Director: Merle G. Paule, Ph.D.
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 can potentially provide opportunities for improved assessments of risk and identification of helpful approaches. 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 associated research areas.
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 and 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. In addition, efforts to develop sensitive, high-throughput systems (methods for creating large amounts of data in a short period of time) for screening potential neurotoxicants are underway.
Other unique features of the Division’s research capabilities include the ability to:
- determine chemical concentrations and cellular-level interactions in target tissue
- determine changes in gene and protein expression associated with chemical exposures
- effect high-throughput, comprehensive cognitive or behavioral assessments
- 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
- develop novel histochemical tracers to aid in the evaluation of chemical-induced pathologies
Examples of Current Research
- The effects of developmental exposures to pediatric general anesthetics on subsequent complex brain function in rodent and nonhuman-primate models:
Various anesthesia protocols have been used in pediatric medicine for many decades without systematic assessment concerning drug exposure and possible effects on the nervous system. The Division will assess the effects on both the body and nervous systems of subjects exposed to several commonly used anesthetics.
- The efficacy and toxicity of a variety of potential anti-Alzheimer’s agents using mouse and rat models:
Several research projects are being conducted on Alzheimer’s disease within the Division. One project will specifically research methods to treat aspects of Alzheimer’s and determine if the methods are safe enough for use in a clinical setting.
- Utilization of state-of-the-art imaging capabilities to provide new insights into the events contributing to neurotoxicity and neuroprotection:
The Division is continually striving to advance innovative imaging technologies and methods. The use of MRI, PET, CT, or any combination of the three gives researchers unique insight into the onset and prevention of neurotoxicity. The Division is currently using imaging methods to assess the neurotoxicity of pediatric anesthetics.
- The ability of nanomaterials and other regulated products to affect the integrity of a variety of nervous system-related models including the blood-brain barrier in vitro and in vivo:
The study of nanomaterials is still in its infancy, so there is much to learn about their potential contribution to toxicity within the body. The Division is actively researching the effect of nanomaterials on the nervous system using studies conducted in cell culture and with whole animals.
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.