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Funding Opportunities
Prodromal α-Synucleinopathies Consortium (PαSS) (U19 Clinical Trial Optional)
Funding Opportunity Purpose
This funding opportunity announcement (FOA) invites applications to develop a multisite, longitudinal, prospective study of idiopathic REM sleep behavior disorder (iRBD) as a prodromal phase of α-synuclein neurodegenerative disorders.
Accelerating Medicine Partnership in Parkinson’s disease (AMP PD) data use and analysis (U01 Clinical trials not allowed)
Funding Opportunity Purpose
The purpose of the funding opportunity announcement (FOA) is to support the use and analysis of data available through the knowledge portal for the Accelerating Medicine Partnership in Parkinson’s disease (AMP PD). This FOA invites applications that will utilize AMP PD data within the AMP PD Google cloud environment to apply computational approaches that will enable data integration and analysis across AMP PD clinical, genomic and transcriptional datasets to identify algorithms, biomarkers and biological pathways related to Parkinson’s disease diagnosis, prognosis and progression. Datasets outside of AMP PD may be brought into the AMP PD cloud environment to further the analysis and validation of discoveries originating from the use of AMP PD data. Computational approaches will be developed and managed through the application of Jupyter notebooks in the AMP PD cloud environment. Workflows and tools developed through this research will be deposited in the AMP PD methods repository for broad sharing with the research community.
Peripheral Pathology in the Lewy Body Dementias (R01 Clinical Trial Not Allowed)
Funding Opportunity Purpose
The purpose of this initiative is to identify potential diagnostic markers for the Lewy Body Dementias using non-blood or non-CSF peripheral specimens and tissues (e.g., skin, salivary gland, gastrointestinal tract, etc.). Blood and CSF have traditionally and extensively been examined for neurodegenerative disease biomarkers; however, research suggests that abnormal alpha-synuclein accumulation occurs in other peripheral tissues and specimens early in the disease course and may provide opportunities for early diagnosis and future treatment development.
Discovery of Biomarkers and Biomarker Signatures for Neurological and Neuromuscular Disorders (R61/R33)
Funding Opportunity Purpose
The overarching purpose of this Funding Opportunity Announcement (FOA) is to promote the discovery of strong candidate biomarkers and biomarker signatures for neurological and neuromuscular disorders/diseases that can be used as tools to facilitate the clinical development of neurotherapeutics and their use in clinical practice. Specifically, the focus of this FOA is on the identification and initial biological, analytical and clinical evaluation of biomarkers and biomarker signatures for neurological or neuromuscular disorders/diseases. Although research supported by this FOA can include animal studies, it must also include preliminary evaluation of the biomarker or biomarker signature in carefully standardized human samples or datasets. The goal of this initiative is to deliver candidate biomarkers and biomarker signatures that are ready for definitive analytical and clinical validation studies (see PAR-18-548, PAR-18-549, PAR-18-550 , PAR-19-220 and PAR-18-664).
Analytical Validation of a Candidate Biomarker for Neurological Disease (U01)
Funding Opportunity Purpose
The overarching purpose of this Funding Opportunity Announcement (FOA) is to fill critical scientific gaps needed to advance strong candidate biomarkers of neurological disease from discovery to clinical use. Specifically, the focus of this FOA is on the validation of analytical methods for biomarker measurements, including evaluation of the assay, its performance characteristics, and the optimal conditions that will generate reproducibility and accuracy consistent with FDA guidelines that are fit for the purpose of the assay.
Analytical Validation of a Candidate Biomarker for Neurological Disease (U44)
Funding Opportunity Purpose
The overarching purpose of this Funding Opportunity Announcement (FOA) is to fill critical scientific gaps needed to advance strong candidate biomarkers of neurological disease from discovery to clinical use. Specifically, the focus of this FOA is on the validation of analytical methods for biomarker measurements, including evaluation of the assay, its performance characteristics, and the optimal conditions that will generate reproducibility and accuracy consistent with FDA guidelines that are fit for the purpose of the assay.
