MRI as a Surrogate Marker in Clinical Trials in Alzheimer’s Disease
The rapid development of novel treatment targets for Alzheimer's disease (AD) requires tools to assess the effects of these treatments on disease progression. Structural neuroimaging with CCT and magnetic resonance imaging (MRI) has been extensively applied in patients with AD over the last two decades. Today longitudinal MRI is integrated in the majority of clinical trials with novel compounds that aim at modifying the disease process. This makes MRI one of the major surrogate marker candidates in AD. A surrogate marker according to the definition of the regulatory agencies must correlate with the disease process and with drug-induced modifications of the disease. Beyond this, effects on the surrogate marker need to predict future clinical outcomes. Brain volume measures obtained from structural imaging studies in AD reflect the underlying pathology and correlate with clinical symptoms cross-sectionally and longitudinally. The effects of drugs on brain volume measures and the prediction of clinical outcomes by brain volume changes, however, are not yet sufficiently defined.
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