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Review
. 2025 Jan;21(1):e14264.
doi: 10.1002/alz.14264. Epub 2024 Nov 30.

ADNI Biomarker Core: A review of progress since 2004 and future challenges

Leslie M Shaw  1 , Magdalena Korecka  1 , Edward B Lee  1 , Katheryn A Q Cousins  2 , Hugo Vanderstichele  3 , Suzanne E Schindler  4 , Duygu Tosun  5 , Mari L DeMarco  6 , Magdalena Brylska  1 , Yang Wan  1 , Samantha Burnham  7 , Alexandria Sciulli  1 , Amberley Vulaj  1 , Thomas F Tropea  2 , Alice Chen-Plotkin  2 , David A Wolk  2 ; Alzheimer's Disease Neuroimaging Initiative
Affiliations
Review

ADNI Biomarker Core: A review of progress since 2004 and future challenges

Leslie M Shaw et al. Alzheimers Dement. 2025 Jan.

Abstract

Background: We describe the Alzheimer's Disease Neuroimaging Initiative (ADNI) Biomarker Core major activities from October 2004 to March 2024, including biobanking ADNI cerebrospinal fluid (CSF), plasma, and serum biofluid samples, biofluid analyses for Alzheimer's disease (AD) biomarkers in the Biomarker Core and various non-ADNI laboratories, and continuous assessments of pre-analytics.

Results: Validated immunoassay and mass spectrometry-based assays were performed in CSF with a shift to plasma, a more accessible biofluid, as qualified assays became available. Performance comparisons across different CSF and plasma AD biomarker measurement platforms have enriched substantially the ADNI participant database enabling method performance determinations for AD pathology detection and longitudinal assessments of disease progression.

Discussion: Close collaboration with academic and industrial partners in the validation and implementation of AD biomarkers for early detection of disease pathology in treatment trials and ultimately in clinical practice is a key factor for the success of the work done in the Biomarker Core.

Highlights: Describe ADNI Biomarker Core biobanking and sample distribution from 2007 to 2024. Discuss validated mass spectrometry and immunoassay methods for ADNI biofluid analyses. Review collaborations with academic and industrial partners to detect AD and progression. Discuss major challenges, and progress to date, for co-pathology detection. Implementation in the ATN scheme: co-pathology and modeling disease progression.

Keywords: Alzheimer's disease; amyloid PET; biomarkers; cerebrospinal fluid; neuropathologic diagnosis; plasma; pre‐analytical.

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Conflict of interest statement

L.M.S. receives funding from the NIH, the FNIH Biomarker Consortium, and MJFox Foundation for Parkinson's Research; he receives in‐kind support from Fujirebio and Roche for biomarker analyses in the ADNI study; he has served as consultant for Fujirebio, Roche, Biogen and their teaching programs; honoraria and travel expenses for serving on External Advisory Boards for NIH grants to Washington University; E.B.L. receives funding from the NIH, the Delaware Community Foundation; receives honoraria from academic institutions for lectures, honoraria and travel expenses for serving on grant review panels, honoraria and travel expenses for serving on External Advisory Boards for academic centers; serves on the Executive Committee of the American Association of Neuropathologists; K.A.Q.C. receives funding from the NIH and the Department of Defense; H.V. has stock options from ADx NeuroSciences, a company now owned by Fujirebio; S.E.S. receives funding from the Barnes‐Jewish Hospital Foundation and from the NIH; participates in Data Safety Monitoring or Advisory Boards of WHO, University of Washington, University of Indiana, University of Michigan; leadership role in other boards or committees including Greater Missouri Chapter of the Alz Assn, Global CEO initiative workgroup on BBM, Advisor Risk Evaluation for Dementia, FNIH BC project team member for BBM assays; has received in‐kind support from C2N Diagnostics for A42/A40 plasma data provided to Wash U for studies; S.B. is a current employee of Eli Lilly and company and has received Eli Lilly stock as a minor shareholder, has a patent for a Method for Detection of a Neurological Disease; ACP; T.F.T. receives funding from the NIH and NINDS and from the Parkinson Foundation, MJFox Foundation; has received consulting fees from Bial and support for travel from the Parkinson Study Group; D.A.W. receives funding from the NIH, Biogen, PA Department of Health; consulting fees from Qynapse and Eli Lilly; honoraria from Eli Lilly CME; support for attending meetings from the Alz Assn; participation on a Data Safety Monitoring Board by Functional neuromodulation and GSK; no COI reported for M.K., M.L.D., M.B., Y.W., A.S., A.V. Author disclosures are available in the Supporting Information.

Figures

FIGURE 1
FIGURE 1
Timelines for ADNI Biomarker Core major activities. ADNI, Alzheimer's Disease Neuroimaging Initiative.
FIGURE 2
FIGURE 2
(A‐D) Plots for amyloid PET Centiloid values versus (A) CSF Aβ42 concentration; (B) ptau181/Aβ42 ratio; (C) Aβ42/Aβ40 ratio and (D) tau/Aβ42 ratio for all ADNI1/GO/2 participants who had a Florbetapir PET scan within 6 months of the date of the corresponding lumbar puncture. Aβ42, β‐amyloid 1‐42; CSF, cerebrospinal fluid; PET, positron emission tomography.
See this image and copyright information in PMC

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