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Renewal of the Development and Application of PET and SPECT Imaging Ligands as Biomarkers for Drug Discovery and for Pathophysiological Studies of CNS Disorders

NAMHC Concept Clearance

Presenter:

Enrique Michelotti, Ph.D.
Division of Neuroscience and Basic Behavioral Science

Goal:

The goal of this initiative is to encourage the development of novel radioligands for positron emission tomography (PET) or single photon emission computed tomography (SPECT) imaging to study the pathophysiology and treatment of brain disorders.

Rationale:

The use of radiotracers for imaging molecular events in preclinical and clinical studies is essential for understanding the circuitry that underlies normal brain function and the pathophysiology of brain disorders. Neuroimaging probes have broad potential application in pathophysiological studies, in evaluation of target engagement in drug discovery/development research, and for biomarker development/qualification studies as quantifiable indicators of disease progression and treatment efficacy. However, relatively few human radioligands are currently available for functional imaging of target molecules in brain. This initiative is intended to stimulate the development of radioligands for molecular targets in brain that are of broad interest to the scientific community. The widespread availability and use of these radioligands are expected to:  1) accelerate research on identifying and characterizing the neural circuits and pathways implicated in the pathophysiology of brain disorders (especially mental and behavioral disorders, substance abuse, neurodegenerative disorders, and pediatric brain disorders) and brain changes with age, and 2) facilitate the identification of new therapeutic targets and the development of new compounds as potential therapeutic agents.

Areas of interest include:

  • Lead compound identification, development, and syntheses of chemicals with suitable properties for radiochemical synthesis.
  • Pre-clinical studies of candidates for PET or SPECT imaging.
  • Determination of toxicology (FDA approved) for submission of an exploratory Investigational New Drug (IND) application or IND application.
  • Exploratory IND or IND application development and submission to the FDA prior to pilot human studies.
  • Pilot human imaging studies of the PET or SPECT radiotracer with normal controls or/and in patient/disease populations to assess its utility for research in pathophysiology, drug discovery, or biomarker development.