Biomarkers: Biomarkers for preclinical/clinical drug development (Milestone 9.A)
In Progress
Timeline Start - End
2016 - 2024Research Implementation Area
BiomarkersDevelop and validate translatable biomarkers for their use in preclinical and clinical drug development. These efforts should include the development of pharmacodynamic biomarkers of target engagement, biomarkers of incipient disease (ocular, olfactory) and biomarkers for detection and tracking of synaptic dysfunction.
Success Criteria
Develop and validate at least 12 translatable biomarkers for use in preclinical and clinical drug development.
Summary of Key Accomplishments
Through the NIA-supported MODEL-AD Centers, researchers are developing translatable biomarkers that can be used in preclinical and clinical drug development. The Centers are developing new mouse models for late-onset AD and are conducting detailed characterization of the most promising models; this includes a collaboration with the Accelerating Medicines Partnership for AD (AMP AD) focused on comparing the molecular signatures from brain and blood samples between the mouse models of late onset AD and people living with AD.
The key accomplishments summary is current as of July 2022.
Accomplishments/Implementation Activities
Funding Initiatives
- PAR-15-359: Novel Approaches to Diagnosing Alzheimer's Disease & Predicting Progression (R01)
- RFA-AG-16-014: Alzheimer's Disease Translational Center for Disease Model Resources (U54)
- PAR-18-519: Sensory and Motor System Changes as Predictors of Preclinical Alzheimer’s Disease (R01)
- PAR-18-596: Research on Current Topics in Alzheimer's Disease and Its Related Dementias (R01)
- NOT-AG-18-001 (#3): in vivo Synaptic Function in Alzheimer's Disease and Related Dementias
- PAR-19-315: Discovery of Biomarkers and Biomarker Signatures for Neurological and Neuromuscular Disorders (R61/R33 Clinical Trial Optional)
- PAR-22-089: Development of Biomarkers or Biomarker Signatures for Neurological and Neuromuscular Disorders (R61/R33 Clinical Trial Optional)
Research Programs and Resources
- Model Organism Development & Evaluation for Late-Onset Alzheimer’s Disease (MODEL-AD)
- Discovery of Novel Proteomic Targets in Alzheimer’s Disease
- The IU/JAX Alzheimer’s Disease Precision Models Center: Metabolomics
- Biomarkers Consortium – Longitudinal Proteomic Changes in CSF from ADNI: Towards Better Defining the Trajectory of Prodromal and Early Alzheimer’s Disease