Seamless Early-Stage Clinical Drug Development (Phase 1 to 2a) for Novel therapeutic Agents for the Spectrum of Alzheimer's Disease (AD) and AD-related Dementias (ADRD) (UG3/UH3 Clinical Trial Required)
ID: 349971Type: Posted
Overview

Buyer

National Institutes of Health (HHS-NIH11)

Eligible Applicants

Others

Funding Category

Health

Funding Instrument

Cooperative Agreement

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes
Timeline
    Description

    The National Institutes of Health (NIH) is inviting applications for a funding opportunity titled "Seamless Early-Stage Clinical Drug Development (Phase 1 to 2a) for Novel Therapeutic Agents for the Spectrum of Alzheimer's Disease (AD) and AD-related Dementias (ADRD)." This initiative aims to support the early evaluation of promising pharmacological interventions that target non-amyloid/non-tau mechanisms to address cognitive and neuropsychiatric symptoms across the Alzheimer's spectrum, combining Phase 1 clinical trials with Phase 1b/Phase 2a trials under a UG3/UH3 phased award mechanism. With the prevalence of Alzheimer's projected to exceed 12 million Americans by 2050, this funding opportunity is crucial for advancing clinical research and addressing the significant economic burdens associated with the disease. Interested applicants must submit their proposals by January 19, 2024, and can direct inquiries to NIH Grants Information at grantsinfo@nih.gov for further details.

