Neurological disorders represent one of medicine's most complex therapeutic frontiers, affecting millions globally while remaining leading contributors to disability and mortality. These conditions have a severe impact on cognition, motor function, and overall quality of life. Even with existing therapeutic options, countless patients face relentless disease progression, mounting disabilities, and substantial gaps in available care.

Developing innovative neurological therapies requires specialized research capabilities beyond standard clinical trial execution. The DCRI Neurosciences team combines experienced clinicians with a robust operational infrastructure. Our deep understanding of neurological pathophysiology and track record in managing complex studies make us the ideal partner for addressing the challenges of neurological drug development and therapies.

Disease Area Expertise

Our team provides expertise across all areas of neurology, neurosurgery, and neuropsychology, with particular strength and experience in the following areas:

Breakthrough neurological therapies require research partners who understand both the scientific complexity and operational demands of this challenging field. The DCRI Neurosciences team specializes in transforming ambitious therapeutic concepts into innovative, effective, and reliable clinical programs through our unique blend of clinical insight and research excellence.

Our portfolio of innovation includes:

• First-in-class treatments: Leading the first-ever Phase II study for intracerebral hemorrhage (CATCH trial), demonstrating our ability to navigate high-risk, high-reward therapeutic areas with compelling unmet medical needs.
• Revolutionary EEG endpoints: Pioneering the use of EEG as a clinical endpoint in the TRENdS study, establishing standardized definitions and quality assurance processes that have become the foundation for larger global trials like RAISE I/II.
• Advanced stem cell therapies: Developing novel regulatory strategies for first-in-human stem cell interventions, including intracranial injections for Alzheimer's disease and chronic stroke recovery (GABA-ERON, PISCES studies respectively).
• Digital therapeutics: Achieving FDA clearance for EndeavorRx, the first prescription-only game-based digital therapeutic device approved to improve attention function in children with ADHD.
• Non-pharmacological interventions: Leading a large federally-funded platform (RECOVER-NEURO) to evaluate the use of non-pharmacological interventions, such as transcranial direct current stimulation, adaptive interactive cognitive training, and mindfulness training to mitigate brain fog and cognitive symptoms in patients suffering from long COVID.
• Biomarker-driven trials: Proving therapeutic effect among patients with validated Alzheimer's diagnosis using biomarkers in the Annovis buntanetap study, completed ahead of schedule with effective site identification and rapid enrollment.

In addition to leveraging the expertise of our practicing physicians and innovative data scientists, the DCRI offers full-service clinical research organization (CRO) operational capabilities and the unique advantages of being embedded within Duke University's world-class academic medical center infrastructure. With decades of specialized experience in executing complex clinical trials, we are able to reduce study startup timelines compared to traditional CROs. Our proactive operational approach helps us anticipate challenges and deliver effective solutions, ensuring that your trials stay on schedule and within budget.

Specialized Neurosciences Capabilities

Innovative Clinical Neurophysiology

• Deep expertise in the collection, review, and adjudication of electrophysiology
• Established methods for EEG measures and endpoints
• Standardized training for sites to ensure proper patient selection and interpretation
• Quality assurance processes that minimize variability across sites

Complex Endpoint Management

• Delivering measurable outcomes where outcomes are hard to define
• Integrating biomarkers and their science into trial designs
• Novel assessment tools beyond traditional scales
• Real-time collaboration between adjudicators and study teams

Regulatory Excellence

• First-in-class regulatory strategies for novel interventions
• De Novo premarket review pathway expertise for digital therapeutics
• Investigational new drug (IND) applications for complex biologics and stem cell therapies
• Pre-IND meetings and orphan drug designations

Site Network & Partners

Our trusted network spans over 1,100 research sites across the U.S., Canada, and globally, and includes academic and community-based centers. Through established CRO partnerships, we offer flexible options for conducting studies worldwide, with site selection tailored to specific disease areas and study requirements.

Duke University’s health system is just one of the many sites in our extensive global network. The DCRI Neurosciences team integrates the clinics, resources, and services of this robust ecosystem of expertise, including precision genomics, AI health, population health sciences, and health policy.

The DCRI Neurosciences faculty represents one of the most comprehensive and experienced teams in clinical neuroscience research. Our faculty serve as principal investigators, steering committee members, and key opinion leaders for major industry trials, bringing insider knowledge of regulatory pathways and clinical development strategies to every project. They are recognized leaders in the neuroscience community, serving on editorial boards of leading journals including the Journal of the American Medical Association, New England Journal of Medicine, Stroke, Annals of Neurology, and Clinical Trials.

Whether you're developing novel endpoints for complex neurological conditions or conducting a pivotal regulatory trial, we're ready to discuss how our unique combination of clinical expertise and operational excellence can drive your project forward.