Cumulus Neuroscience Presents Data at AAIC 2025 Annual Meeting and Technology and Dementia Preconference

Analysis of first-in-class CNS-101 study validates that at-home endpoints showed greater separation with Alzheimer's pathology (pTau217) than the benchmark endpoint Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog 13) over the study time-course

BELFAST, Northern Ireland, July 28, 2025 /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 observational study CNS-101 at the Alzheimer's Association International Conference 2025 in Toronto, Ontario, Canada. Using the proprietary 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, "Frequent at-home multimodal measurements are more sensitive to progression than the gold-standard clinic-based ADAS-Cog composite scale" which featured data confirming repeated home-based digital cognitive endpoints are more sensitive to disease progression than the ADAS-Cog 13 composite benchmark, the primary cognitive scale used in Alzheimer's clinical trials today to determine drug efficacy. Additionally, passive electroencephalography (EEG) markers and naturalistic language-based markers collected with the NeuLogiq Platform are similarly powerful at detecting dementia progression as the ADAS-Cog 13, which requires a trained clinician and takes ~45 minutes to administer.

"Clinic-based endpoints reflect snapshots in time, which limits the ability to track true disease progression and therapeutic efficacy in clinical research. Additionally, these endpoints lack sensitivity, objectivity, and are not scalable," 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. This first-in-class study 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 now have evidence that repeated real-world measurements at home provide higher statistical power than ADAS-Cog and could enable leaner study designs. We are deeply grateful to all the study participants and research collaborators."

Additional analysis demonstrated that individual digital endpoints can enable streamlined study designs which may reduce overall costs, accelerating results leading to earlier go/no go decisions. In collaboration with the Cumulus Pharma Advisory Group, Cumulus will validate whether a digital composite measure may provide additional study power.

"It's promising to see the increased sensitivity and statistical power of digital biomarkers from the wealth of data collected both at home and in the clinic in CNS-101," said Dr. Emer MacSweeney, Co-Founder & CEO of Re:Cognition Health's Brain and Mind Clinics which served as a leading CNS-101 clinical site. "The burden on study participants and patients is an important consideration when designing a clinical study in Alzheimer's Disease. Studies like CNS-101 are important to show the validity and sensitivity of digital biomarkers in developing CNS therapies and reducing the impact on patients and clinicians alike."

Alzheimer's 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. While there is no known cure, there are currently over one hundred Alzheimer's disease clinical trials underway.  

In the CNS-101 Study, patients with dementia (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 and Re:Cognition Health's Brain and Mind Clinics in Plymouth and Guildford, for a 12-month repeated sampling study. Plasma samples were collected to confirm disease pathology. 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.

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