Novel Assays to Address Translational Gaps in Treatment Development (UG3/UH3 Clinical Trial Optional)

Funding Agency:
National Institutes of Health

The overall goal of this initiative is to identify neurophysiological measures as potential assays for treatment development research. The funding opportunity announcement (FOA) will support efforts to optimize and evaluate measures of neurophysiological processes that are disrupted within or across mental disorders in both healthy humans and in another species relevant to the therapeutic development pipeline. The initiative will support initial proof of concept studies aimed at identifying measures for potential development as preclinical assays for evaluating potential new drug and device therapies and their targets. Data will also reveal assay measures where the performance between preclinical animal species and humans is dissimilar, thus establishing a firm basis for limiting speculative extrapolations of preclinical animal findings to humans. The ultimate practical goal of this FOA is to improve the efficiency of the therapeutic development process by identifying coherence of measures and inconsistencies between the preclinical screening pipeline and clinical evaluation of new treatment candidates and thereby hasten the development of more effective treatments for mental disorders.

The objectives of the FOA will be accomplished by supporting partnerships among basic and translational neuroscientists who are committed to advancing the discovery of in vivo physiological measures as tools for target validation and therapeutic development. Groups will be tasked with developing and optimizing in vivo assays of brain processes in both animals and in healthy humans. Groups will evaluate assay performance across both species in response to specific chemical, physiological, or behavioral manipulations. In this way, projects will reveal the potential of specific assays to translate from animals to humans, suggesting assays for further development as tools in the treatment development pipeline.

Deadlines:

  • Letter of Intent Due Date(s): 30 days prior to application due date
  • Application Due Date(s): June 20, 2019, October 18, 2019, February 20, 2020, June 19, 2020, October 20, 2020, February 19,2021, June 21, 2021, October 20, 2021, February 21, 2022

PAR-19-214 Expiration Date February 22, 2022

Agency Website

Areas of Interest

This FOA will support the phased development of in vivo assays to address translational gaps in treatment development for mental disorders. Support will be provided for assay development efforts that propose quantitative measures to assess alterations in neurophysiology/circuit activity that contribute to or reflect clinically relevant domains of function (e.g., cognitive function, impulsivity, and motivation, etc.).

Proposed projects may include:

  • Development and testing of in vivo neurophysiological measures that tap into fundamental processes that are disrupted within or across mental disorders such as aspects of vigilance, neural plasticity, reward processing, or attentional mechanisms contributing to cognition and/or affect regulation, that can be objectively measured in both live animals and humans using brain imaging or neurophysiological measures such as spectral EEG or MEG to assess brain rhythms with different frequencies. Innovative measures are encouraged.
  • Development and testing of highly tractable behavioral paradigms as assays that may serve as proxies of neural circuit activity linked to a specific functional domain in both humans and animals. For example, the CNTRICS program identified constructs across six cognitive systems relevant to schizophrenia and selected tasks from cognitive neuroscience that measure the constructs http://cntrics.ucdavis.edu/index.shtml. Such studies should combine behavioral and physiological measures (for example, tracking changes in forebrain oscillations during performance). Since the goal is to build innovation and address translational gaps, the inclusion of behavioral paradigms that are already commonly used cross species (e.g., fear conditioning) must incorporate novel measures of underlying neuronal processes.

Funding Type

Grant

Eligibility

Faculty

Category

Medical
Medical - Basic Science
Medical - Clinical Science
Medical - Translational

External Deadline

October 18, 2019