BELFAST, Northern Ireland, Oct. 13, 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 at the International Society for CNS Clinical Trials and Methodology (ISCTM) Autumn Conference and the 38th European College of Neuropsychopharmacology (ECNP) Congress in Amsterdam, the Netherlands.
Traditional clinical trials for disorders and diseases of the central nervous system (CNS) like Major Depressive Disorder (MDD) and Alzheimer’s Disease (AD) are long, costly and can be burdensome for participants. The NeuLogiq® Platform was purpose-built by Cumulus in collaboration with 10 top biopharma companies to generate objective clinical quality data through frequent, repeated digital measurements collected in clinic or in the home setting. These data can provide study sponsors with critical data and insights that allow for earlier decision-making, resulting in cost savings.
The first poster, presented at ECNP, titled, “Deploying User-Friendly Portable EEG to Measure Response to a Novel Antidepressant with Resting and Task-Driven Neurophysiological Endpoints,” reported interim data from a Phase 1b study conducted in partnership with Delix Therapeutics. The poster featured data evaluating the pharmacodynamics, safety, and tolerability of a novel neuroplastogen, DLX-001, in people with MDD. The Phase 1b study was designed to show early evidence of target engagement and neuroplastic effects of DLX-001 in patients with MDD, and used the proprietary NeuLogiq Platform to gather data via high-frequency repeated measurements of cognition and neurophysiology.
“We are pleased that this platform supported evaluation of target engagement and cognitive effects of DLX-001 – a novel neuroplastogen – in our Phase 1b study in individuals with MDD,” said Dr. Aaron Koenig, Chief Medical Officer of Delix Therapeutics. “Low-burden markers like these compliment other traditional translational measures and show promise as scalable approaches for derisking clinical programs earlier in development.”
On October 21st, Dr. Aaron Koenig will join Brian Murphy, PhD, Co-founder and CSO of Cumulus Neuroscience, for a webinar titled “Neuropsychiatry Clinical Trials: Evolving with Portable EEG and Digital Endpoints,” where the findings from the Delix DLX-001 Phase 1b study will be discussed in more detail. Click here to learn more.
The second poster, presented at ECNP, titled “Scalable Digital Endpoints Improve Sensitivity to Cognitive Change and Can Drive Efficiencies in CNS Clinical Trials,” modeled data from Cumulus Neuroscience’s flag-ship CNS-101 study which collected repeat measures in the home over the course of 12 months with the NeuLogiq Platform. The study, which included 59 patients living with mild dementia and 60 age-match controls, demonstrated that brief but repeated home-based digital cognitive endpoints were more sensitive to change than the ADAS-Cog 13 composite benchmark. The power to track progression varied by assessment modality but showed cognitive tests could deliver substantially higher study power than ADAS-Cog, with a cohort of under 50% the size – highlighting that individual digital endpoints can enable streamlined study designs by allowing for reduced cohort sizes.
The third poster presented at ISCTM, titled “Streamlining CNS Clinical Research with Digital Endpoints – the Trade-off Between Shorter Versus Smaller Trial Designs,” featured data modeling the impact of a 10 – 50% reduction in patient numbers compared to a reduction in trial duration on total study costs and length for Phase II trials in AD and MDD. The analysis, which included 77 industry trials in AD and 55 in MDD, suggests that reducing cohort size saved more time and costs in 81% of recent clinical AD and MDD trials. These time and cost savings were driven by the compounding benefits of smaller cohorts – both lower up-front costs, and shorter recruitment timelines leading to an earlier readout.
“Alongside the team at Delix, we are excited to share data from their Phase 1b study for DLX-001 showing how NeuLogiq provided early evidence of target engagement and neuroplastic effects, in addition to confirming that EEG effects seen with conventional lab-grade equipment can also be measured with easy-to-use dry EEG technology,” said Brian Murphy, PhD, Co-founder and Chief Scientific Officer of Cumulus Neuroscience.
“To build on this, at ECNP we presented a second poster including data from our CNS-101 study which demonstrated that NeuLoqiq digital endpoints repeated at home were more sensitive to change than the ADAS-Cog 13 composite benchmark. This further highlights the potential for digital measures to enable streamlined study designs, reduced cohort sizes, and decreased recruitment timelines – allowing earlier decision making in clinical trials. At ISCTM, we presented an analysis of a large sample of Alzheimer’s and depression studies leveraging an established methodology to quantify the potential time and cost savings associated with deploying digital measures, which can allow for adaptive trial designs and earlier go/no-go decisions in clinical development.”
Cumulus supports precision in CNS clinical trials for its industry partners by enabling in-clinic and remote monitoring of patients across multiple domains of brain function. To learn more, visit www.cumulusneuro.com.
About Alzheimer’s Disease (AD)
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.
About Major Depressive Disorder (MDD)
Also known as clinical depression, MDD is a common mental health condition characterized by persistent feelings of sadness, hopelessness, and loss of interest or pleasure in activities. MDD is one of the most common mental health disorders, affecting an estimated 6-7% of adults worldwide. It can occur at any age, and it is more prevalent in women than men. Antidepressant medications and psychotherapy are common treatments for MDD, but some individuals may not respond well to these options, leading to an unmet need for alternative or complementary treatments.
About Cumulus Neuroscience
Our mission is to generate the data and insights required to accelerate the diagnosis and management of central nervous system (CNS) disorders for millions of patients and caregivers around the world. At Cumulus Neuroscience we are advancing NeuLogiq®, an AI-based, multi-domain digital biomarker platform designed with 10 of the world’s leading pharma companies. This novel platform provides the critical data and insights needed for faster, more robust and cost-effective decision-making in clinical trials and patient care. NeuLogiq enables study sponsors to capture large amounts of real-world clinical data repeatedly over time, across multiple behavioral and physiological domains, in the clinic and at home. Together with machine learning (ML) analytics, Cumulus simplifies and improves the robustness of CNS clinical trials, providing objective assessment of study inclusion and treatment outcomes.
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About Delix Therapeutics
Delix Therapeutics is a clinical-stage neuroscience company focused on harnessing the power of novel neuroplasticity-promoting therapeutics to better treat patients struggling with difficult-to-treat neuropsychiatric and neurological disorders. The company’s compounds are small molecules capable of rapidly inducing structural and functional neural changes in targeted areas of the brain. Through its novel Neuroplastogen Platform, Delix is pioneering a new class of fast-acting outpatient pharmacotherapies and rapidly advancing through preclinical and clinical development to bring patients FDA-approved medicines that are intended to serve several unmet needs and enhance the psychiatric treatment paradigm for patients and providers.
World Health Organisation Factsheet on Depression: https://www.who.int/news-room/fact-sheets/detail/depression
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