Center without Walls for PET Ligand Development for Alzheimer's disease-related dementias (ADRDs) (U19 - Clinical Trial Optional) | RFA NS 24 011

Opportunity Information: Apply for RFA NS 24 011

The NIH funding opportunity RFA-NS-24-011 supports the creation of a "Center without Walls" dedicated to developing PET radioligands for Alzheimer’s disease-related dementias (ADRDs). The basic goal is to speed up the discovery and early clinical translation of imaging agents that can detect ADRD-relevant proteinopathies or other disease processes in humans. Rather than funding a single lab or a single target, the FOA is structured to support a coordinated, multi-project center that can take promising ligands from early evaluation through optimization and into first-in-human PET studies. It is tied to the ADRD research challenges identified in the 2016 update to the National Plan to Address Alzheimer’s Disease, emphasizing tools that can clarify human biology and enable better diagnosis, stratification, and therapeutic development.

The scientific scope spans the pipeline required to produce usable PET tracers, including in vitro screening of existing ligands using human ADRD brain tissue, medicinal chemistry work to design new compounds or refine older ones, early in vivo testing in appropriate animal models, and the practical steps needed to prepare and evaluate a PET radioligand for human use. In other words, the FOA is not limited to chemistry or imaging alone; it explicitly supports the end-to-end workflow that moves candidates from bench screening to clinical readiness. Projects are expected to generate evidence that a ligand is specific and selective for relevant pathology, behaves properly in living systems, can be radiolabeled and formulated reliably, and is suitable for initial human studies.

A defining feature is the required center structure. Applications must include an administrative core to coordinate the program, a medicinal chemistry core to drive compound design and optimization, and a clinical core to support radioligand production readiness and first-in-human evaluation. In addition, a formal scientific governance structure is required, reflecting that this is a cooperative, team-science program intended to operate across sites and disciplines. The FOA also requires at least two research projects, each with milestone plans. Those milestones must lay out workable screening and decision workflows for evaluating both existing ligands and newly developed candidates against human ADRD tissue and appropriate animal models. The expectation is that the center is more than a collection of independent projects; there needs to be clear synergy among the projects and cores, such that the overall aims would not be realistically achievable without the shared center framework, infrastructure, and coordinated decision-making.

The award mechanism is a U19 cooperative agreement (clinical trial optional), meaning NIH will likely have substantial programmatic involvement compared with a standard research grant. The activity category is health, and the listed CFDA numbers are 93.853 and 93.866. The opportunity sits under the NIH (National Institutes of Health). The posted award ceiling is $3,750,000, and the original closing date was 2023-10-04 (so the specific round described is time-bound, though similar opportunities may recur). The emphasis on milestones and coordinated workflows fits the cooperative agreement model, where progress toward predefined development steps is central.

Eligibility is broad across U.S.-based organizations and can include state, county, and local governments; public and private institutions of higher education; federally recognized tribal governments; tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations (other than small businesses); and small businesses, among others. The FOA also highlights inclusivity of a wide range of institution types such as HBCUs, Hispanic-serving institutions, AANAPISIs, TCCUs, Alaska Native and Native Hawaiian serving institutions, faith-based or community-based organizations, regional organizations, and U.S. territories or possessions. At the same time, non-U.S. (foreign) organizations and foreign institutions are not eligible to apply, and non-U.S. components of U.S. organizations are not eligible. However, foreign components as defined by the NIH Grants Policy Statement are allowed, which typically means certain defined collaborations or elements may be conducted abroad under NIH rules even though the applicant organization must be eligible and U.S.-based.

Overall, this FOA is designed to build a tightly integrated, multi-disciplinary program that can repeatedly generate, test, optimize, and translate PET ligands for ADRD biology, with a clear emphasis on human tissue validation, rigorous selection criteria, and practical readiness for first-in-human PET imaging. The center model and required cores are intended to reduce fragmentation in ligand development and create an efficient, shared pipeline that can move candidates forward faster than separate, stand-alone projects could.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Center without Walls for PET Ligand Development for Alzheimer's disease-related dementias (ADRDs) (U19 - Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.853, 93.866.
• This funding opportunity was created on 2023-05-03.
• Applicants must submit their applications by 2023-10-04. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $3,750,000.00 in funding.
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for RFA NS 24 011

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