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