Quantitative brain imaging biomarkers now play a central role in clinical trials for AD, as they may permit a more direct assessment of the effects of a therapy on brain function, amyloid load, and rate of neurodegeneration. Such information complements clinical and cognitive data points to provide a more complete picture of an intervention's putative disease-modifying effects. Further, clinical brain imaging and central clinical overread may be required for monitoring patient safety during a trial. However, the complexity of imaging data requires ready access to specialized neuroimaging expertise to assist in developing and maintaining state-of-the-art approaches in study design as well as data management, analysis, and sharing. No single institution houses such a wide array of expertise, and the rapid evolution of the field calls for an organizational structure that allows project leaders flexibility in selecting best available design and analysis approaches, while maintaining consistency through centralized data upload and management.
The overarching objective of the imaging core is to provide the infrastructure necessary for collection, management, and analysis of PET and MRI biomarkers in ADCS clinical trials and assist in widely sharing these data upon trial completion.
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