus headset which records EEG brain waves. They also wear a headband at night to record brain waves while they sleep and monitor sleep quality over the course of the study. Data from the headsets and sleep headbands are recorded and uploaded onto the secure Cumulus Platform using anonymized codes, via the participant’s home Wi-fi.
The details of this study are expected to be presented at upcoming medical conferences, with full results expected to be presented in early 2024.