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NeuroNEXT Clinical Trials (U01 Clinical Trial Optional)

PAR
Wednesday, May 5, 2021
small business, Clinical Trials Research
Wednesday, March 6, 2024
U01
PAR-21-223
Codrin Lungu

Funding Opportunity Purpose

This FOA encourages applications for exploratory clinical trials of investigational agents (drugs, biologics, surgical therapies or devices) that may contribute to the justification for and provide the data required for designing a future trial, for biomarker validation studies, or for proof of mechanism clinical studies. Diseases chosen for study should be based on the NINDS' strategic plan and clinical research interests (www.ninds.nih.gov/funding/areas/index.htm). Successful applicants will be given access to the NeuroNEXT infrastructure. Following peer review, NINDS will prioritize and order trials that are given access to the NeuroNEXT infrastructure. The NeuroNEXT Clinical Coordinating Center (CCC) will work with the successful applicant to efficiently implement the proposed study. The NeuroNEXT Data Coordinating Center (DCC) will provide statistical and data management support. The NeuroNEXT clinical sites will provide recruitment/retention support as well as on-site implementation of the clinical protocol. Applicants do not need to be part of the existing NeuroNEXT infrastructure.

NeuroNEXT Small Business Innovation in Clinical Trials (U44 Clinical Trial Optional)

PAR
Wednesday, May 5, 2021
small business, Clinical Trials Research
Saturday, April 6, 2024
U44
PAR-21-224
Codrin Lungu

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) encourages small business applications for exploratory clinical trials of investigational agents (drugs, biologics, surgical therapies or devices) that may contribute to the justification for and provide the data required for designing clinical studies. Diseases chosen for study should be based on the NINDS strategic plan and clinical research interests (www.ninds.nih.gov/funding/areas/index.htm). Successful applicants will be given access to the NeuroNEXT infrastructure. Following peer review, NINDS will prioritize and order trials that are given access to the NeuroNEXT infrastructure. The NeuroNEXT Clinical Coordinating Center (CCC) will work with the successful applicant to efficiently implement the proposed study. The NeuroNEXT Data Coordinating Center (DCC) will provide statistical and data management support. The NeuroNEXT clinical sites will provide recruitment/retention support as well as on-site implementation of the clinical protocol. Applicants do not need to be part of the existing NeuroNEXT infrastructure.

Notice of Special Interest (NOSI): Administrative Supplements to Promote Diversity for NINDS Alzheimer's Disease and Alzheimer's Disease-Related Dementias (AD/ADRD) Awardees

Notice of Special Interest
Thursday, April 22, 2021
Sunday, March 31, 2024
333
NOT-NS-21-047

Funding Opportunity Purpose

The purpose of this NOSI is to encourage eligible NINDS awardees in the Alzheimers Disease and Alzheimers Disease-Related Dementias (AD/ADRD) research community to apply for administrative supplements in response to PA-21-071, "Research Supplements to Promote Diversity in Health-Related Research," or any reissues of this announcement through the expiration date of this Notice. The NIH has a strong interest in the diversity of the NIH-funded workforce (see NOT-OD-20-031 for details) and encourages institutions to diversify their student populations by enhancing the participation of individuals from groups that are underrepresented in the biomedical, clinical, behavioral, and social sciences. Goal 1 of The National Plan to Address Alzheimers Disease is to prevent and effectively treat AD/ADRD by 2025. This initiative addresses the critical need to increase the number of health professionals who are trained to meet the expanding demand for cognitive impairment and dementia diagnosis, care, and clinical research to meet Goal 1.

Notice of Special Interest (NOSI): Characterization of Genomics of Induced Pluripotent Stem Cell Lines for AD/ADRD Research

Notice of Special Interest
Tuesday, March 23, 2021
Thursday, May 6, 2021
333
NOT-NS-21-041

Funding Opportunity Purpose

The purpose of this one year administrative supplement program is to provide deep quality control and molecular phenotyping of ADRD iPSC lines. This program will fund whole genome sequencing (WGS) to fully characterize the genomic integrity of iPSC lines and compare against matched donor DNA WGS (ongoing through other support) for detecting mutation rates between the sources of DNA, source cell material (PBMC & fibroblasts). RNA-Seq and DNA methylation array analysis for the iPSC lines will provide gene expression profiles and methylation signatures to the respective parental cell type to assess the extent somatic memory exists and if this varies across different reprograming protocols. Additionally, we would utilize these data to determine whether somatic mutations occurring during reprogramming have functional consequences in gene expression patterns. This supplement will extend the scientific goals of the NINDS Human Cell and Data Repository (NHCDR) by providing insights into how genetic variants influence convergent ADRD disease pathways.

