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Biomarkers: Standardizing methods (Milestone 9.I)


Timeline Start - End

2014 - 2025

Research Implementation Area


Develop and test methods for the standardization of immunoassays and mass-spectrometry/single reaction monitoring assay or other methodologies for CSF abeta & tau and other biomarkers as they become clinically applicable.

Develop and test methods for standardization of collection and analysis of MRI and PET neuroimaging data.

Success Criteria

  • Establish CLIA laboratory qualifications in US & the equivalent certification in the EU for at least one CSF biomarker.

  • Establish qualification of at least one neuroimaging biomarker for use in clinical trials by the FDA and/or the EMA.

Summary of Key Accomplishments

The NIA-supported AD Neuroimaging Initiative is developing methods and standards for imaging and fluid biomarkers (cerebrospinal fluid and blood) for the early detection and tracking of AD progression. NIA is currently supporting other major standardization efforts including the Standardized Centralized Alzheimer’s and Related Dementias Neuroimaging project and the Next Generation Translational Proteomics for AD/ADRD project.

Clinical research supported by the NIA enabled the evaluation of amyloid and tau imaging agents, leading to the FDA approval of three amyloid and one tau imaging agent.

The key accomplishments summary is current as of July 2022. 

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