Early- and Late-Stage Clinical Trials for the Spectrum of Alzheimer's Disease/Alzheimer's Disease-Related Dementias and Age-Related Cognitive Decline (R01 Clinical Trial Optional)
ID: 355230Type: Posted
Overview

Buyer

National Institutes of Health (HHS-NIH11)

Eligible Applicants

Others

Funding Category

Health

Funding Instrument

Grant

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes
Timeline
    Description

    The National Institutes of Health (NIH) is offering a funding opportunity (RFA-AG-25-011) for early- and late-stage clinical trials focused on Alzheimer's Disease (AD) and Alzheimer’s Disease-Related Dementias (ADRD). The initiative aims to solicit applications for innovative pharmacological and non-pharmacological interventions to prevent and treat cognitive decline associated with these disorders, addressing the growing public health challenge posed by an aging population. Approximately $20 million is available for various-sized clinical trials and method-enhancing studies in fiscal year 2025, with applications opening on September 17, 2024, and closing on October 17, 2024. Interested applicants can find more information and guidelines for submission at NIH Grants and may contact NIH Grants Information at grantsinfo@nih.gov for further inquiries.

    Point(s) of Contact
    Files
    Title
    Posted
    The Department of Health and Human Services, through the National Institutes of Health (NIH), announces a funding opportunity (RFA-AG-25-011) for early- and late-stage clinical trials focusing on Alzheimer's Disease (AD) and Alzheimer’s Disease-Related Dementias (ADRD). The primary goal is to solicit applications for innovative pharmacological and non-pharmacological interventions aimed at preventing and treating cognitive decline associated with these disorders, reflecting the critical need for research as the aging population increases. Approximately $20 million is allocated for various-sized clinical trials and method-enhancing studies in fiscal year 2025. Essential deadlines include the opening date for applications on September 17, 2024, and a final submission date of October 17, 2024. Eligible applicants include a diverse range of organizations, with a strong emphasis on inclusivity in research involving underrepresented populations. Applications must follow stringent guidelines for submission via Grants.gov and adhere to data sharing and resource management plans. The review process will consider the scientific significance, investigator qualifications, innovation, and robust methodologies proposed in each grant application. Ultimately, the funding aims to accelerate effective treatments for AD/ADRD, addressing significant public health challenges and economic burdens associated with these diseases.
    Similar Opportunities
    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.
    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.
    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.
    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.
    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.
    Alzheimer's Disease Research Centers (P30 Clinical Trial Not Allowed)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity for the establishment or renewal of Alzheimer's Disease Research Centers (ADRCs) through Grant Opportunity RFA-AG-24-001. This initiative aims to foster multidisciplinary collaboration and resource sharing among institutions dedicated to researching Alzheimer's Disease (AD) and related dementias (ADRD), with a focus on enhancing diverse perspectives in research. The program will provide a total of $32 million for seven awards in FY 2024, increasing to $65 million for 14 awards in both FY 2025 and FY 2026, with a maximum project budget of $2.925 million per year and a project period of up to five years. Interested applicants can find more information and contact NIH Grants Information at grantsinfo@nih.gov, with the application deadline set for September 26, 2025.
    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)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is inviting applications for the Seamless Early-Stage Clinical Drug Development program, aimed at accelerating the clinical evaluation of novel treatments for Alzheimer’s Disease (AD) and related dementias (ADRD). This funding opportunity utilizes the UG3/UH3 phased award mechanism to streamline the assessment of pharmacological interventions that engage non-amyloid/non-tau mechanisms, requiring applicants to bundle independent protocols for Phase 1 and Phase 1b/Phase 2a clinical trials while achieving specified safety and tolerability milestones. This initiative is critical in addressing the growing human and economic burdens posed by AD and ADRD, reflecting a commitment to innovative treatment development. Interested applicants must adhere to submission guidelines, with the earliest application deadline set for January 19, 2024, and can reach out to NIH Grants Information at grantsinfo@nih.gov for further inquiries.
    Research on Current Topics in Alzheimer's Disease and Its Related Dementias (R01 Clinical Trial Optional)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is inviting applications for the "Research on Current Topics in Alzheimer's Disease and Its Related Dementias (R01 Clinical Trial Optional)" grant, aimed at advancing research on Alzheimer's disease (AD) and related dementias (ADRD). This funding opportunity seeks to support high-priority research initiatives that address the growing public health crisis posed by these conditions, particularly among older adults. Eligible applicants include a diverse range of entities such as educational institutions, non-profits, and tribal governments, with funding decisions based on the scientific merit of proposals and the qualifications of the investigators. Applications are due by November 12, 2024, and interested parties can find more information and contact the NIH OER Webmaster at OERWebmaster03@od.nih.gov for inquiries.
    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.
    Alzheimer's Clinical Trials Consortium (ACTC) Clinical Trials (R01 Clinical Trial Required)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) has announced a Notice of Funding Opportunity (NOFO) for the Alzheimer's Clinical Trials Consortium (ACTC) to support multi-site clinical trials aimed at developing interventions for Alzheimer's disease (AD) and related dementias. This funding opportunity, identified as RFA-AG-25-010, invites applications for clinical trials testing both pharmacological and non-pharmacological approaches to address cognitive and neuropsychiatric symptoms associated with AD, leveraging the ACTC's established trial coordination infrastructure. With an anticipated budget of approximately $10 million for fiscal year 2025, the NIH emphasizes inclusivity in research populations and encourages a diverse range of eligible applicants, including various educational institutions and community organizations. Interested parties must submit their applications by 5:00 PM local time on October 18, 2024, and can direct inquiries to grantsinfo@nih.gov for further information.