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Limited Competition: Consortium on Biomarker and Outcome Measures of Social Impairment for Use in Clinical Trials in Autism Spectrum Disorder (U19 Clinical Trial Not Allowed)

RFA
Wednesday, November 6, 2019
Tuesday, December 24, 2019
U19
RFA-MH-20-325

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to further validate promising EEG and eye tracking measures that showed promising performance in the recently-completed Autism Biomarkers Consortium for Clinical Trials (ABC-CT) study. The intent of the FOA is to qualify a set of measures that can be used as biomarkers to reduce heterogeneity, and/or as sensitive and reliable objective measures of social impairment in autism spectrum disorders (ASD) clinical trials. The FOA will support a multi-site consortium to conduct a study with three primary aims to replicate and extend previous characterization of the most promising EEG and eye-tracking measures, incorporating suggestions and guidance from the FDA Biomarkers Qualification Program (BQP). A key goal of the Consortium project is to provide a community resource for broad sharing of all data generated including processed/analyzed data, with rapid and timely deposition of data into the National Database for Autism Research (NDAR). All data generated in this project are expected to be deposited in NDAR and will be accessible for use by all qualified investigators. In addition, blood (DNA) samples are expected to be deposited in the NIMH Repository and Genomics Resource for future research use. The Consortium project will assess the following: (1) whether eye-tracking, EEG paradigms, or a combination of the two, have potential utility as stratification biomarkers and/or as sensitive and reliable measures of change in ASD clinical trials; (2) the relationship (correlation) of validated clinical measures (including measures of social impairment) to eye tracking or EEG paradigms; and (3) the feasibility of collecting the same biomarker measures in a younger cohort.

Pediatric HIV/AIDS Cohort Study (PHACS) 2020 (P01 Clinical Trial Not Allowed)

RFA
Monday, October 7, 2019
Friday, December 6, 2019
P01
RFA-HD-20-002

Funding Opportunity Purpose

The purpose of this FOA is to continue support for the Pediatric HIV/AIDS Cohort Study (PHACS) which addresses the clinical course of perinatally acquired HIV infection in adolescents and young adults and the oral and systemic health consequences of in utero and infant exposure to antiretroviral therapy in cohorts of children in the United States.

NIH Blueprint for Neuroscience Research Education Program on Translational Devices (R25 Clinical Trial Not Allowed)

RFA
Friday, September 20, 2019
Tuesday, December 17, 2019
R25
RFA-NS-20-003

Funding Opportunity Purpose

This FOA solicits Research Education Grant (R25) applications to develop and implement a short course focused on (1) steps required for successful medical device development and translation, (2) common technical and strategic challenges, and (3) best-practices and resources for each stage in the process. Applicants may choose to include an extended mentorship plan if they see fit. The short course should address a broad audience, including senior post-doctoral fellows, independent academic researchers, clinician scientists, and small business entrepreneurs interested in developing and translating medical devices to diagnose or treat a nervous system disorder.

Mechanistic Basis of TDP-43-dependent Pathobiology in Common Dementias (R01 Clinical Trial not Allowed)

RFA
Thursday, September 5, 2019
Saturday, November 16, 2019
R01
RFA-NS-20-005

Funding Opportunity Purpose

The purpose of this funding opportunity announcement (FOA) is to support hypothesis-testing research on the systems, cellular and/or molecular mechanisms and consequences of TDP-43 proteinopathy in common dementias using whole animal models, animal/human cellular model systems, as well as postmortem tissue and other biospecimens. Research on TDP-43 proteinopathy in common dementias, including the clinical syndrome of Alzheimer's disease (AD), multiple etiology dementias (MED) and related dementia syndromes is the focus of this FOA. In addition, comparative studies of TDP-43 proteinopathy in common and rare neurodegenerative diseases, as well as during normal aging and in pre-symptomatic disease stages are within scope.

Peripheral Pathology in the Lewy Body Dementias (R01 Clinical Trial Not Allowed)

RFA
Thursday, September 5, 2019
Wednesday, December 4, 2019
R01
RFA-NS-20-014

Funding Opportunity Purpose

The purpose of this initiative is to identify potential biomarkers for the Lewy Body Dementias using non-blood or CSF peripheral specimens and tissues (e.g., autonomic nervous system, skin, salivary gland, GI tract/microbiome, olfactory mucosa, 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 pre-symptomatically and may provide opportunities for early diagnosis and future treatment development.

