The Use, Standardization, and Interpretation of Brain Imaging Data in Clinical Trials of Neurodegenerative Disorders.

ABSTRACT: Imaging biomarkers play a wide-ranging role in clinical trials for neurological disorders. This includes selecting the appropriate trial participants, establishing target engagement and mechanism-related pharmacodynamic effect, monitoring safety, and providing evidence of disease modification. In the early stages of clinical drug development, evidence of target engagement and/or downstream pharmacodynamic effect-especially with a clear relationship to dose-can provide confidence that the therapeutic candidate should be advanced to larger and more expensive trials, and can inform the selection of the dose(s) to be further tested, i.e., to "de-risk" the drug development program. In these later-phase trials, evidence that the therapeutic candidate is altering disease-related biomarkers can pr

SUBMITTER: Schwarz AJ 

PROVIDER: S-EPMC8423963 | biostudies-literature | 2021 Apr

REPOSITORIES: biostudies-literature