Affiliations: Department of Neurosciences, University of California, San Diego, La Jolla, CA, USA
Correspondence:
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Correspondence to: Michael S. Rafii, MD, PhD, Department of Neurosciences, University of California, San Diego, 9500 Gilman Dr., MC 0949, La Jolla, CA 92093, USA. Tel.: +1 858 246 1300; Fax: +1 858 246 1417; E-mail: mrafii@ucsd.edu.
Abstract: In 2013, the Food and Drug Administration released draft guidance on drug development for early-stage Alzheimer's disease (AD). This guidance builds on the understanding that AD is a progressive disease with symptoms appearing long after neurodegeneration has begun. Preclinical AD relies on the conceptual distinction made between the presence of AD pathological processes and clinically observable symptoms. With the advent of new biomarkers that allow for presymptomatic detection of AD pathology, there now exists an opportunity to design and conduct clinical trials of putative disease-modifying drugs in the earliest stages of the disease when they are thought to have the greatest chance of success. As such, there are four clinical trials planned or underway for the secondary prevention of AD.
