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Milestone 9.I

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.

Time Required

2014 to 2021

Research Implementation Area


Activities, Funding Initiatives, and Resources

NIH Alzheimer’s Disease Neuroimaging Initiative (ADNI)
NIH PAR-13-148: Biomarkers for Older Controls at Risk for Dementia (BIOCARD) St…
NIH PAR-15-359: Novel Approaches to Diagnosing Alzheimer's Disease & Predicting…
NIH RFA-AG-15-011: Biomarkers of Alzheimer's Disease in Down Syndrome (R01)
NIH PA-16-091: Small Business Alzheimer's Disease Research (R43/R44)
NIH PA-16-092: Small Business Alzheimer's Disease Research (R41/R42)
NIH RFA-AG-16-019: Limited Competition: Alzheimer's Disease Neuroimaging Initia…
NIH PAR-18-183: T1 Translational Research on Aging: Small Business Innovation A…
NIH PAS-18-188: Advancing Research on Alzheimer's Disease (AD) and Alzheimer's-…

Relevant Recommendation(s)

2012 AD Summit Recommendations: 3E