Applications of imaging biomarkers in the early clinical development of central nervous system therapeutic agents.

The early clinical drug development process increasingly utilizes imaging biomarkers to provide key information in response to a sequential series of questions about potential therapeutic agents. We present several examples of how imaging can answer some of these questions pertaining to the central nervous system (CNS) during the early phases of development of drugs to treat diseases involving the CNS. We also present an overview of the challenges and the potential of using and further qualifying imaging biomarkers for clinical trials.