Clinical Validation of a Candidate Biomarker for Neurological Disease (U01)
Funding Opportunity Purpose
The overarching purpose of this Funding Opportunity Announcement (FOA) is to fill critical scientific gaps needed to advance strong candidate biomarkers from discovery to clinical use. Specifically, the focus of this FOA is to support the clinical validation of candidate biomarkers of neurological disease using retrospective and/or prospective methods. Research supported by this FOA should demonstrate that biomarker change is reliably correlated with variables such as clinical outcome, disease progression, disease onset and severity, drug target engagement or response to a drug. In addition, biomarker response should be specific to the disease or therapeutic as demonstrated at multiple clinical sites.
Clinical Validation of a Candidate Biomarker for Neurological Disease (U44)
Funding Opportunity Purpose
The overarching purpose of this Funding Opportunity Announcement (FOA) is to fill critical scientific gaps needed to advance strong candidate biomarkers from discovery to clinical use. Specifically, the focus of this FOA is to support the clinical validation of candidate biomarkers of neurological disease using retrospective and/or prospective methods. Research supported by this FOA should demonstrate that biomarker change is reliably correlated with variables such as clinical outcome, disease progression, disease onset and severity, drug target engagement or response to a drug. In addition, biomarker response should be specific to the disease or therapeutic as demonstrated at multiple clinical sites.
NINDS Exploratory Clinical Trials (U01 Clinical Trial Required)
Funding Opportunity Purpose
The purpose of this Funding Opportunity Announcement (FOA) is to encourage grant applications for investigator-initiated exploratory clinical trials to the National Institute of Neurological Disorders and Stroke (NINDS). The trials must address questions within the mission and research interests of the NINDS and may include Phase 1 and 2 studies of drugs and biologics, feasibility studies of devices, and early studies of surgical, behavioral or rehabilitation therapies. All exploratory trials must contribute to the justification for, and provide some of the data required to inform a future trial to establish efficacy (such as a Phase 3, Phase 4 or Pivotal trial).
NINDS Efficacy Clinical Trials (U01 Clinical Trial Required)
Funding Opportunity Purpose
The purpose of this Funding Opportunity Announcement (FOA) is to encourage grant applications for investigator-initiated clinical trials to the National Institute of Neurological Disorders and Stroke (NINDS) to establish the efficacy (or compare the effectiveness) of treatment interventions. These Phase 3, Phase 4 or Pivotal trials must address questions within the mission and research interests of the NINDS and may include studies of drugs, biologics, and devices, as well as surgical, behavioral or rehabilitation therapies.
Dissemination and Implementation Research in Health (R01, R21, R03)
Funding Opportunity Purpose
The purpose of this Funding Opportunity Announcement (FOA) is to support innovative approaches to identifying, understanding, and developing strategies for overcoming barriers to the adoption, adaptation, integration, scale-up and sustainability of evidence-based interventions, tools, policies, and guidelines. Conversely, there is a benefit in understanding circumstances that create a need to stop or reduce (“de-implement”) the use of interventions that are ineffective, unproven, low-value, or harmful. In addition, studies to advance dissemination and implementation research methods and measures are encouraged.
All applications must be within the scope of the mission of one of the Institutes/Centers listed above.
Companion Funding Opportunity:
PAR-19-275, R21 Exploratory/Developmental Grant
PAR-19-276, R03 Small Grant Program
Contact: Peter.Gilbert@nih.gov
Clinical Trial Readiness for Rare Neurological and Neuromuscular Diseases (U01)
Funding Opportunity Purpose
This Funding Opportunity Announcement (FOA) invites researchers to submit applications for support of clinical studies that address critical needs for clinical trial readiness in rare neurological and neuromuscular diseases. These studies should result in clinically validated biomarkers and clinical outcome assessment measures appropriate for use in upcoming clinical trials. Through the support of trial readiness studies, NINDS and NCATS expect to enhance the quality and increase the likelihood of success of clinical trials in these rare diseases.
