Alzheimer's Clinical Trials Consortium (ACTC) Clinical Trials

The National Institute on Aging (NIA) intends to publish a Notice of Funding Opportunity (NOFO) to invite applications to develop and implement multi-site Phase Ib to III clinical trials of promising pharmacological and non-pharmacological interventions that may prevent, delay, or treat the symptoms of Alzheimer's disease (AD) and AD-related dementias (ADRD) using the Alzheimer's disease Clinical Trials Consortium (ACTC) trial coordination and management infrastructure. Working with the ACTC is a collaborative venture between the applicant, NIA, and the ACTC network. NIA and the ACTC leadership will provide guidance to potential applicants. The work of this NOFO will enable the testing of interventions that target deleterious cognitive and neuropsychiatric changes associated with age-related cognitive decline and AD/ADRD across the spectrum from pre-symptomatic to more severe stages of disease. Applications are not being solicited at this time. Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. This NOFO intends to utilize the R01 activity code. Investigators with expertise and insights into this area of aging research are encouraged to begin to consider applying for this NOFO.

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...

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.