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HEAL Initiative: Early Phase Pain Investigation Clinical Network - Specialized Clinical Centers (U24 Clinical Trial Not Allowed)

RFA
Thursday, April 18, 2019
Tuesday, June 4, 2019
U24
RFA-NS-19-036

Funding Opportunity Purpose

(RFA-NS-19-025 is being reissued to accommodate an additional receipt date). The purpose of this funding opportunity announcement (FOA) is to invite applications for the Specialized Clinical Centers (hubs) of the Early Phase Pain Investigation Clinical Network (EPPIC-Net). EPPIC-Net will serve as the cornerstone of the NIHs Helping to End Addiction Long-term (HEAL) Initiative. EPPIC-Net will provide a robust and readily accessible infrastructure for carrying out in depth phenotyping and biomarker studies in patients with specific pain conditions, and the rapid design and performance of high-quality Phase 2 clinical trials to test promising novel therapeutics for pain from partners in academia or industry. Studies will bring intense focus to patients with well-defined pain conditions and high unmet therapeutic needs. EPPIC-Net will consist of one Clinical Coordinating Center (CCC), one Data Coordinating Center (DCC) and approximately 10 specialized clinical centers (hubs). The purpose of this funding opportunity announcement (FOA) is to invite applications for the hubs within EPPIC-Net. A hub will typically be a regional medical center that will actively enroll subjects into clinical trials and studies performed in EPPIC-Net. Each hub should have ready access to patient populations with specific pain conditions and have expertise in characterization of that pain condition. A hub will additionally provide scientific leadership and administrative oversight to its multiple (2-10) satellite sites (spokes). This FOA solicits applications EPPIC-Net Specialized Clinical Centers. Separate FOAs have been issued to solicit applications for the Clinical Coordinating Center (RFA-NS-18-036) and Data Coordinating Center (RFA-NS-18-035). Clinical trials conducted through EPPIC-Net may come from a variety of sources including the HEAL Partnership, as described above, or from separate NIH funding announcements.

Accelerating Medicine Partnership in Parkinsons disease (AMP PD) unbiased proteomics biofluid analysis (U01 Clinical Trials Not Allowed)

RFA
Friday, April 5, 2019
Thursday, May 30, 2019
U01
RFA-NS-19-028

Funding Opportunity Purpose

The purpose of the FOA is to support unbiased proteomics analysis of matched longitudinal CSF and plasma samples from the Accelerating Medicine Partnership in Parkinson's disease (AMP PD) cohorts using a data independent acquisition (DIA) mass spectrometry platform, with the ultimate goal of identifying PD biomarkers for diagnosis, prognosis and progression. Proteomics data and workflows generated through this initiative will be broadly shared with the research community through the AMP PD Knowledge Portal to enable additional analyses and data integration across the various datatypes available through AMP PD. The proteomics analysis will be staged to include identification of pre-analytical variables, that will inform the optimal handling of 4,500 CSF and plasma samples.

Administrative Supplement for Research on Bioethical Issues

PA
Tuesday, March 12, 2019
Tuesday, May 14, 2019
333
PA-19-217

Funding Opportunity Purpose

The NIH Office of Science Policy (OSP) within the Office of the Director (OD) announces the availability of administrative supplements to support research on bioethical issues to develop and evidence base that may inform future policy directions. Applicants may propose to supplement parent awards focused on bioethics or to add a component related to bioethics to a parent award in which bioethics was not the focus. Areas of high priority research include, but are not limited to, the bioethical, legal, and societal implications of the following: New and emerging technology development and use; clinical and non-clinical data sharing; precision and personalized medicine; research privacy and security; learning healthcare systems; crowdsourcing; participant-driven research and consumer generated data; patient/participant representation in research oversight; special and vulnerable population research; individual or community health, treatment, and/or research disparities; issues related to the inclusion of Tribal and American Indian/Alaska Native populations; current and emerging regulatory environments; innovative study design, conduct, management, and oversight; international research; research on stigmatized conditions; historical analyses of bioethics issues; and novel approaches for enhancing bioethics infrastructure and training.

Functional Target Validation for Alzheimer's Disease-Related Dementias (ADRDs) (UG3/UH3 Clinical Trial Not Allowed)

RFA
Wednesday, March 6, 2019
Tuesday, May 7, 2019
UG3/UH3
RFA-NS-19-015

Funding Opportunity Purpose

This FOA invites applications that propose the comprehensive functional validation of newly identified therapeutic target candidates for Alzheimer's Disease-Related Dementias (ADRDs). This FOA 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 (UG3 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 (UH3 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 FOA must address objectives for both the UG3 and UH3 phases and are expected to have a substantial collaborative effort between independents laboratories. This FOA 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).

Clinical and Biological Measures of TBI-related dementia including Chronic Traumatic Encephalopathy (CTE) (R01 Clinical Trial Not Allowed)

RFA
Monday, February 25, 2019
Tuesday, April 16, 2019
R01
RFA-NS-19-026

Funding Opportunity Purpose

This FOA invites investigation of biological and clinical measures of TBI-related progressive neurodegeneration and neurocognitive decline associated with increased risk for dementia and /or traumatic encephalopathy syndrome (TES) (clinicopathologic diagnostic counterpart to the neuropathological diagnosis of Chronic Traumatic Encephalopathy (CTE)). The overall goal is to advance knowledge of the underlying pathophysiology and clinical characterization of the chronic effects of TBI that distinguish static-chronic TBI cognitive impairment from those that lead to progressive neurodegeneration associated with TES and dementia. Investigations should be conducted in existing, well-characterized populations of patients with a history of TBI, enriched for increased risk of cognitive impairment or dementia, that have been and can continue to be followed longitudinally. A critical feature of this FOA includes the broad sharing of clinical, neuroimaging, physiological, and biospecimen data to further advance research in this area.