Comparative Effectiveness Research in Clinical Neurosciences (UG3/UH3)
Funding Opportunity Purpose
The purpose of this Funding Opportunity Announcement (FOA) is to encourage grant applications for investigator-initiated prospective observational comparative effectiveness research (CER) to the National Institute of Neurological Disorders and Stroke (NINDS) (note: only prospective observational studies will be considered)). The study must address questions within the mission and research interests of the NINDS and may evaluate preventive strategies, diagnostic approaches, or interventions including drugs, biologics, and devices, or surgical, behavioral, and rehabilitation therapies. NINDS is particularly interested in pragmatic study designs that utilize a cost-effective means of prospectively collecting observational data important to current clinical practice.
Biomarkers Discovery In Parkinsonism (U01 Clinical Trial Optional)
Funding Opportunity Purpose
The purpose of this funding opportunity announcement (FOA) is to support hypothesis-driven research to discover human biomarkers in Parkinson’s disease and other Parkinsonian syndromes, as a component of the NINDS Parkinson’s Disease Biomarkers Program (PDBP). This FOA encourages biomarkers discovery projects in: 1) genetically causal Parkinson's disease, especially for particular sub-types of Parkinson's Disease (PD), including genetic cohorts, biologically defined cohorts of idiopathic PD, or ethnic subgroups of idiopathic PD; 2) the differentiation of synucleinopathies (such as PD and Multiple System Atrophy (MSA) from tauopathies (such as Progressive Supranuclear Palsy and Corticobasal degeneration); or 3) to improve diagnostic differentiation between idiopathic/subtypes of PD and these disorders, as well as from Essential tremor. To further advance research in this area, broad sharing of biospecimens and associated data is a critical feature of the PDBP generally and of this FOA specifically. A timeline including milestones, which will be used to evaluate the application not only in peer review but also in consideration of the awarded project for funding of non-competing award years, is required for all studies.
Lewy Body Dementia Center Without Walls (CWOW) (U54 Clinical Trial Not Allowed)
Funding Opportunity Purpose
The purpose of the Lewy Body Dementia Center Without Walls (CWOW) program is ultimately to understand how toxic species of alpha-synuclein and amyloid-beta produce the clinical pathology characteristic of Lewy Body Dementia. This FOA invites applications that will systematically and comprehensively characterize alpha-synuclein and amyloid-beta subspecies found in human LBD post-mortem brain tissue, identify toxic subspecies and potential mechanisms of toxicity, and characterize any interactions between the proteins that may contribute to increased toxicity and/or explain selective vulnerabilities of cells/circuits. Given the heterogeneity of both alpha-synuclein and beta-amyloid subspecies, applicants will be expected to focus on the use of post-mortem brain tissue from subjects with LBD; human neuronal cultures/slices/organoids, and human blood/stem cells/CSF from subjects with LBD may also be used for this purpose. It is expected that a multi-site, multidisciplinary team with expertise in 1) mapping neuronal protein structure, function, and interactions at multiple levels, and 2) elucidating neurodegenerative mechanisms that are likely to be relevant to LBD, will be necessary. All centers will be expected to produce a publicly-available library of fully characterized alpha-synuclein and amyloid-beta subspecies found in LBD.
Opportunities for Collaborative Research at the NIH Clinical Center (U01 Clinical Trial Optional)
Funding Opportunity Purpose
The goal of this funding opportunity announcement (FOA) is to support collaborative translational research projects aligned with NIH efforts to enhance the translation of basic biological discoveries into clinical applications that improve health. This opportunity is specifically to promote partnerships between NIH intramural investigators (e.g., those conducting research within the labs and clinics of the NIH) and extramural investigators (e.g., those conducting research in labs and clinics outside of the NIH). It will provide support for extramural investigators to take advantage of the unique research opportunities available at the NIH Clinical Center (http://www.cc.nih.gov/translational-research- resources/resources.html) by conducting research projects in collaboration with NIH intramural investigators.
While translating basic research into clinical practice is increasingly difficult, time consuming, and expensive, translational research is crucially important in converting basic scientific discoveries into new diagnostics and therapies for patients. As such, this FOA intends to broaden and strengthen translational research collaborations between basic and clinical researchers both within and outside NIH to accelerate and enhance translational science. All teams must have at least one intramural and one extramural investigator.
