Functional Target Validation for Alzheimer's Disease-Related Dementias

The National Institute of Neurological Disorders and Stroke (NINDS) is interested in supporting ambitious research projects that propose comprehensive functional validation of newly identified therapeutic target candidates for Alzheimer’s Disease–Related Dementias (ADRD). A major barrier to the development of effective treatments for ADRD, as well as other complex central nervous system disorders, is the lack of well-validated targets that are clearly linked to disease mechanisms. Successful translation of basic discoveries into the clinic depends on the rigor of target validation and confidence in a causal relationship between modulation of a target and its functional physiological consequences relevant to treating or preventing disease. This initiative aims to de-risk subsequent translational research and accelerate the development of novel therapeutic strategies. NINDS believes that this initiative would be most appropriately supported by a phased award mechanism (for example, R61/R33). In the initial phase, support would be provided for the development of customized technologies, models, and protocols to modulate the expression or activity of candidate targets and to assess their physiological consequences in relevant in vitro and in vivo disease models. Upon successful achievement of predefined, milestone-based technical feasibility and proof-of-concept criteria, projects would transition to the second phase focused on measuring and cross-validating the effects of target modulation across multiple experimental modalities and collaborating laboratories, in accordance with NIH rigor and reproducibility guidelines. Applications are not being solicited at this time. Notice is being provided to allow potential applicants sufficient time to develop responsive projects and establish appropriate cross-disciplinary collaborations.

Other Eligible ApplicantsIndian/Native American Tribal Governments (Other than Federally Recognized);Eligible Agencies of the Federal Government;U.S. Territory or Possession;Faith-based or Community-based Organizations;Regional Organizations;Non-domestic (non-U.S.) Entities (Foreign Institutions) are not allowed

The major elements in evaluating proposals include assessments of: (1) the scientific merit and general significance of the proposed study and its objectives; (2) the technical adequacy of the experimental design and approach; (3) the competency of the proposed investigator or group to successfully pursue the project; (4) the adequacy of the available and proposed facilities and resources; (5) the necessity of the budget components requested in relation to the proposed project; and (6) the relevance and importance to announced program objectives. The following criteria will be used in considering the scientific and technical merit of SBIR/STTR Phase I grant applications: (1) the soundness and technical merit of the proposed approach; (2) the qualifications of the proposed principal investigator, supporting staff, and consultants; (3) the technological innovation of the proposed research; (4) the potential of the proposed research for commercial application; (5) the appropriateness of the budget requested; (6) the adequacy and suitability of the facilities and research environment; and (7) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or animal subjects, and/or (b) protecting against or minimizing any adverse effect on the environment. Phase II grant applications will be reviewed based upon the following criteria: (1) the degree to which the Phase I objectives were met and feasibility demonstrated; (2) the scientific...

This program has no statutory formula. Matching requirements are not applicable to this assistance listing. MOE requirements are not applicable to this assistance listing.

Not Applicable.