Notice of Special Interest (NOSI): Administrative Supplements for Collaborative Activities to Promote Sleep/Circadian Research in ADRD

Notice of Special Interest
Tuesday, March 16, 2021
Thursday, May 6, 2021
333
NOT-NS-21-040

Funding Opportunity Purpose

Between 40 and 70% of older adults suffer from sleep disturbances or disorders, which are especially prevalent among patients with Alzheimer's Disease and Alzheimers Disease Related Dementias (AD/ADRD), i.e., frontotemporal dementia, Lewy body dementia, vascular contributions to cognitive impairment and dementia, and multiple etiology dementias. The AD Research Summits specifically recommends to invest in understanding the integrative physiology of sleep and elucidating the short- and long-term consequences of disrupted and optimized sleep on brain aging and AD. Moreover, NIAs AD/ADRD Research Implementation Milestone 2.F plans to "create new research programs aimed at understanding the integrative physiology of circadian rhythms and sleep and its impact on brain aging and the risk of AD and AD-related dementias at multiple levels (epigenetic, gene expression, proteomic, neuronal, network, systems) to identify new targets and approaches for AD prevention." The purpose of this one-year administrative supplement program is to facilitate collaborative research to better understand the bi-directional relationship between chronic sleep disturbances/circadian disruption and AD/ADRD pathogenesis. This notice encourages eligible NINDS awardees in the AD/ADRD research community to apply for supplemental funds to establish new collaborations with sleep/circadian researchers for the advancement of research on the association between sleep disturbances/circadian disruption with ADRD. This initiative aims to investigate the potential of sleep/circadian-related treatment as a modifier of the development and progression of neurodegeneration. The proposed studies must be within the scope of the peer-reviewed activities specified within the NINDS parent award, and collaborators may not have a prior history of collaboration. Active awards with project end dates in FY 2022 or later are eligible. The award may not be entering or in a terminal no-cost extension in FY 2021.

Notice of Special Interest: Impact of COVID-19 on Dementia Risk, Progression and Outcomes in ADRD Populations

Notice of Special Interest
Monday, March 15, 2021
Thursday, May 6, 2021
333
NOT-NS-21-037

Funding Opportunity Purpose

NINDS is interested in supplementing applications to conduct research on the effects of COVID-19 on the development of, or disease progression in, AD/ADRD. For example, anosmia is a risk factor for developing LBD and AD dementiaand anosmia is a common sequelae of COVID-19 infection, but it is unclear whether COVID-19 infected individuals with anosmia are also at greater risk for developing cognitive impairment and dementia. Similarly, although subjects with AD/ADRD are likely to worsen cognitively during COVID-19 infection, research is lacking as to whether they return to baseline after recovery from infection or whether there is accelerated progression of cognitive decline. Applicants requesting supplements to active NINDS-funded human subjects projects that will address these research questions, for example bytesting for COVID-19, anosmia, cognitive assessments, and biomarker assessments (neuroimaging, fluid-based), are encouraged under this opportunity.

Notice of Special Interest: Innovative Approaches or Technologies to Investigate Regional, Structural and Functional Heterogeneity of CNS Small Blood and Lymphatic Vessels in AD/ADRD

Notice of Special Interest
Friday, March 12, 2021
Thursday, May 6, 2021
NOT-NS-21-039

Funding Opportunity Purpose

The purpose of this one-year administrative supplement is to expand the scope of the currently active awards supported by the Blueprint RFAs on the Neurobiology of Small Blood and Lymphatic Vessels (RFAs NS-18-003 and NS-18-004) to advance the mechanistic understanding and/or the development of new technologies to investigate changes in brain small vessels that can lead to Alzheimers Disease and Alzheimers Disease Related Dementias (AD/ADRD). Areas of interest include: alterations in the brain (g)lymphatic system, cerebral microinfarcts and microbleeds, post-stroke cognitive impairment, and vascular contributions to cognitive impairment and dementia, with an emphasis on the microvasculature.

