NCT07181811

Assessing the Effects of Ongoing Ocrelizumab (OCR) Therapy on Fatigue and Cognition in Veterans With Multiple Sclerosis

Assessing the Effects of Ongoing Ocrelizumab (OCR) Therapy on Fatigue and Cognition in Veterans With Multiple Sclerosis: Utilizing Cognitive Assessment Scales, and Patient-Reported Outcome Measures

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Anza Memon · Federal
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study seeks to assess the effects of long-term ocrelizumab therapy on fatigue (extreme tiredness) as well as cognition (thinking and reasoning skills, such as memory, learning and attention), in veterans with multiple sclerosis. The evaluation will involve cognitive assessment scales (to assess memory, attention and learning abilities), clinical evaluations (to assess nerve function and ability to move), and patient-reported outcome measures (in which you will answer questions about your tiredness, sleep and how you function in daily life). These assessments will occur at baseline (visit 1), 6 month (Visit-2) and 12 months (visit 3) to track changes over time.

Detailed description

This is a prospective, interventional study involving 30 subjects who have been diagnosed with multiple sclerosis (MS) and being treated with ocrelizumab (OCR) for at least one year. This study will be performed at the John D. Dingell, VA Medical Center. All participants will require full informed consent prior to any study- related procedures. All aspects of the study and informed consent forms will be reviewed and approved by the institutional Review Board (IRB). MS patients who have been on OCR- for MS treatment, and enrolled in this study will undergo cognitive and fatigue assessments using the Brief International Cognitive Assessment for MS (BICAMS) and the Modified Fatigue Impact Scale (MFIS), respectively. Importantly, the cognitive and fatigue assessments administered in this study are not currently part of the standard clinical care for MS patients on OCR. By prospectively assigning participants to undergo these additional assessments, this aspect of the study is considered investigational, and findings may contribute to clinical decision-making regarding the incorporation of cognitive and fatigue assessments into routine MS management.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
OTHER	Multiple Sclerosis patients who have been on Ocrelizumab will undergo cognitive and fatigue assessments	The cognitive and fatigue assessments administered in this study are not currently part of the standard clinical care for multiple sclerosis patients on Ocrelizumab. By prospectively assigning participants to undergo these additional assessments, this aspect of the study is considered investigational, and findings may contribute to clinical decision-making regarding the incorporation of cognitive and fatigue assessments into routine management of multiple sclerosis conditions.

Timeline

• Start date: 2025-09-30
• Primary completion: 2028-06-01
• Completion: 2028-06-01
• First posted: 2025-09-18
• Last updated: 2025-09-18

Locations

1 site across 1 country: United States