Imaging in Neuroscience Clinical Trials

Schedule a meeting with Perceptive CNS Scientists at AAIC

Neuroimaging services are a key element for understanding disease mechanisms, a primary data source for regulatory submissions and precision medicine strategies in neuroscience clinical trials. 

Introduction

As next-generation central nervous system (CNS) therapies advance to disease-modifying, precision medicine approaches, the need for sophisticated and yet harmonized services to support imaging in neuroscience clinical trials is vital. Neuroimaging services are becoming a strategic pillar of neuroscience clinical research, supporting not only diagnosis but also guiding study design, patient selection, and measuring treatment effects.

Whether you are evaluating Alzheimer’s Disease, Parkinson’s Disease, depression, or a rare neurodegenerative disease, choosing the right imaging partner can directly impact your ability to select the appropriate study endpoints, meet milestones, secure regulatory approvals, and bring life-changing therapies to patients who need them.

This article will consider why effective imaging matters in the context of neuroscience clinical trials, and Perceptive stands at the forefront of neuroscience imaging, delivering unparalleled value to sponsors in the development of next-generation CNS therapies.

Why imaging matters in neuroscience clinical trials

Conditions affecting the nervous system are collectively ranked as the leading cause of overall disease burden in the world, causing the most disability-adjusted life-years (DALYs), and involving around 3.4 billion individuals. The increasing social and economic burden associated with CNS diseases, including neurodegenerative diseases, highlights the pressing need to develop effective therapeutic options that delay disease progression and reduce morbidity.

Achieving this requires precise, well-integrated, and reliable evaluation tools.

Imaging has become an essential tool for understanding the central nervous system and potential therapeutics. CNS drug development is becoming increasingly dependent on imaging biomarkers to generate evidence that is both clinically meaningful and robust. Imaging techniques such as MRI, PET, and SPECT provide valuable insights into brain function, target engagement, and disease progression.

No longer just a tool for monitoring clinical status, imaging supports:

• Early diagnosis
• Patient stratification
• Confirmation of target engagement
• Therapeutic monitoring
• Dose optimization
• Adverse event detection
• Regulatory support

Why Perceptive is a market leader for imaging in neuroscience clinical trials

The preferred CNS trial imaging partner for industry leaders, Perceptive has widespread experience across CNS indications, including extensive experience in different visual read criteria and quantitative analyses across multiple modalities. Perceptive has worked at the forefront with leaders in CNS, as well as companies new to CNS, advancing breakthrough therapies.

Experts in combining advanced analytics with visual reads

At Perceptive Imaging, we bring together the power of quantitative image analysis and the clinical insight of expert visual reads to deliver deeper, more actionable data.

• Market leader in CNS Imaging, including 18 regulatory approvals
• Global imaging network of over 2,000 qualified imaging centers
• Fully validated quantitative image analysis pipelines
• Longevity and experience of the neuro reader pool: >15,000 amyloid reads each
• >70,000 Quantitative PET and MR Analyses in 7 years
• Develops and deploys new algorithms and visual read 

Leaders in Imaging for CNS Trials

We are market leaders in radioligand development, with deep experience in PET-based CNS biomarkers and quantitative imaging endpoints critical for radioligand therapies.

• Over 750 neuro trials supported
• Supported all major Alzheimer’s Disease trials over the last decade, including 18 FDA approvals
• Leader in tracer development and validation
• Sole core lab on PPMI and close relationship with MJFF

2000 PET/SPECT/MRI imaging centers, qualified globally

With our worldwide network of qualified imaging centers equipped with CNS-specific modalities, we can ensure standardized protocols and reproducible data at scale.

• Global infrastructure and scalability, end-to-end support
• Deep experience in PET-based CNS endpoints 
• Experts in complex setups – Sites will be set up and trained on time
• Library of phantoms
• Training programs and systems to minimize queries and harmonize data

Supporting key CNS approvals

Our rapid scale-up of neuroscience imaging services for a Phase 3 Alzheimer’s clinical trial resulted in a novel compound being granted FDA approval for the treatment of early symptomatic Alzheimer’s Disease. Perceptive imaging data demonstrated the compound’s effectiveness at reducing amyloid plaques and significantly slowing clinical decline among study participants.

Key Highlights:

• Over 390 sites onboarded in < 3 months
• 6,900 eligibility scans reviewed over 7 months
• Average 100 scans/day at peak
• Query response TAT = ~1 day
• Eligibility scan reviews TAT = ~2-4 days
• 1,736 enrolled subjects
• 30-month trial
• 9,000 Amyloid PET scans and ~4,500 Tau PET scans reviewed

Perceptive Imaging’s CNS group understands the unique and custom requirements of neuroscience clinical trials and has the flexibility, creativity, bandwidth, and understanding in place to effectively manage and support CNS therapy development.

Accelerate your trial, optimize your data, and support confident regulatory decisions. Reach out today, and one of our solution experts will be in touch to learn about your specific trial needs.