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Ethical considerations are intrinsic to the responsible conduct of neuroscience research and the translation of neuroscience advances (scientific and technological) into practice. This Notice of Special Interest (NOSI) highlights interest in receiving grant applications to advance research on ethical questions relevant to the NINDS mission of pursuing important work to gain a deeper understanding of the brain and nervous system to develop effective therapies for all people.

This Notice of Funding Opportunity (NOFO), issued by the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA), invites eligible United States small businesses to submit Small Business Innovation Research (SBIR) grant applications. United States small businesses that have the research capabilities and technological expertise to contribute to the R and D mission(s) of the NIH, CDC, and FDA awarding components identified in this NOFO are encouraged to submit SBIR grant applications in response to identified topics (see SBIR/STTR Program Descriptions and Research Topics for NIH, CDC, and FDA). This Parent Funding Opportunity Announcement does not accept clinical trials.

Many avenues of research are focused on improving our understanding of Lewy body dementia (LBD), including the disease's underlying biology and genetic risk factors. Environmental risk factors are also considered but are understudied. This Notice of Funding Opportunity (NOFO) is to support research that establishes causal links between a range of environmental factors and Lewy body formation.  These factors include exposures to environmental toxicants, light and noise, climate, and other external exposures.  This NOFO will support mechanistic, translational, and human subject studies to understand the relationship between environmental factors and LBD. It is expected that these studies will identify environmental risk factors related to the cause of LBD and its progression and their clinical relevance. Ultimately, these studies on LBD should accelerate mechanism-focused research to identify relevant pathways with potential to lead towards better and novel therapeutic interventions and quality of life. 

The purpose of the NINDS Alzheimers Disease and Alzheimers Disease-Related Dementias (AD/ADRD) Advanced Postdoctoral Career Transition Award to Promote Diversity (K99/R00) program is to support of a cohort of new and talented, independent investigators from diverse backgrounds conducting AD/ADRD research. The program is designed to facilitate a timely transition of promising postdoctoral researchers from diverse backgrounds (e.g., see NIHs Interest in Diversity) from their mentored, postdoctoral research positions to independent, tenure-track or equivalent faculty positions. The program will provide independent NIH research support during this transition in order to help awardees establish independent research programs in the AD/ADRD field.This FOA is designed specifically for applicants proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary study to a clinical trial. Applicants to this FOA are permitted to propose research experience in a clinical trial led by a mentor or co-mentor.

The purpose of the NINDS Alzheimers Disease and Alzheimers Disease-Related Dementias (AD/ADRD) Advanced Postdoctoral Career Transition Award to Promote Diversity (K99/R00) program is to support of a cohort of new and talented, independent investigators from diverse backgrounds conducting AD/ADRD research. The program is designed to facilitate a timely transition of promising postdoctoral researchers from diverse backgrounds (e.g., see NIHs Interest in Diversity) from their mentored, postdoctoral research positions to independent, tenure-track or equivalent faculty positions. The program will provide independent NIH research support during this transition in order to help awardees establish independent research programs in the AD/ADRD field.This FOA is designed specifically for applicants proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary study to a clinical trial. Applicants to this FOA are permitted to propose research experience in a clinical trial led by a mentor or co-mentor.

(Reissue of PAR-18-665) This Funding Opportunity Announcement (FOA) encourages Small Business Innovation Research (SBIR) applications from small business concerns (SBCs) that seek additional funding to support clinical trials for projects that were previously funded by NIH SBIR and STTR Phase II awards. The projects must focus on products related to the mission and goals of the National Institute of Neurological Disorders and Stroke (NINDS) and may evaluate drugs, biologics, devices, or diagnostics, as well as surgical, behavioral or rehabilitation therapies. Since conducting the clinical trials needed for commercialization may be capital-intensive, the FOA aims to facilitate the transition of SBIR Phase II projects to the commercialization stage by promoting partnerships between NIH's SBIR/STTR awardees and third-party investors and/or strategic partners. Consistent with the goals of this funding initiative and as required by the SF424 instructions for all SBIR Phase II applications, applicants must submit a Commercialization Plan, which should include details on any independent third-party investor funding that has already been secured or is anticipated during the project period. It is expected that the level of this independent third-party funding will equal or exceed the NINDS funds being requested throughout the SBIR Phase IIB project period.

