Imaging as a biomarker in drug discovery for Alzheimer's disease: is MRI a suitable technology?

Emilio Merlo Pich, Andreas Jeromin, Giovanni B Frisoni, Derek Hill, Andrew Lockhart, Mark E Schmidt, Martin R Turner, Stefania Mondello, William Z Potter
2014 Alzheimer's Research & Therapy  
This review provides perspectives on the utility of magnetic resonance imaging (MRI) as a neuroimaging approach in the development of novel treatments for Alzheimer's disease. These considerations were generated in a roundtable at a recent Wellcome Trust meeting that included experts from academia and industry. It was agreed that MRI, either structural or functional, could be used as a diagnostic, for assessing worsening of disease status, for monitoring vascular pathology, and for stratifying
more » ... linical trial populations. It was agreed also that MRI implementation is in its infancy, requiring more evidence of association with the disease states, test-retest data, better standardization across multiple clinical sites, and application in multimodal approaches which include other imaging technologies, such as positron emission tomography, electroencephalography, and magnetoencephalography. A practical question Developing a new drug is an evidence-based exercise. Collecting evidence relevant for decision-making to support the development of a novel chemical entity (NCE) requires investment in methodologies that are reliable, valid, and clinically relevant. In other words, we should answer the question: is it worthwhile to include a neuroimaging assessment in a clinical trial for a novel treatment in AD? If the method has regulatory approval, the inclusion in a clinical trial is generally supported. If not, the quality of the scientific data, the simplicity in execution, the
doi:10.1186/alzrt276 pmid:25484927 pmcid:PMC4255417 fatcat:oauvmaotwvbepcbsjzgwtiyxhi