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.

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    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.
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