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This Notice of Funding Opportunity (NOFO) invites new applications for Centers for Collaborative Research in Fragile X andFMR1-Associated Conditions (hereafter termed "Fragile X Centers"). Despite many remarkable advances in fundamental knowledge about FMR1-associated conditions, gaps in knowledge remain about the processes that drive the variability in clinical features (phenotypic heterogeneity) among affected individuals. In this round of competition, therefore, all centers will be required to identify an overarching theme directed at broadening our understanding of factors underlying the phenotypic heterogeneity and/or variability in response to interventions seen in one or more FMR1 associated conditions. Successful Fragile X Centers will be composed of multidisciplinary teams of basic, translational, clinical, and/or data science investigators applying precision medicine approaches (seeking to understand which mechanisms and interventions are most applicable to specific individuals or groups) to address the center's proposed overarching theme. This NOFO includes specific requirements about inclusion of research on human subjects or human phenotypic data; diversity of participants or materials being studied; the types of allowable clinical trials; and involvement of early-stage investigators. Applications that do not adhere to these requirements will be considered nonresponsive to this NOFO and will be withdrawn. In addition, this NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP), which will be assessed as part of the scientific and technical peer review evaluation. Applications that fail to include a PEDP will be considered incomplete and will be withdrawn.Applicants are strongly encouraged to read the NOFO instructions carefully and view the availablePEDP guidance material.

Advances in structural biology have enabled the characterization of large protein assemblies that are linked to AD/ADRD pathology. However, most structural biology approaches require purified samples from cells and tissues or use recombinant bacterial proteins. The derived structures using ex-vivo material may not report the diversity of physiologically relevant species because reconstruction relies on class averaging that is biased towards dominant conformations that survive methodological processing. Recent developments in structural biology offer the possibility of in situ characterization of specific macromolecular assemblies. Structural information of protein assemblies and aggregates in their native cellular and tissue environments could facilitate rational structure-based ligand development. Currently, PET ligands that specifically identify and monitor the accumulation of aggregated and misfolded proteins in AD/ADRD patients are lacking.

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 Funding Opportunity Announcement solicits research applications that propose implementation science methodology to embed existing evidence-based coordinated pain care models into a variety of public and private health care systems (HCS) where this type of care does not exist. Applications that combine comparative effectiveness studies of innovative coordinated care models with strong implementation science methodology to embed effective approaches into HCSs also are encouraged. This NOFO requires that the coordinated care model under study be embedded into the health care delivery system of the applicant institutions. Coordinated pain care approaches proposed for study should include interventions from multiple disciplines as described below and should aim to improve pain management based on the biopsychosocial model of pain. Emphasis should be on populations of patients with greatest need. This NOFO solicits applications from HCS who have resources and infrastructure to support research and implementation of study approaches in partnership with those HCS who lack research resources or experience and would benefit most from implementation of cost-effective coordinated pain care. HCS partners who serve populations that are under-represented in research are encouraged to apply. Models of coordinated care proposed by the study team should be aligned with health care resources of the participating HCS and should be informed through engagement of stakeholders including patients, providers, healthcare system executives, policy makers, and payors. The study teams must include health care providers from multiple disciplines and implementation scientists.

This is a non-competitive funding opportunity intended to fund a single award. The National Institute of Neurological Disorders and Stroke is announcing its intent to issue a single source cooperative agreementto the Hennepin Healthcare Research Institute to submit a renewal application to complete the phase II Hyperbaric Oxygen Brain Injury Treatment (HOBIT) clinical trial.

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.

Senator Paul D. Wellstone Muscular Dystrophy Specialized Research Centers (MDSRC) (P50 Clinical Trial Optional)

The purpose of this Academic Research Enhancement Award (AREA) for Undergraduate-Focused Institutionsis to support small scale research grants at institutions that do not receive substantial funding from the NIH, with an emphasis on providing biomedical research experiences primarily for undergraduate students, and enhancing the research environment at applicant institutions. Eligible institutions must award baccalaureate science degrees and have received no more than $6 million dollars per year of NIH support (in both direct and F and A/indirect costs) in 4 of the last 7 fiscal years. For institutions composed of multiple schools and colleges, the $6 million funding limit is based on the amount of NIH funding received by all the non-health professional schools and colleges within the institution as a whole. See Part II. Section 3.1 Eligible Organizations for more information.

The purpose of this Academic Research Enhancement Award (AREA) for Undergraduate-Focused Institutions is to support small scale research grants at institutions that do not receive substantial funding from the NIH, with an emphasis on providing biomedical research experiences primarily for undergraduate students and enhancing the research environment at applicant institutions. Eligible institutions must award baccalaureate science degrees and have received no more than $6 million dollars per year of NIH support (in both direct and F and A/indirect costs) in 4 of the last 7 fiscal years. For institutions composed of multiple schools and colleges, the $6 million funding limit is based on the amount of NIH funding received by all the non-health professional schools and colleges within the institution as a whole. This Notice of Funding Opportunity (NOFO) supports investigator-initiated mechanistic and/or minimal risk clinical trials addressing the mission and research interests of the participating NIH institutes. For the purpose of this NOFO, minimal risk clinical trials are defined as those that do not require FDA oversight, do not intend to formally establish efficacy, and have low risks to potentially cause physical or psychological harm.

This FOA encourages applications for the Lasker Clinical Research Scholars Program for the purpose of supporting the research activities during the early stage careers of independent clinical researchers. The program offers the opportunity for a unique bridge between the NIH intramural and extramural research communities and contains two phases. In the first phase, Lasker Scholars will receive appointments for up to 5-7 years as tenure-track investigators within the NIH Intramural Research Program with independent research budgets. In the second phase, successful scholars will receive up to 3 years of NIH support for their research at an extramural research facility; or, the Scholar can be considered to remain as an investigator within the intramural program.