Applications to this NOFO will propose research to establish clinical trial readiness for community-driven interventions to understand and develop solutions addressing barriers to equity in ADRD outcomes among populations defined by the NIH to experience health disparities and communities that intersect with them. Applications should consider the social, ethical, and behavioral implications (SEBI) related to assessing risk for, identification of, or treatment of ADRD among underserved and marginalized populations and how these factors may relate to existing or potential barriers to achieving equity and impact future clinical trials.

This NOFO invites applications that propose the comprehensive functional validation of newly identified therapeutic target candidates for Alzheimer's Disease-Related Dementias (ADRDs). This NOFO seeks to promote critical target validation approaches to help de-risk subsequent translational research and accelerate the advancement of novel therapies for ADRD. Target(s) or molecular pathway(s) to be considered for validation must have been already identified using tissue expression or genetic data generated in human samples. In its initial phase, this FOA provided support for up to two years (R61 stage) for the development of customized technologies, models, and protocols to modulate the expression or activity of target candidate(s) in cells or tissues and monitor their functional biological consequences in in vitro or in vivo disease models. Upon demonstration of technical feasibilities, a second phase (R33 stage) will carefully and reproducibly measure and cross-validate the impact of the target modulation in different modalities across collaborating laboratories using the NIH rigor and reproducibility guidelines. Applicants responding to this NOFO must address objectives for both the R61 and R33 phases and are expected to have a substantial collaborative effort between independents laboratories. This NOFO is not specific for any one or group within the ADRD spectrum of disorders. Disorders covered in these applications are frontotemporal degeneration (FTD), Lewy body dementias (LBD) (including dementia with Lewy bodies (DLB)), Parkinson disease dementia (PDD), vascular contributions to cognitive impairment and dementia (VCID), mixed dementias including the associated diagnostic challenges of multiples etiology dementias (MED).

This RFA is soliciting applications proposing placebo-controlled, clinical trials to determine the efficacy and safety of FDA approved monoclonal antibody therapies directed against amyloid compared to placebo in diverse "mixed dementia" populations with a focus on Lewy Body Dementias (LBD). In this NOFO the mixed-etiology dementias (MED) that are of interest and that are in scope are cognitive impairment and dementia cases positive for 1) canonical Alzheimers pathology biomarkers (for example, amyloid deposition assessed using positron emission tomography and/or low cerebrospinal fluid amyloid beta 42 combined with elevated phosphorylated tau; and 2) a clinical LBD diagnosis, i.e. Parkinsons disease dementia (PDD) and/or dementia with Lewy bodies (DLB). Bayesian approaches with response adaptive randomization to examine specific subgroups are encouraged. Successful applications will be powered to determine efficacy in diverse populations representative of the distribution of the disease in the United States by sex, race/ethnicity, and geographic distribution. Applications must include elements of patient and community engagement that are incorporated into all stages of program development and at all levels of the organizational structure.

The purpose of the NIH Independent Scientist Award (K02) is to foster the development of outstanding scientists and enable them to expand their potential to make significant contributions to their field of research. The K02 award provides three to five years of salary support and "protected time" for newly independent scientists who can demonstrate the need for a period of intensive research focus as a means of enhancing their research careers. Each independent scientist career award program must be tailored to meet the individual needs of the candidate.This Parent Funding Opportunity Announcement is for basic science experimental studies involving humans, referred to in NOT-OD-18-212 as prospective basic science studies involving human participants. These studies fall within the NIH definition of a clinical trial and also meet the definition of basic research. Types of studies that should be submitted under this FOA include studies that prospectively assign human participants to conditions (i.e., experimentally manipulate independent variables) and that assess biomedical or behavioral outcomes in humans for the purpose of understanding the fundamental aspects of phenomena without specific application towards processes or products in mind. Applicants not planning an independent clinical trial or basic experimental study with humans, or proposing to gain research experience in a clinical trial or basic experimental study with humans led by another investigator, must apply to the 'Independent Clinical Trial Not Allowed' companion FOA. The proposed project must be related to the programmatic interests of one or more of the participating NIH Institutes and Centers (ICs) based on their scientific missions.