Molecular Neuroimaging of the Dopamine Transporter (DAT) as a Patient Enrichment Biomarker for Clinical Trials for Early Parkinson Disease

Abstract

The Critical Path for Parkinson's (CPP) Imaging Biomarker and Modeling and Simulation working groups aimed to achieve qualification opinion by the European Medicines Agency's (EMA) Committee for Medical Products for Human Use (CHMP) for the use of baseline dopamine transporter (DAT) neuroimaging for patient selection in early Parkinson disease (PD) clinical trials. This manuscript describes the regulatory science strategy to achieve this goal. CPP is an international consortium of 3 Parkinson's charities and 9 pharmaceutical partners, coordinated by Critical Path Institute).

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