Cumulus Neuroscience presented groundbreaking data at the Alzheimer's Association International Conference 2025 in Toronto, demonstrating that at-home digital biomarkers outperform the gold-standard clinical assessment scale used in Alzheimer's drug trials. The company's first-in-class CNS-101 study validated that repeated home-based digital cognitive endpoints showed greater separation with Alzheimer's pathology (pTau217) than the benchmark Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog 13) over the study time-course.
Digital Biomarkers Match Clinical Gold Standard Performance
The study revealed that passive electroencephalography (EEG) markers and naturalistic language-based markers collected with Cumulus's proprietary NeuLogiq Platform are similarly powerful at detecting dementia progression as the ADAS-Cog 13. This finding is particularly significant given that ADAS-Cog 13 requires a trained clinician and takes approximately 45 minutes to administer, while the digital assessments can be completed at home.
"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. "We now have evidence that repeated real-world measurements at home provide higher statistical power than ADAS-Cog and could enable leaner study designs."
Comprehensive 12-Month Observational Study
The CNS-101 study recruited patients with dementia (N=59, ACE-III scores >60 and ≤88) and a matched cohort of healthy controls (N=60) across 7 sites in the UK, including Cambridge and Oxford Universities and Re:Cognition Health's Brain and Mind Clinics in Plymouth and Guildford. The 12-month repeated sampling study collected plasma samples to confirm disease pathology.
Participants completed repeated home-based sessions using the platform during the day and wore a sleep EEG device at night. Day sessions lasting approximately 30 minutes included 8 behavioral assessments on a mobile tablet covering memory, executive function, affective processing and language, while synchronized EEG was recorded using the Cumulus 16-lead EEG headset. The study followed a staggered longitudinal protocol with burst sampling tapering to periodic sampling over the year.
Potential for Streamlined Clinical Trial Design
Additional analysis demonstrated that individual digital endpoints can enable streamlined study designs which may reduce overall costs, accelerating results and leading to earlier go/no-go decisions. The company plans to validate whether a digital composite measure may provide additional study power in collaboration with the Cumulus Pharma Advisory Group, comprised of leading scientists from ten top pharmaceutical companies.
"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."
Addressing Critical Need in Alzheimer's Research
Alzheimer's disease is a progressive condition that affects brain function, memory, and other cognitive abilities, representing the most common cause of dementia and affecting millions of people worldwide. While there is no known cure, there are currently over one hundred Alzheimer's disease clinical trials underway, highlighting the urgent need for more sensitive and scalable assessment tools.
The CNS-101 study validated that patients living with Alzheimer's dementia are capable and willing to participate in clinical studies that include at-home longitudinal measures. The NeuLogiq platform, which includes an award-winning FDA-cleared EEG headset, proved user-friendly and suitable for repeated at-home use.
Cumulus Neuroscience's AI-based, multi-domain digital biomarker platform is designed to enable better, faster decision making in neurology and neuropsychiatry clinical trials and patient care. The platform enables decentralized trials and is already making a difference in the development of therapies for Alzheimer's Disease, depression and schizophrenia.
