Alzheimer's Drug-Development Program (U01 Clinical Trial Optional)

The National Institute on Aging (NIA) intends to publish a Notice of Funding Opportunity (NOFO) to solicit applications that propose pre-clinical and early-stage clinical (Phase I) development of novel small-molecule and biologic drug candidates that aim to prevent Alzheimer's disease (AD), slow its progression, or treat its cognitive and behavioral symptoms. Through the NOFO, NIA is continuing the Alzheimer's Drug-Development Program (ADDP) with the aim of catalyzing drug development for AD. The ADDP is designed to provide funding support to academic and biotech researchers for preclinical drug development activities that can be conducted in their own laboratories or conducted in collaboration with contract research organizations that specialize in preclinical drug development activities. By supporting the most challenging and costly steps of drug development and seamlessly connecting preclinical drug development and first-in-human testing for drug candidates, the ADDP program seeks to: • Continue to expand the number of investigational new drug candidates for a portfolio of emerging therapeutic targets; • Continue to expand the therapeutic pipeline for AD with drug candidates targeting multiple underlying disease mechanisms that can be used as mono-therapy or as part of combination therapy; and • Enable a precision medicine approach to AD drug development. The NOFO will utilize the U01 activity code. Applications are not being solicited at this time. This notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.

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;

The major elements in evaluating proposals include assessments of: the scientific merit and general significance of the proposed study and its objectives; the technical adequacy of the experimental design and approach; the competency of the proposed investigator or group to successfully pursue the project; the adequacy of the available and proposed facilities and resources; the necessity of the budget components requested in relation to the proposed project; and 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; 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 and technical merit of the proposed...