IND-Enabling Preclinical Studies of [¹¹C]COU, a Trapped Metabolite PET Radiotracer for Monoamine Oxidase-B.

ABSTRACT: [¹¹C]COU is a trapped metabolite radiotracer for in vivo analysis of Monoamine Oxidase B activity using positron emission tomography (PET) imaging. [¹¹C]COU has the potential to quantify astrocytosis in the early stages of Alzheimer's disease, providing an earlier marker of disease than currently available for staging disease progression. Prior preclinical studies have demonstrated the efficacy of this radiotracer in preclinical imaging studies, warranting the translation for clinical evaluation. In this paper, we describe results of the requisite preclinical studies required to obtain approval for translation of [¹¹C]COU into first-in-human studies. Development and validation of a production method that conforms to the quality requirements described

SUBMITTER: Frazier M 

PROVIDER: S-EPMC12622565 | biostudies-literature | 2025 Nov

REPOSITORIES: biostudies-literature