Simpler Grants.gov #PAR-25-226

NIH Solicitation for Early-Stage Clinical Drug Development for Alzheimer's Disease and Related Dementias

This opportunity from the National Institutes of Health (NIH) seeks applications for a cooperative agreement to advance early-stage clinical drug development for Alzheimer's Disease (AD) and related dementias (ADRD). - Government Buyer: - National Institutes of Health (NIH) - Products/Services Requested: - Bundled phase 1 and phase 1b/2a clinical trials for novel therapeutic agents - Focus on pharmacological interventions (small molecules and biologics) targeting non-amyloid/non-tau mechanisms - Address cognitive and neuropsychiatric symptoms across the AD/ADRD spectrum - Unique/Notable Requirements: - UG3/UH3 phased award mechanism - Applicants must submit bundled protocols for both trial phases - Prespecified safety and tolerability milestones required for progression - Open to a wide range of organizations, including educational, governmental, nonprofit, business, tribal, and international entities - No specific OEMs or vendors are named, as this is a research solicitation - Place of performance and contracting office: National Institutes of Health

Description

This Notice of Funding Opportunity (NOFO) invites applications that bundle independent protocols for phase 1 clinical trials with phase 1b/phase 2a clinical trials to streamline early-stage evaluation of pharmacological interventions for Alzheimer's disease and related dementias. Candidate interventions must engage non-amyloid/non-tau mechanisms and target cognitive and/or neuropsychiatric symptoms across disease stages. The program uses the UG3/UH3 phased award mechanism with prespecified safety and tolerability milestones gating progression from phase 1 to later clinical development stages. Eligible applicants include a wide range of educational, governmental, nonprofit, and business entities.

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