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CNS Imaging

Alzheimer’s Disease
Typically not diagnosed until considerable mental decline, Alzheimer’s Disease (AD) is a degenerative brain disorder and the most common form of dementia.

Still without a cure, researchers now focus primarily on early detection with the hope of developing treatments to slow disease progression and facilitate improved quality of life.

Recognizing the ongoing evolution of magnetic resonance imaging (MRI), positron emission tomography (PET), and single-photon emission computed tomography (SPECT) imaging in dementia-related clinical trials, CoreLab Partners has put in place a team of knowledgeable, scientific experts and advanced computer technology tools to ensure current and evolving image assessment needs are met.

Operational Excellence
Our team has a broad base of clinical trial and basic science expertise using a wide array of PET and SPECT radioligands for the detection, pathophysiologic analysis, and the followup treatment-response assessment of a wide spectrum of neurodegenerative disorders and other dementing illnesses. In addition to image interpretation and assessment, CoreLab Partners is available to help design and implement a clinical imaging trial that is most appropriate for your protocol.

At CoreLab Partners, we understand the importance automation plays in the design and conduct of Alzheimer’s trials. To this end, our validated workflow integrates advanced, regulatory-compliant technologies and the highest level of project rigor to drive automated processes enabling accurate, reliable, and reproducible analysis throughout a study.

Standardization and Quality Assurance
CoreLab Partners’ comprehensive medical image management processes include secure Internet transfer of image data and centralized image assessment in a rigorous, quality controlled environment. Additionally, proven processes are employed to minimize bias and variability, and optimize quality and standardized data. These processes include image facility qualification and training, continual image quality assessment, and advanced image analysis techniques.

Expertise
Current image analysis assessment techniques include qualitative and quantitative image evaluation using region of interest or voxel based methods for evaluation of regional cerebral blood flow (CBF), regional brain metabolism, and neuroreceptor function in mild cognitive impairment (MCI) as well as early and late stage dementia. CoreLab Partners also has strong experience in the qualitative and quantitative assessment of brain amyloid burden using C-11-PIB and a variety of F-18 labeled amyloid-avid imaging compounds for
eligibility and response to treatment assessments.

CoreLab Partners has legacy expertise in all major modalities and biomarkers utilized in the conduct
of AD drug development, including structural, functional, and molecular imaging.

Coronal, transverse, and sagittal volumetric SGR MR images; and corresponding PET images in a patient with AD and an age-matched control.

Sponsor Benefits

• Credible, comprehensive trial data
• Costs and time efficiencies for expedited go/no-go decisions
• Streamlined and accelerated workflow
• Higher quality endpoints

Service Features

• Full range of modalities
• Experienced neuroradiology and radiology reviewers and imaging project teams
• Phantom-based site qualification
• Comprehensive site training
• Flexible review methods
• Best in class, validated technologies that are continually enhanced
• 21 CFR Part 11 compliance

Innovation
CoreLab Partners continues to invest in the most advanced technological solutions for medical image assessment. In addition to expertise across all major modalities, our physicians employ novel, FDA-compliant, fully automated software to derive quantitative imaging measurements from MRI, PET, and SPECT data.

Furthermore, CoreLab Partners has licensed the use of NeuroQuant® — a fully-automated, scientifically-validated technology solution designed to quickly and accurately quantify brain structure volumetric data.

NeuroQuant is a breakthrough medical device that is seamlessly integrated with the CoreLab Partners validated workflow and site qualification capabilities, making quantitative MRI measurement a routine part of clinical drug development.

NeuroQuant Features

• Segmentation and regional volumetric quantification
• Automatic correction for image artifacts
• Atlas-based image registration
• High validity
• High reliability
• Sensitive hippocampal volumes

CoreLab Partners is committed to assisting sponsors in bringing disease-modifying therapies from discovery to market.