Clinical Sites for the ECHO IDeA States Pediatric Clinical Trials Network - 2 (UG1 Clinical Trial Required)

RFA
Friday, August 30, 2019
Tuesday, December 3, 2019
UG1
RFA-OD-19-026

Funding Opportunity Purpose

The purpose of this funding opportunity announcement (FOA), issued by the Office of the Director (OD), National Institutes of Health (NIH), is to invite applications from entities/institutions in Institutional Development Award (IDeA)-eligible States to participate in the Environmental Influences on Child Health Outcomes (ECHO) IDeA States Pediatric Clinical Trials Network (ISPCTN) as a Clinical Site. The Clinical Sites of the ISPCTN will: --Conduct multicenter clinical trials research, assuring the participation of children living in rural or underserved communities located in Institutional Development Award (IDeA) states. --Build pediatric research capacity for IDeA states to support the conduct of clinical trials of relevance to rural or underserved children in IDeA states.

Data Coordinating and Operations Center for the ECHO IDeA States Pediatric Clinical Trials Network - 2 (U24 - Clinical Trial Required -Infrastructure)

RFA
Friday, August 30, 2019
Tuesday, December 3, 2019
U24
RFA-OD-19-025

Funding Opportunity Purpose

The purpose of this funding opportunity announcement (FOA), issued by the Office of the Director (OD), National Institutes of Health (NIH), is to invite applications from entities/institutions in Institutional Development Award (IDeA)-eligible States to participate in the Environmental Influences on Child Health Outcomes (ECHO) IDeA States Pediatric Clinical Trials Network (ISPCTN) as the Data Coordination and Operations Center (DCOC). The DCOC will support the Clinical Sites of the ISPCTN to: --Conduct multicenter clinical trials research, assuring the participation of children living in rural or underserved communities located in Institutional Development Award (IDeA) states. --Build pediatric research capacity for IDeA states to support the conduct of clinical trials of relevance to rural or underserved children in IDeA states.

The NINDS Human Cell and Data Repository (U24 - Clinical Trial Not Allowed)

RFA
Friday, August 30, 2019
Wednesday, October 23, 2019
U24
RFA-NS-19-038

Funding Opportunity Purpose

Reissue of RFA-NS-15-009. This Funding Opportunity Announcement (FOA) invites applications to support the National Institute of Neurological Disorders and Stroke (NINDS) Human Cell and Data Repository (NHCDR). The repository will maintain the current collection of fibroblast and induced pluripotent stem cell (iPSC) lines as well as develop, characterize, expand source cells and iPSCs, and where appropriate, genetically modify new high-quality iPSC lines accordance with the NINDS mission. The NINDS Human Cell and Data Repository will distribute human cell resources broadly to qualified academic and industry researchers to advance basic and translational research in neurological disorders.

Regenerative Medicine Innovation Project (RMIP) Investigator-Initiated Clinical Trials (UG3/UH3 Clinical Trial Required)

RFA
Wednesday, August 14, 2019
Saturday, October 19, 2019
UG3/UH3
RFA-HL-20-030

Funding Opportunity Purpose

The National Institutes of Health (NIH) participating Institutes and Centers, in coordination with the U.S. Food and Drug Administration (FDA), seeks highly meritorious clinical trial applications proposing to explore and enable the development of safe and effective regenerative medicine (RM) interventions using adult stem cells. This Funding Opportunity Announcement (FOA), issued as part of the Regenerative Medicine Innovation Project (RMIP), represents one step in fulfilling a statutory provision set forth in the 21st Century Cures Act. Applications submitted in response to this bi-phasic, milestone-driven cooperative agreement FOA are expected to propose highly innovative projects with a focus on solutions to widely-recognized issues in the development of safe and effective RM therapies. Of particular interest are projects using RM products that have undergone appropriate product development and pre-clinical studies and have demonstrated readiness to advance into clinical trials. This FOA seeks Phase I and beyond clinical trial applications that present a strong scientific rationale for the proposed clinical trial and a comprehensive scientific and operational plan. Trials must be relevant to the research mission of one or more participating NIH Institutes and Centers and meet the NIH definition of a clinical trial (see NOT-OD-15-015). Applications are expected to include plans for project management, participant recruitment and retention, performance milestones, conduct of the trial, and dissemination of results. Before the time of award and if applicable, successful applicants must obtain an Investigational New Drug (IND) authorization or Investigational New Device Exemption (IDE) approval to administer the product to humans. Successful applicants proposing the use of adult stem cells as a clinical intervention will be asked to make available representative samples of the source stem cell and clinical-grade stem cell-derived product for in-depth and independ

Molecular Mechanisms of Blood-Brain Barrier Function and Dysfunction in Alzheimer's disease and Alzheimer's related dementias (AD/ADRD) (R01 Clinical Trial Not Allowed)

RFA
Wednesday, July 10, 2019
Thursday, October 10, 2019
R01
RFA-NS-20-004

Funding Opportunity Purpose

The goal of this initiative is to elucidate the mechanistic links between blood brain barrier (BBB) dysfunction, Alzheimers disease (AD) and AD-related dementias (ADRD), and how related comorbidities impact the basic molecular mechanisms of BBB health and function.

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