De-risk CNS drug development with Perceptive Discovery, a leading Preclinical Imaging CRO delivering advanced preclinical imaging solutions to accelerate translational success.

Introduction

According to a major study published in The Lancet Neurology, more than 3 billion people globally are living with a neurological condition. Central nervous system (CNS) conditions affect the brain and spinal cord, and common conditions include multiple sclerosis, stroke, epilepsy, spinal cord injury, Parkinson’s disease, and Alzheimer’s disease. The unmet needs of people living with conditions affecting the central nervous system are extremely high, and despite decades of clinical research, many CNS conditions lack disease-modifying interventions. Lack of available treatments is particularly concern considering the often debilitating side effects and impact on quality of life for patients suffering from CNS conditions. This ongoing unmet need is driven by the high complexity of CNS disease biology and the complexities of the research required to investigate it. Central nervous system (CNS) drug development is difficult, with high failure rates, unpredictable translation of preclinical research findings, and multifaceted disease pathophysiology.

As the leading cause of overall disease burden in the world, CNS disorders demand more effective prevention, treatment, and rehabilitation strategies. The reality of CNS drug development, combined with the unmet needs of this patient population, highlights the importance of innovative clinical trial design, advanced imaging modalities, and partnering with a Preclinical Imaging CRO with enough expertise and experience to drive the translation of research findings through to real-world therapeutic intervention. Perceptive Discovery has over 15 years of experience as a Preclinical Imaging CRO, with global success stories across CNS drug development, and key expert committees for each subsection of clinical development. At Perceptive Discovery, we believe that translational imaging is key to advancing CNS pipelines with greater confidence.

Why is CNS research and development so complex?

The Central Nervous System is particularly challenging to understand, and researchers face several hurdles when it comes to innovating and commercialising safe and effective treatments. Research suggests that drugs intended to treat disorders of the central nervous system take over a year longer to develop, and are less than half as likely to obtain approval as other drug development areas.

Key considerations:

• While the naturally protective membrane known as the blood-brain barrier protects the nervous system from toxins and pathogens in the blood, it can also restrict drug delivery to this region, making it more difficult for researchers to design effective therapeutic interventions. Perceptive Discovery utilises imaging techniques such as PET and MRI to provide mechanistic insight, to track whether a therapeutic compound crosses the blood-brain barrier and reaches the intended target.
• CNS is an umbrella term for a wide variety of different diseases, the heterogeneity of which makes research particularly challenging. Each CNS disorder varies greatly in patient population, presentation, progression, and underlying biology, meaning broadly translational therapies are rare, and drug development requires highly individualised approaches. Perceptive Discovery provides disease-specific biomarkers, tailoring preclinical study design to individual CNS indications, to generate disease-specific but translational data.
• CNS research often requires subjective or behavioral endpoints, which can be influenced by both individual subjectivity and experience, and rater variability. Perceptive Discovery provides objective quantitative biomarkers that are less influenced by subjectivity. Imaging modalities such as PET and MRI provide valuable data on brain function, structure, and receptor engagement, strengthening the value of subjective research outcomes. 
• CNS research often requires longitudinal monitoring, repeated measurements over time in the same individual to track any change in brain structure, function, or behaviour. This can be challenging, due to high attrition rates, data quality concerns, and practice effects. Perceptive Discovery helps to offset some of the challenges of longitudinal CNS research, utilising same subject preclinical imaging with advanced modalities to reduce variability and improve data quality, providing quantitative biomarkers which minimize the impact of practice effects. 

Our functional and molecular imaging solutions are well-suited for non-invasive longitudinal studies, providing multiple readouts, including:

• Biodistribution
• Target engagement and occupancy
• Neuropharmacodynamics
• Neurotransmitter release
• Biological therapeutics pharmacokinetics
• Neuroinflammation
• Neuromodulator analysis

By providing translationally relevant data prior to first-in-human studies, Perceptive preclinical imaging reduces uncertainty in CNS drug development, helping to identify the most promising candidates for IND submission.

How Perceptive Discovery supports CNS drug development

For nearly 30 years, Perceptive has been at the forefront of neuroscience imaging solutions, developing and delivering cutting-edge services for over 650 preclinical, early-phase, and late-phase clinical studies across neuro-degenerative, neuro-oncology, neuro-psychiatric, and rare disease indications.

Perceptive has analyzed thousands of preclinical and clinical scans across CNS indications, including Alzheimer’s Disease, Parkinson’s Disease, Huntington’s Disease, Multiple Sclerosis, Neuro-oncology, and many more. Perceptive’s image analysis team leverages industry-leading validated and exploratory tools for neuro PET, SPECT, CT, and MRI analysis pipelines to support all study endpoints. 

You can rely on Perceptive to help you optimize CNS development outcomes by:

• • Coordinating worldwide multi-center imaging studies and managing radiotracer supply
  • Facilitating a seamless transition of treatment candidates from preclinical research to clinical development
  • Clinically aligned imaging protocols tailored to CNS indications
  • Experience with complex neurodegenerative, psychiatric, and pain models
  • Expertise in biomarker development, with the ability to customize imaging timelines to match disease onset and treatment windows
  • Delivering advanced quantitative analyses for PET and MRI data to support CNS trials, including Alzheimer’s Disease trials

• Effectively managing the individual and customized imaging components of Multiple Sclerosis trials

• Engaging key expert committee groups across specific CNS disorders, with integrated support from study design to imaging execution and data interpretation

Perceptive Discovery is a well established Preclinical Imaging CRO, fully equipped to support your CNS discovery trial, housing the translational science and expertise needed to drive therapeutic discovery. Perceptive support confidence in your lead small molecule candidate, advancing CNS research with smart preclinical trial decision making, ensuring you proceed to human studies with the most promising CNS drug candidate.

To see how we can drive your CNS drug development program, go to Perceptive Discovery Services today, or Contact a Discovery solutions specialist.

Resources

The Lancet Neurology. Global, regional, and national burden of disorders affecting the nervous system, 1990–2021: a systematic analysis for the Global Burden of Disease Study 2021. https://www.thelancet.com/journals/laneur/article/PIIS1474-4422(24)00038-3/fulltext 

Signal Transduction and Targeted Therapy. The blood–brain barrier: Structure, regulation and drug delivery. https://pmc.ncbi.nlm.nih.gov/articles/PMC10212980/