- Analysis of first-in-class CNS-101 study validates that patients living with mild Alzheimer’s dementia are capable and willing to participate in intensive home-based functional neurophysiology studies, and data procured at home can achieve discriminative power that is comparable to the Alzheimer’s Disease Assessment Scale-Cognitive Subscale (ADAS-Cog), a traditional composite scale.
BELFAST, Northern Ireland and CAMBRIDGE, Mass., Aug. 1, 2024 /PRNewswire/ -- Cumulus Neuroscience (Cumulus; The Company), a global digital health company focused on advancing neuroscience clinical trials and patient care through improved data, presented data from their real-world feasibility study CNS-101 at the Alzheimer’s Association International Conference 2024 in Philadelphia, Pennsylvania. Using the proprietary Cumulus NeuLogiq™ Platform to gather data via repeated at-home sampling, the study was conducted in collaboration with the University of Cambridge.
Cumulus presented a poster titled, “A longitudinal real-world study in patients with Alzheimer’s Disease dementia using frequent multi-domain digital measurements performed at-home on the Cumulus NeuLogiq™ Platform: usability and feasibility findings,” which demonstrated that objective measures of a range of domains, including electroencephalography (EEG), are user-friendly and suitable for repeated at-home use by patients and older controls. Patients living with Alzheimer’s dementia (AD) and healthy controls exhibited high compliance rates with active tasks in the study protocol (79.2%; 89.9%, respectively) contributing to a wealth of behavioral and EEG data despite initial reservations about using technology at home. Between weeks 2 and 52, participants reported a 150% increase in ease of use and a 24% decrease in needing assistance to complete sessions, highlighting the platform’s potential for successful integration into their daily lives. Importantly, despite the intensive at-home sampling schedule, drop-out rates in this study were modest (AD patients, 27%; healthy controls, 10%).
“While clinic-based biomarkers are effective in tracking disease progression and therapeutic efficacy in clinical research, they are not scalable and lack objectivity,” said Brian Murphy, PhD, Founder and Chief Scientific Officer of Cumulus. “Our CNS-101 study was executed in collaboration with the Cumulus Pharma Advisory Group which is comprised of leading scientists from ten top pharma companies. It has validated that patients living with Alzheimer’s dementia are capable and willing to participate in clinical studies that include at-home longitudinal measures. Our NeuLogiq platform, which includes an award-winning FDA-cleared EEG headset, is user-friendly and suitable for repeated at-home use. We were thrilled to achieve high adherence and overall low dropout rates, which is notable given the intense nature of this 12-month study protocol. We are deeply grateful to all the study participants and research collaborators.”
AD is a progressive disease that affects brain function, memory, and other cognitive abilities. It is the most common cause of dementia, affecting millions of people worldwide. Symptoms usually develop slowly and worsen over time, including memory loss, confusion, difficulty with language and communication, mood swings, and changes in behavior and personality. Currently, there is no known cure for AD.
A second poster titled, “Machine-learning analysis of real-world multimodal data collected autonomously at home detects dementia as precisely as a traditional composite scale” was presented which demonstrated that patients using digital technology autonomously in the home can yield data that is comparable to the discriminative power of the burdensome clinician-administered Alzheimer’s Disease Assessment Scale-Cognitive Subscale (ADAS-Cog), a traditional composite scale. Importantly, these data demonstrated that behavioral and EEG-based measures aligned strongly with established benchmarks, and with the literature on functional impairment in AD, constituting positive early evidence for construct validity and technical feasibility, ultimately enabling objective precision measurement of disease severity at scale.
In the CNS-101 Study, patients with AD (N=59, ACE-III scores >60 and ≤88) and a matched cohort of healthy controls (N=60) were recruited across 7 sites in the UK including Cambridge and Oxford Universities for a 12-month repeated sampling study. Participants were asked to complete repeated home-based sessions using the platform during the day, and to wear a sleep EEG device at night. Day sessions with a duration of approximately 30 minutes included 8 behavioral assessments on a mobile tablet (memory, executive function, affective processing and language) while synchronized EEG was recorded using the Cumulus 16-lead EEG headset. A staggered longitudinal protocol followed with burst sampling tapering to periodic sampling over the year. Benchmark paper-based assessments (including ADAS-Cog) and self-reported usability were collected at months 0, 6, and 12. Blood plasma was collected at months 6 and 12 for later biomarker analysis.
Cumulus supports precision in CNS clinical trials for its industry partners by enabling remote monitoring of patients across multiple domains of brain function. To learn more, visit www.cumulusneuro.com.
About Cumulus Neuroscience
With a mission to generate the data and insights required to accelerate diagnosis and management of central nervous system (CNS) disorders for millions of patients and caregivers around the world, Cumulus Neuroscience is advancing NeuLogiq™, an AI-based, multi-domain digital biomarker platform to enable better, faster decision making in neurology and neuropsychiatry clinical trials and patient care. Designed for and with 10 of the world’s leading pharma companies, the platform enables decentralized trials, and is already making a difference in the development of therapies for Alzheimer’s Disease, depression and schizophrenia.Designed to provide an industry-wide standard for real-world measurement of disease progression, Cumulus combines patented technology, in-house expertise and key industry partnerships to capture large amounts of real-world, clinical data repeated over time, across multiple behavioral and physiological domains in the patient’s home – all with an EEG headset synced to a novel, tablet-based neuro-assessment platform. Together with machine learning (ML) analytics and the world’s largest database of annotated, longitudinal, neurofunctional data, Cumulus simplifies and improves the robustness of neuroscience clinical trials to provide the best and most cost-effective assessment of CNS treatment outcomes.
The Company is supported by highly experienced specialized investors, DDF/SV Health Investors, LifeArc and Future Fund, and a world-class Scientific and Technical Advisory Board.
FOR MORE INFORMATION
Julie DietelFINN Partners for Cumulus
Tel: 978.502.7705
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