Multi-Site Cross-Site Inter-Rater and Test-Retest Reliability and Construct Validity of the MarkVCID White Matter...

Area of Science:

• Neurology
• Neuroimaging
• Biomarker Development

Background:

• White matter hyperintensities (WMH) in vascular cognitive impairment and dementia (VCID) can change over time.
• Quantifying WMH changes is crucial for developing effective clinical trials for VCID and Alzheimer's Disease.

Purpose of the Study:

• To assess the reliability of the MarkVCID protocol for measuring white matter hyperintensity (WMH) growth and regression.
• To evaluate the protocol's utility as a biomarker in clinical trials for neurodegenerative diseases.

Main Methods:

• The MarkVCID Consortium conducted multi-site reliability testing (inter-rater and test-retest) of the WMH growth and regression protocol.
• Cognitive test scores were analyzed to explore the construct validity of WMH changes.

Main Results:

• High intraclass correlation coefficient (ICC) values demonstrated excellent test-retest (0.969-0.937) and inter-rater (0.995-0.990) reliability for WMH growth and regression.
• Negative association found between WMH growth and word list long-delay free-recall (p < 0.028).

Conclusions:

• The MarkVCID WMH growth/regression protocol exhibits robust reliability over a one-year period.
• This validated approach is suitable for clinical trials investigating disease-modifying agents for VCID, particularly those impacting WMH dynamics.