To date, the pipeline of NIA-funded candidate drugs has produced 18 investigational new drug applications to the FDA, with many now in clinical trials or poised to move into trials. Translational science to identify and develop dementia drugs has been a key NIA focus for close to 20 years. A growing support system for dementia drug development Studies will also be required to recruit and enroll diverse cohorts and to broadly share applicable trial data and biosamples. Note that drug candidates evaluated through this program must target non-amyloid/non-tau mechanisms and aim to address cognitive and/or other symptoms in individuals across the continuum of dementia, from pre-symptomatic to more severe stages. This approach aims for a more “seamless” transition by combining these independent studies into a single award and avoiding a lapse in funding or unnecessary time delays after successful Phase 1 studies are completed. This funding opportunity award mechanism requires that studies meet preapproved safety and tolerability milestones to advance from Phase 1 (UG3) to the next phase (UH3). This funding opportunity supports the bundling of Phase 1 through Phase 2a clinical trials to help streamline and accelerate the evaluation of promising novel Alzheimer’s and related dementias drug candidates. To help address these barriers, NIA is thrilled to announce our new Seamless Early-Stage Clinical Drug Development (Phase 1 to 2a) for Novel Therapeutic Agents for the Spectrum of Alzheimer’s Disease and AD-Related Dementias (PAR 23-274). Apply for seamless drug development support by Feb. However, many promising drugs never advance from preclinical stages through human trials due to a number of barriers including the time and costs required at each stage. Research efforts have expanded well beyond amyloid and tau, and many other promising targets for intervention have been identified, such as inflammation, metabolism, and vascular contributions. Recent progress in treating Alzheimer’s includes the FDA approval of Leqembi and promising clinical trial results of donanemab. This is an exciting time of significant momentum and achievement in Alzheimer’s disease and related dementias drug development. Happy birthday to me.Alzheimer's Disease Applications Funding Opportunities Research I was online today and had to actually scroll down to find my birth year in the scrollbar.
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