Alzheimer's Disease Drug Development Program (U01)

-Purpose. The objective of this solicitation is to stimulate research in the pre-clinical development and testing of novel therapeutic compounds aimed at slowing, halting, or reversing the progressive decline in cognitive function and modifying the behavioral symptoms in Alzheimer's disease (AD); or delaying the onset of or preventing AD, mild cognitive impairment (MCI), or age-related cognitive decline. This initiative is intended to stimulate activities focused on providing sufficient data to submit an Investigational New Drug (IND) application to the Food and Drug Administration to begin human clinical testing of potential new therapies. For this program neither mechanistic/basic studies nor clinical trials will be supported; only applications to develop a therapy will be accepted. -Mechanism of Support. This FOA uses the NIH U01 mechanism -Funds Available and Anticipated Number of Awards. NIA has set aside $2.5 M in total costs in FY2009 for applications submitted in response to this program announcement. However, because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. The total amount awarded and the number of awards will depend upon the number, quality, duration, and costs of the applications received.