Cognito Therapeutics and West Virginia University’s Rockefeller Neuroscience Institute (RNI) have recently unveiled a strategic partnership aimed at establishing a neurotech-enabled learning healthcare system, with an initial focus on treating Alzheimer’s disease and broader applications in mind.
The Brain Health Collaboratory is an ambitious initiative that seeks to advance science, medicine, and public health by combining clinical care, AI-powered research, and continuous data generation. This collaboration will leverage Cognito’s treatment platform and RNI’s unique attributes to create a rural center of excellence for brain health innovation.
Christian Howell, CEO of Cognito Therapeutics, and Dr. Ali Rezai, Executive Chair of RNI, shared their vision for this partnership and the driving forces behind progress in neurotechnology markets.
Cognito received FDA Breakthrough designation for its Spectris headset in 2021 and is currently conducting a fully-enrolled pivotal trial.
Cognito Therapeutics
Cognito Therapeutics, founded in 2016 by neuroscientists Ed Boyden and Li-Huei Tsai, has raised over $200m in private capital to bring a novel disease-modifying treatment to market. Spectris, the company’s headset, administers acoustic and light-based stimulation at a 40 hertz frequency for an hour daily.
Following the FDA Breakthrough designation in 2020, Cognito conducted a six-month early feasibility study with 76 patients, followed by a voluntary 12-month extension to study longer-term outcomes. The company is now in the midst of a pivotal study, fully enrolled with 673 patients and projected to conclude in spring 2026.
In addition to demonstrating a promising safety profile and patient tolerability, Cognito has published data indicating the potential of their “neuroprotective” approach in preserving cognition, brain function, and volume while reducing healthcare costs.
“After 60 days of stimulation at 40 hertz, you can see what’s happening by looking at people’s spinal fluid,” Howell explained. “We’re seeing significant protein expressions in synapses, myelin, and cognitive resilience proteins. At 90 to 120 days under MRI, you can see not just myelin preservation, but those proteins actually having a restorative effect, building synaptic plasticity, and improving glymphatic function.”
Mission, Vision, Decision
Christian Howell, CEO of Cognito Therapeutics (L) with Ali Rezai, M.D., executive chair of the West Virginia University Rockefeller Neuroscience Institute.
West Virginia University
Howell and Rezai came together to explore deeper insights into the biological mechanisms of action in Alzheimer’s and other brain health conditions, with a focus on enhancing clinical, economic, and social aspects of treatment at a population level. The Collaboratory will be housed within RNI, an institution that combines neurology, neurosurgery, psychiatry, radiology, and rehabilitation in a unified unit.
RNI’s extensive network of 47 practice locations, telehealth capabilities, and care for approximately 300,000 patients in a rural area spanning West Virginia, Southwestern Pennsylvania, Eastern Ohio, and Western Maryland positions it as a unique hub for brain health innovation.
“We take care of about 10,000 patients a year with Alzheimer’s disease, about 9,000 with Parkinson’s. And we’re a payer provider as well with our insurance company,” Rezai shared. “Our ecosystem has 330 different physicians and scientists in the neuroscience institute and about 2,400 team members. All of that allows us to really connect the dots.”
Given the at-home nature of the Spectris treatment and the acute impact of Alzheimer’s disease, caregiver engagement is a crucial component of this initiative. RNI offers a caregiver program to support emotional and physical health for families affected by these conditions.
The center is currently co-funded by Cognito and RNI but is expected to attract external support in the future, similar to Rezai’s work in focused ultrasound, which has received state funding and non-profit grants in recent years. “As we gather data showing that we can alter the course of Alzheimer’s with a home-based therapy, demonstrating changes in imaging data, biomarkers, and health economics, we anticipate further funding from government sources, foundations, and donors,” Rezai explained.
Looking ahead, Howell envisions Cognito establishing only a few more Collaboratories, considering the stringent criteria for finding aligned health system leadership and the substantial commitment required for a venture-backed startup running a large pivotal trial.
Show & Tell: Beyond Clinical Evidence
Howell emphasizes that Cognito’s work in Alzheimer’s disease is not just about commercialization but a comprehensive partnership for holistic exploration. While the HOPE pivotal trial aims to showcase clinical effectiveness to meet FDA standards, Howell underscores the importance of cost-effectiveness and health economics to meet CMS requirements and achieve national coverage determination.
“In God we trust, and everyone else bring data,” Howell stated. “The evidentiary burden for drugs lies in the pre-market, and for devices, it’s in the post-market. Starting with robust premarket evidence generation is essential to shift that burden in the post-market.”
Rezai sees an opportunity to understand the community-level impact of earlier and more effective therapy starting in West Virginia, rather than in major metropolitan areas where innovation typically originates. “This is a significant opportunity to demonstrate how we can save money, reduce visits, help caregivers stay employed, and alleviate the emotional and financial burden associated with Alzheimer’s disease,” Rezai noted.
