Neuroimaging to assess safety and efficacy of AD therapies.

During the last two decades, neuroimaging methods have become widely used to study the natural history of Alzheimer's disease and also as a means of assessing safety and efficacy of novel treatments. Widely used safety and efficacy end points are described, along with their level of maturity. The North American Alzheimer's Disease Neuroimaging Initiative (ADNI), and similar activities in Europe, Japan, and Australia, are natural history studies that are providing new insights into the use of imaging end points in clinical trials. While the results of these trials are not yet all available, a recipe for successful deployment of imaging to assess eligibility, safety and efficacy is emerging.