Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06334094
Status:
WITHDRAWN
Last Update Posted:
2024-03-27
First Post:
2024-02-26
Brief Title:
Assessing the Cognitive Benefits of Ozanimod and Their Brain-Biomarkers in MS
Sponsor:
The University of Texas at Dallas
Organization:
The University of Texas at Dallas
Study Overview
Official Title:
Assessing the Cognitive Benefits of Ozanimod and Their Brain-Biomarkers in MS
Status:
WITHDRAWN
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The funding for the study was revoked As such the study is no longer being conducted
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 eg 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IM047-1054 | OTHER_GRANT | Bristol Myers Squibb | None |