Is this the start of a value-based care model for Alzheimer’s? RNI’s system-level data on global costs will contribute to health economics and outcomes research to gain a better understanding of pricing strategies, patient and caregiver engagement, clinical education, and training, among other real-world priorities beyond reimbursement.
“I want to continue demonstrating the value of a neuroprotective environment in less advanced disease and potentially even in the absence of disease,” Howell expressed. “Ultimately, we aim to determine if this therapy should be considered for a broader population. Should we be proactively addressing brain health by enhancing plasticity and resilience?”
So Good It Hertz: Ripples and Roadmaps
Leaders from West Virginia University Rockefeller Neuroscience Institute and Cognito Therapeutics announced “The first Brain Health Collaboratory, a new model designed to accelerate the discovery, validation, and real-world delivery of non-drug neurotherapies.”
West Virginia University
This partnership holds implications for the neurotech field and US healthcare far beyond new headsets and dementia care models.
Towards More Neurotech Adoption
Improved treatments may lead to earlier patient intervention. While diagnosis remains challenging on a large scale, additional neurotechnologies have the potential to change the trajectory of how dementia impacts individuals, families, workplaces, and economies globally. Cognito already utilizes “confirmatory EEG testing” to identify the right patient cohort, as highlighted by Howell.
Rezai is a forward-thinking health system leader who embraces modern diagnostic and detection technologies to usher in a new approach to identifying and supporting patients earlier in their disease progression. He mentioned RNI’s use of analytics, optical coherence tomography, gait analysis, blood and genetic testing, and other technologies to comprehensively assess neurodegenerative conditions.
“We focus not only on Alzheimer’s but on various neurodegenerative conditions such as Parkinson’s, vascular dementia, Lewy body, and frontotemporal diseases,” Rezai explained. “It’s a spectrum of conditions that exhibit a range of manifestations, from motor to cognitive behavior. It’s about addressing brain diseases.”
RNI has also led groundbreaking work in focused ultrasound for Alzheimer’s and opioid addiction, as well as brain-computer interfaces with Precision Neuroscience. This Collaboratory model could integrate additional neurotechnologies in the future. Rezai emphasized the importance of industry partnerships in realizing substantive advancements at scale.
Pushing the Dialogue on Public Engagement
Howell has actively engaged with state-level leaders and congressional members to discuss Cognito’s work. Amid federal uncertainties, ensuring effective regulation and reimbursement remains a bipartisan priority, particularly in the realm of breakthrough medical devices. Howell highlighted the significance of conducting large-scale neurotech studies to establish a robust evidence base early on.
“There was a real acknowledgment of the need to ensure coverage and reimbursement for patients to access new treatments. If clinically validated, the senators expressed their willingness to escalate the issue to the Secretary,” Howell noted.
Looking beyond bridging the gap in research, the coming years present an opportunity to connect clinical innovation with federal initiatives at various agencies, fostering a national shift beyond traditional pharmaceutical treatments that have shown limited effectiveness in various medical disciplines.
The Potential of Health System Partnerships
Recent developments, such as Mass General’s launch of the nation’s first BCI clinic, highlight the potential for a unified model of care that spans specialties and technologies, from pre-diagnosis to ongoing care management. Such a model could benefit patients, families, and clinical teams while facilitating cost-effectiveness studies valuable to the industry in the future.
RNI and Cognito’s Collaboratory offers a replicable model for other health systems to follow, leveraging established clinical expertise, aligned incentives, visionary leadership, and emerging technologies. This initiative expands the horizon for driving generational advances through strategic philanthropy, venture capital, and public-private investments.
Earlier this month, Arena Bioworks announced an abrupt shutdown, underscoring the challenges of sustaining large-scale research projects without dedicated leadership and market uncertainties. In contrast, the focused research organization (FRO) model, with a focus on moonshot projects over five to seven years, shows promise in advancing scientific R&D.
Could a Collaboratory model, anchored by a visionary health system, provide FROs like Forest Neurotech or open-source innovators like Openwater with the ideal conditions to transform their innovations into sustainable and scalable research and treatment platforms?
Which Comes First: Care Model Or Foundation Model?
Every day, new startups are developing “foundation models” to explore the human brain using EEG data from wearables, implanted sensors, and other sources. BCI leaders like Synchron have formed partnerships to advance these models, signaling a growing trend in the industry.
With increasing excitement around AI’s potential to decode the human brain, Howell shared insights on how their Collaboratory has been leveraging advanced AI capabilities. “AI is integrated into everything we do,” Rezai emphasized, highlighting the significant investments in digital disease management infrastructure, longitudinal tracking, and comprehensive data analysis to enhance patient care and outcomes.
“The key is contextualizing the data and linking it to patient outcomes,” Rezai added. “Having a comprehensive ecosystem with experts from various disciplines working together is crucial for providing effective care and advancing research.”
Howell echoed this sentiment, noting the value of RNI’s proactive approach to understanding brain functionality beyond disease treatment. “The fact that all of this happens within the same ecosystem is incredibly valuable for a company like ours, as we aim to address not just the pathology of a disease but also enhance resilience,” Howell concluded.
