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

The Alzheimer's Drug-Development Program (U01 Clinical Trial Optional), opportunity number RFA-AG-28-009, is a forecasted federal cooperative agreement opportunity from the U.S. Department of Health and Human Services through the National Institutes of Health and the National Institute on Aging. The opportunity is associated with Assistance Listing 93.866, Aging Research, and is categorized under Health. The National Institute on Aging intends to publish a Notice of Funding Opportunity to continue the Alzheimer's Drug-Development Program. Applications are not currently being solicited under this forecast; the advance notice is intended to give potential applicants sufficient time to establish meaningful collaborations and develop responsive projects. The planned opportunity will solicit applications proposing pre-clinical and early-stage clinical Phase I development of novel small-molecule and biologic drug candidates for Alzheimer's disease. Proposed candidates are expected to aim to prevent Alzheimer's disease, slow disease progression, or treat cognitive and behavioral symptoms. The program is intended to catalyze Alzheimer's disease drug development by supporting academic and biotechnology researchers undertaking preclinical drug development activities in their own laboratories or in collaboration with contract research organizations specializing in preclinical drug development. The program seeks to support challenging and costly drug-development steps while connecting preclinical development with first-in-human testing. Its stated objectives include expanding the number of investigational new drug candidates across a portfolio of emerging therapeutic targets, expanding the Alzheimer's disease therapeutic pipeline with candidates addressing multiple underlying disease mechanisms, and supporting candidates that may be used as monotherapy or as part of combination therapy. The program also seeks to enable a precision medicine approach to Alzheimer's disease drug development. The forecast does not state specific award amounts, total program funding, number of awards, indirect cost limitations, subaward limitations, or a defined period of performance. Cost sharing or matching is expressly identified as not required. Eligible applicants encompass a broad range of organization types. The forecast identifies nonprofit organizations with and without 501(c)(3) status, private institutions of higher education, public and state controlled institutions of higher education, small businesses, other for-profit organizations, independent school districts, state governments, county governments, city or township governments, special district governments, public housing authorities and Indian housing authorities, federally recognized Native American tribal governments, and Native American tribal organizations other than federally recognized tribal governments. Additional eligible applicants include Indian or Native American tribal governments other than federally recognized governments, eligible agencies of the federal government, U.S. territories or possessions, faith-based or community-based organizations, and regional organizations. No state-specific geographic limitation is stated. The planned Notice of Funding Opportunity will use the U01 activity code and permits an optional clinical trial component as reflected in the opportunity title. Because this is a forecast, the source does not yet provide application forms, narrative questions, required uploads, review criteria, registration or portal instructions specific to submission, or other detailed application mechanics. It also does not identify a letter of intent, concept paper, pre-proposal, notice of intent, or other pre-application gating requirement. Potential applicants therefore have advance notice of the program's scientific direction but will need the published Notice of Funding Opportunity for final submission requirements and evaluation details. The forecast was issued on August 13, 2026 and was last updated on August 13, 2026. The estimated posting date is March 10, 2027, and the estimated application due date is June 18, 2027. The estimated award date is April 30, 2028, and the estimated project start date is April 30, 2028, for fiscal year 2028. No recurring schedule or future-cycle frequency is stated in the source. Scientific program questions may be directed to the NIA Scientific Program Contact by email at NIA-NOFO-Scientific@nih.gov. Because the opportunity remains forecasted, these dates and other program details are estimates pending publication of the full Notice of Funding Opportunity.

Use the forecast period to develop meaningful collaborations and a responsive project. Align the proposed drug-development work with the program's stated aims of expanding investigational new drug candidates and the Alzheimer's disease therapeutic pipeline, addressing emerging targets and multiple disease mechanisms, connecting preclinical development with first-in-human testing, and enabling precision medicine.