What question did this study set out to answer?

To evaluate longitudinal trajectories of candidate blood biomarkers and their association with neuroimaging changes and cognitive decline in patients with cerebral small vessel disease.

August 19, 2026Neurological Research and Practice0 citationsOpen Access

Biomarker-based assessment of cerebral small vessel disease progression after ischemic stroke – a prospective cohort study (MA-BIO)

LHLachin HasanovaUniversity Hospital Ulm PKPaula KlassenUniversity Hospital Ulm ANAnastasia NosanovaUniversity Hospital Ulm

Key Points

To evaluate longitudinal trajectories of candidate blood biomarkers and their association with neuroimaging changes and cognitive decline in patients with cerebral small vessel disease.
Prospective, single-center observational cohort study recruiting up to 180 adults with MRI-confirmed cerebral small vessel disease at University Hospital Ulm, Germany.
Participants are stratified into three groups (no acute stroke, acute lacunar stroke, and territorial stroke) with serial follow-up assessments at baseline, 3, 6, and 12 months.
Standardized assessments include blood biomarker profiling, structural MRI (white matter hyperintensity volumes, diffusion tensor imaging), neurovascular ultrasound, cognitive testing, and optional post-mortem autopsy correlation.
Protocol establishes longitudinal 1-year change in white matter hyperintensity volume as the primary endpoint for disease progression.
Secondary endpoints focus on dynamic changes in circulating blood biomarkers, diffusion tensor imaging metrics, cognitive outcomes, and incident cerebrovascular events.

Abstract

Abstract Background Cerebral small vessel disease (CSVD) is a leading cause of ischemic stroke and vascular cognitive impairment, yet currently lacks clinically established biomarkers for monitoring disease activity. While clinical routine magnetic resonance imaging (MRI) can provide quantitative measures of structural brain changes, it does not capture ongoing pathophysiological processes. Blood-based biomarkers offer a minimally invasive approach to detect dynamic changes in CSVD and may provide novel insights into mechanisms of progression and potential targets for intervention. This study aims to evaluate longitudinal trajectories of candidate blood biomarkers and their association with MRI-derived markers and cognitive outcomes in patients with CSVD. Methods In this single-center, prospective observational cohort study at the University Hospital Ulm, Germany, up to 180 adults with MRI-proven evidence of CSVD will be recruited and stratified into three groups: (1) CSVD without acute ischemic stroke, (2) CSVD with acute lacunar ischemic stroke, and (3) CSVD with territorial ischemic stroke. Participants will undergo comprehensive assessments at baseline, at 3, 6, and 12 months after enrollment. The primary outcome is defined as longitudinal changes of White Matter Hyperintensities (WMH) volumes. Secondary outcomes upon one year include DTI-derived measures, changes in blood biomarkers, cognitive performance, clinical functional measures, and incidence of new cerebrovascular events. Imaging, neurovascular ultrasound, and neuropsychological assessments will be conducted using standardized protocols. Clinical primary and secondary outcomes will be correlated to post-mortem CSVD pathology in the brain in prospectively studied patients, who have consented to autopsy. Discussion By integrating blood-based biomarkers with advanced imaging and longitudinal cognitive assessments, this study aims to advance our understanding of CSVD pathophysiology and may identify biomarkers of disease activity. Our findings hopefully inform future precision-medicine approaches and novel therapeutic strategies. Trial registration German Clinical Trials Registry (DRKS00038936), registered February 3, 2026.

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