This program will provide access for external researchers to the NIH Clinical Center and will leverage the diverse Clinical Center resources, expertise, and infrastructure available to test promising laboratory- and animal-based discoveries with potential implications for disease diagnosis, treatment and prevention. The NIH Clinical Center is a hospital exclusively dedicated to clinical research, thus research is the culture and research studies are routine. Its mission includes the support of clinical studies that are considered intellectually challenging and risky but with the potential of high reward with new breakthroughs in medicine. The special environment of the Clinical Center supports studies that may not be readily supported elsewhere. This may include collaborations that propose targeted increases in new patients enrolled in protocols at the Clinical Center.
Examples of the special resources of the Clinical Center include:
- Large cohorts of patients, including studies of >500 rare diseases;
- The manufacturing and use of newly designed PET ligands for imaging studies; The availability of blood products for special research studies;
- Collaborative opportunities on clinical protocols (http://clinicalstudies.info.nih.gov/) on unique pharmaceutical agents and/or other modes of therapy, or extraordinarily rare diseases with investigators who are known experts;
- A robust training curriculum in clinical research;
- The ability to support long-term clinical studies at minimal cost to patients and their families.
- On-campus amenities (e.g., Family Lodge and Children's Inn to assist patients and families in supportive, home-like environments as they leave their own homes to participate in clinical research; and
- A number of other resources
For entry to the program, projects must have a collaborating Investigator in the NIH Intramural Program. As a collaborative partner, the intramural investigator will be actively involved in the planning and execution of the research project.
Applications for this program will be submitted by the extramural institution with the participation of the intramural investigator(s) integrated into the application as described in the Collaboration Plan, and with the budget requirements for the NIH Clinical Center and intramural investigators included in the Budget form of the application. Funded projects will include an award to the applicant organization which will exclude funds to support the participation of the Clinical Center. Support for intramural participation will first be determined, then provided if applicable by a budget allocation within the NIH. Annual progress reports will be prepared and submitted by the extramural institutions, with the participation and input of the intramural investigator(s) and should include the project findings, publications, impact of the project, a description of which Clinical Center unique resources were utilized and any new intramural- extramural partnerships that developed.
Pathway and Target Identification for Alzheimer's Disease Related Dementias (ADRDs) (U01 Clinical Trial Not Allowed)
Funding Opportunity Purpose
The purpose of the FOA is to support the identification of targets and pathways impacting the pathophysiology of ADRDs, through use of large scale robust and reproducible molecular platforms and extensively phenotyped human brain tissue, biosamples and cell resources.
Structural Biology of Alzheimer's Disease Related Dementias (ADRDs) Proteinopathies (U01 Clinical Trial Not Allowed)
Funding Opportunity Purpose
The purpose of this FOA is to support the structural characterization and validation of protein species (Tau, alpha-synuclein, TDP43, progranulin/granulin, FUS, and beta-amyloid) related to ADRD pathophysiology. Recent advances in cryo-EM and cryo-ET enable analysis of protein species present in frozen autopsy tissues and the dynamics of protein aggregation and subcellular localization in human cell sources, respectively. As these technologies continue to evolve, collaboration across laboratories will be necessary to develop robust protocols for validation of cryo-EM structures. This FOA supports the resolution of ADRD-associated protein species, collaboration with other investigators through an ADRD proteinopathy consortium, and the validation of new structural entities through development of tools to detect the abundance and dynamics of these protein species in human tissue, appropriate animal models and in human cell-based neurological model systems.
Notice of Corrected Expiration Date for PAR-16-112 "Biomarkers Discovery in Parkinsonism (U01)"
Funding Opportunity Purpose
The purpose of this Notice is inform applicants of the new expiration date of PAR-16-112, "Biomarkers Discovery in Parkinsonism (U01)" on January 24th, 2018. NINDS plans to reissue this Funding Opportunity Announcement (FOA) for compliance with FORMS-E.