HEAL Initiative: Analgesic Development Initial Translational Efforts [Small Molecules and Biologics] (U19 Clinical Trial Not Allowed)

RFA
Thursday, March 11, 2021
Wednesday, October 11, 2023
U19
RFA-NS-21-015

Funding Opportunity Purpose

This funding opportunity announcement (FOA) is part of a suite of FOAs to support the development of safe, effective, and non-addictive therapeutics to treat pain. The goal of this FOA is to support team-based research projects to develop assays, screening and early optimization work to develop a non-addictive therapeutic to treat pain. Discovery and validation of pharmacodynamic markers efficacy and pharmacokinetic/pharmacodynamic (PK/PD) studies are also responsive. The result of the project should be to advance a hit or lead to the point where they can meet the entry criteria for RFA-NS-21-010 HEAL Initiative: Non-addictive Analgesic Therapeutics Development [Small Molecules and Biologics] to Treat Pain (UG3/UH3 Clinical Trial Optional) within the 5 years of the award, there is no opportunity for renewal of this award. Applications should propose a plan that will lead to the development of analgesics with a rigorous biological rationale and scientifically sound assays. If the data does not currently exist, the proposal must include a strong plan for developing data linking the putative therapeutic target(s) to the proposed pain indication and supporting the hypothesis that altering the target activity will produce desirable outcomes for the disease. This FOA is not specific for any one or group of pain conditions. Projects to develop therapeutics for acute pain, chronic pain, painful neuropathy, musculoskeletal pain, headache disorders, osteoarthritis, diabetic neuropathy, chemotherapy-induced neuropathy, eye pain, sickle-cell pain, post-surgical pain, cancer pain, visceral pain, post stroke pain, myofascial pain, painful disorders of the orofacial region and other conditions will be considered.

HEAL Initiative: Planning Studies for Initial Analgesic Development Initial Translational Efforts [Small Molecules and Biologics] (R34 Clinical Trial Not Allowed)

RFA
Thursday, March 11, 2021
Heal
Wednesday, October 11, 2023
R34
RFA-NS-21-016

Funding Opportunity Purpose

The goal of this funding opportunity announcement (FOA) is to solicit Initial Analgesic Development R34 applications that propose 2-year exploratory/planning awards that are expected to enable a future application for RFA-NS-21-015 HEAL Initiative: Team Research - for Initial Translational Efforts in Non-addictive Analgesic Development [Small Molecules and Biologics] (U19 Clinical Trial Not Allowed). Thus, the limited scope of aims and approach of these applications are expected to establish a strong research team, feasibility, validity, or other technically qualifying results that support, enable, and/or lay the groundwork for a subsequent Team Research U19 application. These R34 awards will support the building of a research team to collect initial data and recruit additional collaborators. The proposal must include a plan for developing a strong research team, as well as a strategy to collect preliminary data linking putative therapeutic targets to the proposed pain indication and supporting the hypothesis that altering target activity will produce desirable outcomes for the disease.

HEAL Initiative: Team Research for Initial Translational Efforts in Non-addictive Analgesic Therapeutics Development (U19 Clinical Trial Not Allowed)

RFA
Thursday, March 11, 2021
Heal
Wednesday, October 11, 2023
U19
RFA-NS-21-015

Funding Opportunity Purpose

This funding opportunity announcement (FOA) is part of a suite of FOAs to support the development of safe, effective, and non-addictive therapeutics to treat pain. The goal of this FOA is to support team-based research projects to develop assays, screening and early optimization work to develop a non-addictive therapeutic to treat pain. Discovery and validation of pharmacodynamic markers efficacy and pharmacokinetic/pharmacodynamic (PK/PD) studies are also responsive. The result of the project should be to advance a hit or lead to the point where they can meet the entry criteria for RFA-NS-21-010 HEAL Initiative: Non-addictive Analgesic Therapeutics Development [Small Molecules and Biologics] to Treat Pain (UG3/UH3 Clinical Trial Optional) within the 5 years of the award, there is no opportunity for renewal of this award. Applications should propose a plan that will lead to the development of analgesics with a rigorous biological rationale and scientifically sound assays. If the data does not currently exist, the application must include a strong plan for developing data linking the putative therapeutic target(s) to the proposed pain indication and supporting the hypothesis that altering the target activity will produce desirable outcomes for the disease. This FOA is not specific for any one or group of pain conditions. Projects to develop therapeutics for acute pain, chronic pain, painful neuropathy, musculoskeletal pain, headache disorders, osteoarthritis, diabetic neuropathy, chemotherapy-induced neuropathy, eye pain, sickle-cell pain, post-surgical pain, cancer pain, visceral pain, post stroke pain, myofascial pain, painful disorders of the orofacial region and other conditions will be considered. Projects to develop analgesics for a combination of chronic overlapping pain conditions or for specific disease or pathological conditions will also be considered. Projects that seek to identify pain treatment targets in specific populations such as women, children, older adults, and other underrepresented groups will also be responsive to this FOA. Input from patients and caregivers on the therapeutic goals of the project is encouraged. The goal of each 5-year U19 application should be to identify candidate therapeutic(s) that will be ready to be submitted to RFA-NS-21-010 for further optimization.

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