About FDA

Neurotoxicology

Director: Merle G. Paule, Ph.D.

NCTR Imaging Center

Introduction

The National Institute of Mental Health estimates that one in four American adults suffer from a diagnosable mental disorder in any given year and that one in three will experience some form of mental disorder during their lifetime. Fifty-million Americans have a permanent brain disability that limits their daily activities. The number of persons suffering from Alzheimer’s, Parkinson’s, and other brain diseases is increasing dramatically as our population ages.

Division Capability and Research Focus

The Division of Neurotoxicology focuses on increasing FDA’s understanding of the processes associated with neurotoxic outcomes—harmful effects associated with the brain and nervous system. This increased understanding may provide opportunities for improved risk assessments and identification of new approaches to diagnosis. The Division’s strategy has been to use a broad range of research approaches that capitalize on the expertise of personnel in diverse areas of neuroscience and other scientific disciplines.

The Division is continually expanding its capabilities in the area of imaging by adding both microPET (positron emission tomography) and MRI (magnetic resonance imaging) instruments along with trained personnel. These innovative imaging technologies give researchers a unique way to monitor brain and nervous-system activity with minimal discomfort to the study subject.

Magnetic Resonance Imaging Machine

Other unique features of the Division’s research capabilities include the ability to: 

  1. determine chemical concentrations and cellular-level interactions in target tissue
  2. determine changes in gene and protein expression associated with chemical exposures
  3. effect high-throughput, comprehensive cognitive or behavioral assessments
  4. employ multiple species including nonhuman primates, rodents, and, in some cases, humans, in the risk-assessment process to reduce the uncertainty associated with extrapolating findings across species
  5. develop novel histochemical tracers to aid in the evaluation of chemical-induced pathologies

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Examples of Ongoing Research Projects
  • The effects of adult exposures to general anesthetics on subsequent complex brain function in rodent and nonhuman primate models.
     
  • Expanding the utilization of in vitro models to include non-human primate neural stem cells, blood-brain barrier models, and the zebrafish developmental-neurotoxicity model to study prototypic neurotoxicants including general anesthetics.
     
  • The efficacy and toxicity of a variety of potential anti-Alzheimer’s agents using transgenic-mouse and rat models.
     
  • The development and use of novel histochemical tracers to monitor the health of important nervous-system structures in both fresh and fixed tissue: incorporation of Rare Earth Metals.
     
  • Utilization of state-of-the-art imaging capabilities to provide new insights into the events contributing to neurotoxicity and neuroprotection using markers of cell death and neuroinflammation.
     
  • Identification of MRI approaches to support regulatory science efforts by developing standards for using MRI/Magnetic Resonance Spectroscopy (MRS) signals to direct traditional neuropathological assessments: begin biomarker qualification process.
     
  • Examine the relationship between performance of the tasks that comprise the NCTR Operant Test Battery (OTB) and clinically-relevant psychological tests to further assess the translatability of the OTB: multisite studies.
     
  • Non-human primate behavioral pharmacology studies to support FDA’s Center for Tobacco Product studies on the ability of tobacco product constituents to engender and/or maintain addictive behaviors.
     

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The NCTR Annual Report provides information on the latest accomplishments and plans for the Division of Neurotoxicology as well as project and publication listings for NCTR.

 

Contact FDA

870-543-7000
National Center for Toxicological Research

Food and Drug Administration

3900 NCTR Road

Jefferson, AR 72079

Page Last Updated: 09/02/2016
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