    Point(s) of Contact
    Files
    Title
    Posted
    The Department of Health and Human Services is soliciting applications for a funding opportunity titled "Seamless Early-Stage Clinical Drug Development for Alzheimer's Disease (AD) and Related Dementias (ADRD)." The National Institutes of Health (NIH) aims to support the early evaluation of novel pharmacological interventions targeting non-amyloid/non-tau mechanisms to address cognitive and neuropsychiatric symptoms across the Alzheimer's spectrum. Eligible for funding are bundled clinical trials, combining Phase 1 with Phase 1b/Phase 2a trials within a UG3/UH3 phased award framework. Applications must specify safety and tolerability milestones to advance phases, with a submission deadline of January 19, 2024. The initiative targets the growing prevalence of AD, projected to affect over 12 million Americans by 2050, while addressing significant economic burdens. The NIH encourages diversity in research teams and emphasizes transparent data management and sharing for enhanced scientific collaboration. Lastly, the cooperative agreements emphasize substantial involvement from NIH staff, focusing on collective efforts to advance clinical research on AD therapies.
    Similar Opportunities
    Alzheimer's Drug-Development Program (U01 Clinical Trial Optional)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is inviting applications for the Alzheimer's Drug-Development Program (Funding Opportunity Number: PAR-24-223), aimed at supporting the preclinical and early-stage clinical development of innovative drug candidates for Alzheimer's disease (AD). The program focuses on funding activities such as medicinal chemistry, pharmacokinetics, and Investigational New Drug (IND)-enabling studies, with the goal of advancing viable therapies to address the significant public health challenge posed by AD. Eligible applicants include a wide range of organizations, such as higher education institutions, nonprofits, and tribal organizations, with awards reaching up to $1.5 million over a period of up to five years for early-stage projects. Interested parties should submit their applications by November 5, 2027, and can direct inquiries to NIH Grants Information at grantsinfo@nih.gov.
    Early and Late Stage Clinical Trials for the Spectrum of Alzheimers Disease/Alzheimers Related Dementias and Age-Related Cognitive Decline (R01 Clinical Trial Optional)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) has announced a funding opportunity for early and late-stage clinical trials focused on Alzheimer's Disease (AD) and related dementias, as well as age-related cognitive decline. This initiative aims to develop and implement both pharmacological and non-pharmacological interventions to address cognitive and neuropsychiatric changes associated with these conditions, while also encouraging innovative trial designs and methodologies. Given the significant public health crisis posed by AD, which currently affects over six million Americans, this funding opportunity is part of a broader strategy to enhance research and develop effective therapies across the disease spectrum. Applications are due by January 7, 2025, and interested parties can find more information and submit proposals through the NIH ASSIST online system or contact NIH Grants Information at grantsinfo@nih.gov.
    Advancing Research on Alzheimer's Disease (AD) and AD-Related Dementias (ADRD) (R41/R42 Clinical Trial Optional)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is inviting applications for the "Advancing Research on Alzheimer's Disease (AD) and AD-Related Dementias (ADRD)" funding opportunity, aimed at supporting innovative research projects that focus on the prevention, diagnosis, treatment, and care for individuals affected by these conditions. This initiative, part of the Small Business Technology Transfer Research (STTR) program, encourages the development of new therapies, devices, and healthcare programs, with an estimated $4 million allocated for approximately ten grants, including maximum budgets of $500,000 for Phase I and $2.5 million for Phase II awards. The funding opportunity underscores the federal commitment to addressing Alzheimer's research challenges through collaboration and innovation in the biomedical field. Interested applicants can find more information and application guidelines at the provided link, with the closing date for submissions set for September 5, 2025.
    Alzheimer's Drug-Development Program (U01 Clinical Trial Optional)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) has announced the Alzheimer's Drug-Development Program (U01 Clinical Trial Optional), aimed at supporting the pre-clinical and early-stage clinical development of innovative drug candidates for Alzheimer's disease. This funding opportunity focuses on projects that prevent, slow, or treat Alzheimer's disease, with an emphasis on compliance with Good Laboratory Practices (GLP) and Good Clinical Practices (GCP), while excluding basic disease mechanism studies. Eligible applicants include a diverse range of institutions and organizations, with funding available up to $1.5 million in direct costs over project periods of up to five years for early-stage and four years for late-stage projects. Interested parties should submit their applications by November 5, 2024, and can direct inquiries to the NIH OER Webmaster at OERWebmaster03@od.nih.gov.
    Advancing Research on Alzheimer's Disease (AD) and AD-Related Dementias (ADRD) (R43/R44 Clinical Trial Optional)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity aimed at advancing research on Alzheimer's Disease (AD) and AD-related dementias (ADRD) through the Small Business Innovation Research (SBIR) program. This initiative invites U.S. small businesses to submit applications for innovative research projects that could lead to new therapies, diagnostic technologies, or prevention strategies for AD/ADRD. The funding reflects a significant federal commitment to addressing the challenges posed by these conditions, with a total of $20 million anticipated for approximately 40 awards in 2023, providing up to $500,000 for Phase I and $2.5 million for Phase II projects. Interested applicants can find more details and application requirements at the provided link and should note that the application deadline is September 5, 2025. For inquiries, contact the NIH OER Webmaster at OERWebmaster03@od.nih.gov.
    Pilot Studies for the Spectrum of Alzheimers Disease/Alzheimers Disease-Related Dementias and Age-Related Cognitive Decline (R61 Clinical Trial Optional)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is inviting research grant applications for the "Pilot Studies for the Spectrum of Alzheimer's Disease/Alzheimer's Disease-Related Dementias and Age-Related Cognitive Decline" initiative. This funding opportunity aims to collect pilot data to support early-stage testing of both pharmacological and non-pharmacological interventions targeting cognitive and neuropsychiatric changes associated with Alzheimer's Disease (AD) and related dementias (ADRD). The initiative is crucial in addressing the public health crisis posed by these conditions, emphasizing the need for effective therapies and improved trial designs. Interested applicants can apply for grants with an award ceiling of $325,000, with applications due by November 18, 2024. For further inquiries, contact NIH Grants Information at grantsinfo@nih.gov or visit the additional information link at https://grants.nih.gov/grants/guide/pa-files/PAR-23-083.html.
    Optimization of Genome Editing Therapeutics for Alzheimer's Disease-Related Dementias (ADRD) (U01 - Clinical Trials Not Allowed)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity titled "Optimization of Genome Editing Therapeutics for Alzheimer's Disease-Related Dementias (ADRD)" through a U01 cooperative agreement mechanism. This initiative aims to support the optimization of promising genome editing-based therapeutic leads for ADRD, focusing on preparing these candidates for Investigational New Drug (IND)-enabling studies. The funding is crucial for advancing research in various forms of ADRD, including Frontotemporal Dementia and Lewy Body Dementia, by refining therapeutic candidates to ensure their safety and efficacy. Interested applicants can apply for up to $1 million in funding, with a total budget commitment of up to $3 million per year for two awards, and must submit their applications by November 19, 2024. For further inquiries, applicants can contact NIH Grants Information at grantsinfo@nih.gov.
    Research on Current Topics in Alzheimer's Disease and Its Related Dementias (R21 Clinical Trial Optional)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) has announced a funding opportunity for research on Alzheimer's Disease (AD) and its related dementias (ADRD) through the R21 Clinical Trial Optional grant. This grant aims to support innovative research methods and tools that advance understanding and treatment of AD/ADRD, particularly focusing on interdisciplinary studies that require preliminary data for broader application in the field. Given the increasing prevalence of AD and the associated public health concerns, this funding opportunity is crucial for fostering new approaches to address the complexities of the disease and its impact on diverse populations. Interested applicants can apply for up to $275,000 over a two-year period, with the application deadline set for November 12, 2024. For further inquiries, applicants may contact the NIH OER Webmaster at OERWebmaster03@od.nih.gov or visit the additional information link at http://grants.nih.gov/grants/guide/pa-files/PAR-22-094.html.
    Novel Mechanism Research on Neuropsychiatric Symptoms (NPS) in Alzheimer's Dementia (R01 Clinical Trial Optional)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) has announced a funding opportunity aimed at advancing research on neuropsychiatric symptoms (NPS) associated with Alzheimer's disease (AD) and Alzheimer's disease-related dementias (ADRD). This initiative encourages applications for studies that enhance understanding of the mechanisms underlying NPS, such as aggression, anxiety, and sleep disturbances, with the goal of identifying potential therapeutic targets for interventions. The funding opportunity is open to a diverse range of applicants, including universities, non-profits, and governmental agencies, with applications accepted until September 7, 2026. Interested parties can find more information and submit inquiries via email at grantsinfo@nih.gov, and further details are available at the NIH grants website.
    Novel Mechanism Research on Neuropsychiatric Symptoms (NPS) in Alzheimer's Dementia (R21 Clinical Trial Optional)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity titled "Novel Mechanism Research on Neuropsychiatric Symptoms (NPS) in Alzheimer's Dementia," aimed at enhancing the understanding of neuropsychiatric symptoms associated with Alzheimer's disease (AD) and Alzheimer's disease-related dementias (ADRD). This initiative invites exploratory research to identify the neurobiological and behavioral pathways that contribute to symptoms such as aggression, depression, anxiety, and agitation, with the goal of discovering novel therapeutic approaches for treatment. The funding, available through the R21 grant mechanism, supports diverse methodologies and interdisciplinary collaboration, with a maximum budget of $275,000 over two years. Applications are due by September 7, 2026, and eligible applicants include a wide range of institutions and organizations, including educational institutions, non-profits, and foreign entities. For further inquiries, interested parties can contact NIH Grants Information at grantsinfo@nih.gov.