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Neurology supplements are not peer-reviewed. Information contained in Neurology supplements represent the opinions of the authors and are not endorsed by nor do they reflect the views of the American Academy of Neurology, Editor-in-Chief, or Associate Editors of Neurology.

Primary prevention trials in Alzheimer disease

From the Departments of Neurology and Medicine (Genetics Program), Boston University School of Medicine, and Department of Epidemiology, Boston University School of Public Health, Boston, Massachusetts (R.C.G.) and Department of Neurology and Alzheimer Disease Research Center, University of Pittsburgh, Pennsylvania (S.T.D.).

Address correspondence to Dr. Robert C. Green, Departments of Neurology, Genetics, and Epidemiology, Boston University School of Medicine, 715 Albany Street, L-320, Boston, MA 02118; e-mail: rcgreen{at}bu.edu

Many new treatments under development for Alzheimer disease (AD) will be disease-modifying rather than symptomatic. Clinical evaluation of these treatments will require primary and secondary prevention trials. We describe some of the methodologic challenges in designing primary prevention trials for AD and illustrate these with examples from the ADAPT (Alzheimer Disease Anti-Inflammatory Prevention Trial) Study and GEM (Ginkgo in Evaluation of Memory) Study. Primary prevention trials for AD present many design challenges. In most situations, secondary prevention trials provide the most feasible first step toward primary prevention.

Supported by NIH grants U01-AG15477 (the ADAPT Study), RO1-HG/AG02112 (The REVEAL Study), RO1-AG09029 (the MIRAGE Study), P30-AG13846 (Boston University Alzheimer Disease Core Center) and P50-AG01533 (University of Pittsburgh Alzheimer Disease Research Center.)

Publication of this supplement was supported by an educational grant from Beaufour Ipsen.

Disclosure: The sponsor has provided R.C.G. with an honorarium for his participation in this project. The sponsor has provided S.T.D. with an honorarium for his participation in this project and honoraria during his career.