Accelerating development of next-generation drugs for Alzheimer’s and related dementias
This is an exciting time of significant momentum and achievement in Alzheimer’s disease and related dementias drug development. Recent progress in treating Alzheimer’s includes the FDA approval of Leqembi and promising clinical trial results of donanemab.
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. 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.
Apply for seamless drug development support by Feb. 21
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). 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. The first application due date is Feb. 21, 2024.
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 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.
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. Studies will also be required to recruit and enroll diverse cohorts and to broadly share applicable trial data and biosamples.
A growing support system for dementia drug development
Translational science to identify and develop dementia drugs has been a key NIA focus for close to 20 years. 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.
Researchers interested in applying for this funding opportunity should email Akanni or Laurie to discuss their ideas and program requirements at least eight weeks prior to the submission deadline of Feb. 21. If you have general questions or comments on funding options for Alzheimer’s and related dementias drug development, please reach out to the contacts listed on the relevant funding opportunity, contact your NIA program officer, or leave a comment below!