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Assessing the Cognitive Benefits of Ozanimod and Their Brain-Biomarkers in MS

Multiple Sclerosis Clinical Trial

Official title:
Assessing the Cognitive Benefits of Ozanimod and Their Brain-Biomarkers in MS

Clinical Trial Summary

The primary objective of this study is to investigate the cognitive benefits of ozanimod in individuals with Multiple Sclerosis (MS). The study aims to understand the neural basis of cognitive improvement in Relapsing-Remitting MS patients under ozanimod treatment using neuroimaging and behavioral techniques to characterize the brain and behavioral changes due to ozanimod treatment.

Clinical Trial Description

To assess MS patients' cognitive improvement while on ozanimod, the investigators will compare MS patients' baseline performance to the patients' performance following treatment on memory, processing speed, verbal ability and executive function. The investigators predict that cognitive performance will improve during the ozanimod treatment compared to the baseline. Baseline-treatment differences will be assessed using repeated-measures analysis of covariance (ANCOVA) while also controlling for effects of age, education, disease duration, and expanded disability status score (EDSS). The investigators predict that improved cognitive performance will be accompanied by improvements in brain structure (e.g., increased whole brain volume) and function metrics. Thus, each MS patients' brain volume, white matter connectivity, lesion load, and resting BOLD at baseline, during treatment, and after ozanimod treatment will be measured. For each structure and function MR metric, baseline-treatment differences will be assessed using repeated-measures ANCOVA while also controlling for effects of age, education, disease duration, EDSS and brain parenchymal fraction (the ratio of functional brain tissue to whole brain volume). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06334094
Study type Interventional
Source The University of Texas at Dallas
Contact Jessica Ma, BS
Phone (972) 883-3414
Email jxm180043@utdallas.edu
Status Not yet recruiting
Phase Phase 4
Start date June 1, 2024
Completion date May 31, 2028
View Details
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