Neuropathological Assessment of TBI-related Neurodegeneration and Neurocognitive decline - Center Without Walls (NATBI CWOW) (U54 Clinical Trial Not Allowed)

RFA
Monday, February 25, 2019
Tuesday, April 16, 2019
U54
RFA-NS-19-030

Funding Opportunity Purpose

This FOA invites applications for a multisite study to comprehensively characterize the neuropathological features associated with neurodegeneration and neurocognitive decline in persons with a history of traumatic brain injury (TBI). Investigations should elucidate the contribution of key individual (sex, age at time of injury, time since injury, etc) and injury characteristics (injury severity and frequency) to describe associations between neuropathological burden and antemortem clinicopathologic symptoms, and outline the prevalence of TBI-related parkinsonism, TBI-related Alzheimers, and CTE in the participating brain banks. To further advance research in the area, broad sharing of clinical and neuropathological data will be a critical feature of this FOA including the development of a digital resource for distribution and sharing of assessed neuropathological tissue.

Post-Stroke Vascular Contributions to Cognitive Impairment and Dementia (VCID) in the United States Including in Health Disparities Populations (U19 Clinical Trial not Allowed)

RFA
Friday, February 15, 2019
Thursday, April 18, 2019
U19
RFA-NS-19-012

Funding Opportunity Purpose

The National Institute of Neurological Disorders and Stroke (NINDS) and National Institute on Aging (NIA) intend to publish a Funding Opportunity Announcement (FOA) to solicit applications for a large prospective clinical research study to determine the specific subsets of stroke events that predict cognitive impairment and dementia in post-stroke populations in the United States, including in health disparities populations, and what additional clinical factors and comorbidities along the AD/ADRD spectrum may causally synergize with stroke to result in (or prevent) cognitive impairment and dementia outcomes. The goals of this initiative are to determine the association between specific subsets of stroke events and subsequent cognitive impairment and dementia in post-stroke populations in the United States, including in health disparities populations; to identify additional clinical factors and comorbidities that may affect these associations; and to contribute to development and validation of clinical-trial ready diagnostic and progression biomarkers for post-stroke dementia. It is expected that the study design will also allow for determination of interrelationships (cross-sectional and longitudinal) among the stroke event, overall cerebrovascular and cardiovascular disease and risk factors (including sex, racial, and ethnic differences), dementia-relevant genetic variants (including ApoE) and mutations (e.g. in Notch 3) previously associated with Alzheimer's disease (e.g. APP, PS1, PS2, PICALM, CLU, TREM2), cognitive trajectories including decline and resistance to decline, as well as amyloid and tau biomarkers of Alzheimers pathology during life.

Biological Measures for Prognosing and Monitoring of Persistent Concussive Symptoms in Early and Middle Adolescents: Center Without Walls (PCS-EMA CWOW) (U54 Clinical Trial Not Allowed)

RFA
Thursday, February 7, 2019
Thursday, April 11, 2019
U54
RFA-NS-19-022

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) is aimed at discovering, determining the selectivity and sensitivity, and externally validating biological measures to be used for assessing, prognosing and monitoring recovery of youth who either clinically present with or are at risk for developing prolonged/persistent concussive symptoms following exposure to repetitive head impacts and/or concussion. Resultant biological measures should be incorporated into risk stratification algorithms to inform clinical care and patient stratification for future clinical trials. A critical feature of this FOA includes the broad sharing of clinical, neuroimaging, physiological, and biospecimen data to further advance research in the area of persistent concussive symptoms in children ages 9 - 14.

Clinical Trials Development for Co-Occurring Conditions in Individuals with Down syndrome: Phased Awards for INCLUDE (R61/R33 Clinical Trials Required)

RFA
Tuesday, February 5, 2019
Friday, March 15, 2019
R61/R33
RFA-OD-19-018

Funding Opportunity Purpose

This funding opportunity announcement (FOA) encourages Exploratory/Developmental Phased Innovation (R61/R33) grant applications to support development of clinical trials to treat critical and co-occurring health conditions in individuals with Down syndrome. The proposed research aims should be milestone-driven. The total project period for an application submitted in response to this FOA may not exceed five years. This FOA provides support for up to two years (R61 phase) for preliminary/developmental/planning studies, followed by possible transition of up to four years of expanded clinical trial support (R33), although the total duration of the award may not exceed five years. This FOA requires measurable R61 milestones.

INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Clinical Trial Readiness (R21 Clinical Trial Not Allowed)

RFA
Tuesday, February 5, 2019
Friday, March 15, 2019
R21
RFA-OD-19-015

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) invites researchers to submit applications for support of clinical projects that address critical needs for clinical trial readiness in Down syndrome. The initiative seeks applications that are intended to facilitate Down syndrome research by enabling efficient and effective movement of candidate therapeutics or diagnostics towards clinical trials for Down syndrome and its co-occurring conditions, and to increase their likelihood of success through development and testing of biomarkers and clinical outcome assessment measures, development and testing of novel trial methods and recruitment strategies, or by defining the presentation and course of the co-occurring conditions in individuals with Down syndrome to enable the design of future clinical trials.

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