An official website of the United States government
Biomarkers are measurable indicators of normal biological processes, pathogenic processes, or biological responses to exposures or interventions including therapeutic interventions as stated in the Biomarkers, EndpointS, and other Tools (BEST) Glossary/Resource . Biomarker modalities are diverse and can include metrics from molecular (omics), histologic, radiographic (imaging), physiologic, behavioral and/or digital measures that are useful stand alone or in combination with others from one or more modalities. Biomarkers play a pivotal role in early disease detection, diagnosis, and monitoring. Biomarkers can be stand alone or composite, where multiple individual biomarkers together indicate a biological process.
Categories of Alzheimer's Disease (AD) related biomarkers of interest include: 1. Susceptibility/Risk , 2. Diagnostic, 3. Monitoring, 4. Prognostic, 5. Predictive, 6. Response/Pharmacodynamic, and 7. Safety biomarkers. AD and AD related Dementias (AD/ADRD) and cognitive aging biomarkers can be used to assess responses to existing and novel treatments and therefore, are likely to predict clinical benefit, support accelerated or traditional approval of candidate therapeutics, and help identify clinically meaningful endpoints.
The Division of Neuroscience (DN) at NIA is committed to advancing research in the identification, development, and validation of biomarkers for AD/ADRD. DN has also been committed to open science practices in translational and clinical research. One of the ways has been by setting high standards for data and biospecimen sharing in biomarker discovery and validation studies to make these valuable resources available to the research community.
In response to expert recommendations from the National Alzheimer's Disease Research Summits and with the goals of achieving the National Plan to Address Alzheimer's Disease , NIA has outlined several Research Implementation Milestones to identify, develop, and validate biomarkers , both analytically and clinically. Various funding opportunities and research resources are available to advance biomarker development for AD/ADRD, which are listed below.
The full spectrum of AD/ADRD biomarker research supported by NIA, NIH, other Federal and non-Federal funding organizations in the US and internationally, can be found in the International Alzheimer's and Related Dementias Research Portfolio (IADRP ) knowledgebase.
Funding Opportunities
- PAR-25-209 : Analytical and Clinical Validation of Biomarkers for Alzheimer's Disease (AD) and AD-Related Dementias (ADRDs). Program Contact: Yuan Luo, Ph.D.
- PAR-25-036 : Development and Application of PET and SPECT Imaging Ligands as Biomarkers for Drug Discovery and Pathophysiological Studies of CNS Disorders. Program Contact: Alessandra Rovescalli, Ph.D.
PAR-25-331 , PAR-25-332 : Research on Current Topics on Alzheimer's Disease and Related Dementias
- Notices of Special Interest (NOSIs)
- NOT-AG-22-032 : Development of Radiotracers for Diagnosis and Clinical Studies in Alzheimer's Disease (AD) and AD-Related Dementias (ADRDs). Program Contact: Alessandra Rovescalli, Ph.D. , Lorenzo M. Refolo, Ph.D.
- NOT-AG-24-043 : Digital Technology for Early Detection and Monitoring of Alzheimer's Disease and Related Dementias. Program Contact: Yuan Luo, Ph.D.
- NOT-AG-24-030 : Novel Approaches to Diagnosing and Studying Clinical Alzheimer's Disease and Related Dementias. Program Contact: John Hsiao, Ph.D.
- Notices of Special Interest (NOSIs)
Resources: Data, Biospecimens and Experimental Models
- AD Knowledge Portal
- Agora
- The Image Data Archive (IDA)/Laboratory of Neuroimaging (LONI)
- National Alzheimer's Coordinating Center (NACC)
- National Centralized Repository for Alzheimer's Disease and Related Dementias (NCRAD)
NIH Intramural Center for Alzheimer's and Related Dementias (CARD)
- Marmosets as Research Models of Alzheimer's Disease (MARMO-AD)
- The Model Organism Development and Evaluation for Late-Onset Alzheimer's Disease (MODEL-AD)
- MODEL-AD Explorer
Other Biomarker Research Resources
Food and Drug Administration (FDA) Relevant Resources
- About Biomarkers and Qualification
- FDA Evidentiary Framework Guidance
- Drug Development Tool (DDT)
Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) Biomarker Qualification Programs
FDA Approved Products for AD/ADRD
FDA Approved in vitro Diagnostics
- Lumipulse G beta-Amyloid Ratio (1-42/1-40), DEN200072 , Fujirebio Diagnostics, Inc.
- Elecsys beta-Amyloid Ratio (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF, K221842 , Roche Diagnostics.
- Elecsys beta-Amyloid Ratio (1-42) CSF II, Elecsys Total-Tau CSF, K231348 , Roche Diagnostics.
- 23andMe Personal Genome Service (PGS) Genetic Health Risk Test, DEN160026 , 23andMe Inc.
- Helix Genetic Health Risk App for Late-Onset Alzheimer's Disease, K192073 , Helix OpCo, LLC.
- icobrain aria, K240712 , icometrix NV
- BrainSee, DEN220066 , Darmiyan, Inc.
- NeuroQuant, K241098 , CorTechs Labs, Inc.
- FDA Approved Positron Emission Tomography (PET) Tracers
- Amyloid PET
- Amyvid (Florbetapir F-18), NDA 202008 , Avid Radiopharms, Inc.
- Vizamyl (Flutemetamol F-18), NDA 203137 , GE Healthcare.
- Neuraceq (Florbetaben F-18), NDA 204677 , Life Molecular.
- Tau PET
- Tauvid (Flortaucipir F-18), NDA 212123 , Avid Radiopharms, Inc.
- Amyloid PET
Biomarker Programs in the Spotlight
CLEAR-AD: Centrally-linked peripheral biomarkers of AD in multi-ethnic populations , funded by NIA grant U19AG074879 is a cross-disciplinary, multi-institutional program. This program aims to:
- Identify the next generation of AD biomarkers with mechanistic insights
- Establish a precision medicine approach for rigorous multi-omics biomarker discovery and validation in AD
- Discover molecules that can serve as biomarkers and therapeutic targets
- Enhance biomarker research in trial-ready multi-ethnic populations, and
- Generate and share high quality data resources to enable rigorous biomarker research by the wider research community