Instrumental validation of free water, peak-width of skeletonized mean diffusivity, and white matter hyperintensities: MarkVCID neuroimaging kits.

To describe the protocol and findings of the instrumental validation of three imaging-based biomarker kits selected by the MarkVCID consortium: free water (FW) and peak width of skeletonized mean diffusivity (PSMD), both derived from diffusion tensor imaging (DTI), and white matter hyperintensity (WMH) volume derived from fluid attenuation inversion recovery and T1-weighted imaging. The instrumental validation of imaging-based biomarker kits included inter-rater reliability among participating sites, test-retest repeatability, and inter-scanner reproducibility across three types of magnetic resonance imaging (MRI) scanners using intra-class correlation coefficients (ICC). The three biomarkers demonstrated excellent inter-rater reliability (ICC >0.94, The three biomarker kits demonstrated very high inter-rater reliability, test-retest repeatability, and inter-scanner reproducibility, offering robust biomarkers suitable for future multi-site observational studies and clinical trials in the context of vascular cognitive impairment and dementia (VCID).

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© 2021 The Authors. Alzheimer's & Dementia: Diagnosis, Assessment & Disease Monitoring published by Wiley Periodicals, LLC on behalf of Alzheimer's Association.

Déclaration de conflit d'intérêts

Dr. Pauline Maillard is a consultant for Boston University, outside of the scope of the current work. Dr. Hanzhang Lu has no conflict of interest to report. Dr. Konstantinos Arfanakis is on the advisory board for External Advisory Committee, NIH‐funded clinical research study titled “Determinants of Incident Stroke Cognitive Outcomes and Vascular Effects on RecoverY Network (DISCOVERY).” Dr. Brian T. Gold has no conflict of interest to report. Dr. Christopher E. Bauer has no conflict of interest to report. Dr. Valentinos Zachariou has no conflict of interest to report. Dr. Lara Stables has no conflict of interest to report. Dr. Danny J.J. Wang has no conflict of interest to report. Dr. Kay Jann has no conflict of interest to report. Dr. Sudha Seshadri is a consultant for Biogen. Dr. Marco Duering reports honoraria for lectures from Pfizer (payment to Dr. Duering), Bayer (payment to Dr. Duering,) and Sanofi Genzyme (payment to institution). is a consultant for Roche Pharma (payment to institution) and Hovid Berhad, and participates on the Executive committee of the VAS‐COG Society. Laura J. Hillmer has no conflict of interest to report. Dr. Gary A. Rosenberg has no conflict of interest to report. Dr. Haykel Snoussi has no conflict of interest to report. Dr. Farshid Sepehrband has a patent pending for Mapping Perivascular Space using magnetic resonance imaging. Dr. Mohamad Habes is a consultant for Biogen on ARIA. Baljeet Singh has no conflict of interest to report. Dr. Joel H. Kramer has received royalties from Pearson, Inc. Dr. Roderick A. Corriveau has no conflict of interest to report. Herpreet Singh has no conflict of interest to report. Kristin Schwab has no conflict of interest to report. Dr. Karl G. Helmer has no conflict of interest to report. Dr. Steven M. Greenberg is a consultant for Roche (payment to Dr. Greenberg) and Washington University/IQVIA (payment to Dr. Greenberg), Bayer (payment to Dr. Greenberg), Biogen (payment to Dr. Greenberg), and receives royalties or licenses from Up‐To‐Date (payment to Dr. Greenberg). Dr. Charles DeCarli is a consultant to Novartis on a safety trial for heart failure. Dr. Arvind Caprihan has no conflict of interest to report. Dr. Claudia L. Satizabal has received support for attending meetings and/or travel from the NIH (payment to Dr. Satizabal).