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This RFA will solicit applications for a pivotal phase 3 clinical trial to determine the efficacy of FDA approved monoclonal antibody therapy compared to placebo in diverse "mixed dementia" populations with a focus on vascular contributions. Mixed dementia refers to dementia cases positive for 1) Alzheimer biomarkers, such as amyloid positron emission tomography and/or low cerebrospinal fluid amyloid beta 42 combined with elevated phosphorylated tau; and 2) evidence of vascular contributions based on imaging (white matter disease and/or subclinical infarction). Bayesian approaches with response adaptive randomization to examine specific subgroups are engouraged. Successful applications will be well-powered to determine efficacy in diverse populations representative of the effect of the disease in the United States by sex, race/ethnicity, and geographic distribution. Applications must include patient and community engagement cores that are incorporated into all stages of program development and at all levels of the organizational structure.

The purpose of this initiative is to solicit applications for Senator Paul D. Wellstone Muscular Dystrophy Cooperative Research Centers. These Centers promote collaborative basic, translational, and clinical research, and provide important resources that can be used by the national muscular dystrophy research community. The Centers also provide outstanding environments for the training of new scientists electing to pursue careers conducting research in high priority areas of muscular dystrophy. Furthermore, Center investigators participate in community outreach efforts to increase awareness and convey the importance and implications of their research activities to the patient and advocacy communities.

This NOFO solicits applications for establishing a Center for Exposome Research Coordination (CERC) that will serve the broad biomedical research community by coordinating and advancing exposome research to accelerate precision environmental health. The CERC will engage existing and ongoing exposome initiatives around the globe to promote methodological advancement and best practices, provide training and education, and foster national and international collaborations.

Reissue of RFA-MH-21-205 to comply with DMS Policy. This Notice of Funding Opportunity (NOFO), in support of the NIH Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative, is one of several NOFOs aimed at supporting transformative discoveries that will lead to breakthroughs in understanding human brain function. Guided by the long-term scientific plan, BRAIN 2025: A Scientific Vision, this NOFO specifically seeks to support efforts addressing core ethical issues associated with research focused on the human brain and resulting from emerging technologies and advancements supported by the BRAIN Initiative. The hope is that efforts supported under this NOFO might be both complementary and integrative with the transformative, breakthrough neuroscience discoveries supported through the BRAIN Initiative.

To enable the development and validation of real-world remote digital endpoints from wearable devices for monitoring pain experience and progression, response to interventions, and impact on quality of life. In the context of this RFA, endpoints will include biosignatures derived from functional and physiological assessments detected from wearable devices. These biosignatures can be used to monitor the effects of therapeutics developed for the treatment of pain.

The purpose of this Notice of Funding Opportunity is to solicit applications for clinical sites that will provide expert diagnostic services for undiagnosed diseases across the nation. The clinical sites known as Diagnostic Centers of Excellence (DCoEs) will partner with the Undiagnosed Diseases Network (UDN) to sustain some of the key research activities currently performed by the Phase II UDN Clinical sites (see:RFA-RM-17-019) and facilitate its transition to a larger network that serves diverse undiagnosed patient populations. The DCoEs will establish collaborations and efficient processes with the Data Management and Coordinating Center (DMCC; see: RFA-NS-22-051); enroll and evaluate new participants; and foster scientific discovery. 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 FOA instructions carefully and view the available PEDP guidance material.

The purpose of this notice is to notify applicants of a correction to the table of page limits and Instructions for Submission of Multicomponent Applications for RFA-NS-24-011 "Center without Walls for PET Ligand Development for Alzheimer's disease-related dementias (ADRDs) (U19 - Clinical Trial Optional)".

HIV associated CNS complications are a significant problem for people living with HIV despite suppressive anti-retroviral therapy. HIV enters the CNS as early as 8 days after infection and can cause several complications including cognitive, neurological and mental health related issues. Although experts have gathered much data on underlying HIV-induced CNS pathophysiology, specific targeted causality remains elusive, and no effective therapies exist to slow, stop, or reverse these adverse outcomes. This initiative is to comprehend the actionable biotypes of CNS complications in people living with HIV based on underlying mechanisms to help capture the heterogeneity of outcomes. Identifying biotypes can inform the development of precision treatment strategies for CNS complications seen in people living with HIV.

As part of the NIH's Helping to End Addiction Long-term (HEAL) Initiative, the Eunice Kennedy Shriver National Institute of Child Health and Human Development and participating NIH Institutes and Centers invite applications to this U01 Cooperative Agreement funding opportunity to support innovative, multi-site, large-scale investigator-initiated clinical trials to advance the understanding, assessment, measurement, treatment, and prevention of acute pain in infants, children, and adolescents, including those with disabilities and/or experiencing health disparities. Clinical trials testing behavioral interventions to manage pain as the primary outcome(s) will not be considered as high priority projects. This Notice of Funding Opportunity (NOFO) runs in parallel with a companion NOFO (RFA-HD-24-012) that invites applications for a single HEAL KIDS Pain Resource and Data Center (RDC) to provide the following: leadership in data management, data curation, data harmonization, and the development of data standards; administrative and logistical support including oversight of NIH HEAL-related requirements; and coordination of shared research-related resources for all of the HEAL KIDS Pain research activities.

As part of the NIH's Helping to End Addiction Long-term (HEAL) Initiative, the Eunice Kennedy Shriver National Institute of Child Health and Human Development and participating NIH Institutes and Centers invite applications for a single HEAL KIDS Pain Resource and Data Center (RDC) to provide the following: leadership in data collection and management, data curation, data harmonization, and the development of data standards; administrative and logistical support including oversight of NIH HEAL-related requirements; and coordination of shared research-related resources all for the HEAL KIDS Pain research activities. This Notice of Funding Opportunity (NOFO) runs in parallel with a companion NOFO (RFA-HD-24-011) that invites applications to support innovative, multi-site, large-scale clinical trials to advance the understanding, assessment, measurement, treatment, and prevention of acute pain in infants, children, and adolescents, including those with disabilities and/or experiencing health disparities.