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)
The "Early- and Late-Stage Clinical Trials for the Spectrum of Alzheimer's Disease/Alzheimer's Disease-Related Dementias and Age-Related Cognitive Decline" grant is a $20 million funding opportunity from the National Institutes of Health, aimed at supporting innovative clinical trials that develop and test pharmacological and non-pharmacological interventions for Alzheimer's disease and age-related cognitive decline over a five-year period.
Description
The funding opportunity from the Department of Health and Human Services, specifically under the National Institutes of Health (NIH), focuses on early- and late-stage clinical trials aimed at addressing Alzheimer's disease (AD) and Alzheimer's disease-related dementias (ADRD). The opportunity encourages applications that propose to develop and implement clinical trials for promising pharmacological and non-pharmacological interventions targeting cognitive, behavioral, and neuropsychiatric changes associated with age-related cognitive decline. It aims to stimulate innovative trial designs and methods to enhance the research landscape in this critical area.
The application process opens on September 17, 2024, with a deadline for submissions set for October 17, 2024. A letter of intent is encouraged but not required. NIA plans to commit approximately $20 million for this initiative in fiscal year 2025, with no budget cap on applications, provided they accurately reflect project needs. The maximum project period is five years, allowing researchers ample time to explore their proposed interventions thoroughly.
This funding opportunity is designed to support both early-stage trials, which may involve pharmacological and non-pharmacological interventions, and late-stage pivotal trials that test the efficacy and safety of these interventions. Applications should address critical elements such as the rationale for the selected population, the mechanisms of action of the interventions, and plans for future clinical development based on findings. There is a strong emphasis on inclusivity and the need for diverse participant recruitment to ensure representative outcomes.
Reviewers will evaluate applications based on various criteria, including the significance of the proposed work, the qualifications of the investigators, and the innovative nature of the proposed interventions. Additionally, all applicants must comply with NIH policies regarding data management and sharing, which will facilitate collaboration and transparency in research findings.