Tysabri Effects on Cognition and Neurodegeneration in Multiple Sclerosis
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|ClinicalTrials.gov Identifier: NCT01071512|
Recruitment Status : Completed
First Posted : February 19, 2010
Results First Posted : September 6, 2017
Last Update Posted : October 25, 2017
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Drug: Tysabri||Not Applicable|
The specific aims are:
- To determine the effects of Tysabri on cognition (memory, thought processes, etc.)
- To determine the effects of Tysabri on specific MRI markers for cognitive dysfunction
- To determine the effects of Tysabri on retinal nerve fiber layer thickness (RNFL) using optical coherence tomography (OCT), a special instrument used in ophthalmology
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Tysabri Effects on Cognition and Neurodegeneration in Multiple Sclerosis|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||January 2016|
Natalizumab 300 mg IV every 4 weeks
Infuse TYSABRI® 300 mg in 100 mL 0.9% Sodium Chloride Injection, USP over approximately one hour. After the infusion is complete, flush with 0.9% Sodium Chloride Injection, USP. Tysabri will be infused every four weeks.
Other Name: Natalizumab
- Change in Cognitive Function Over Time [ Time Frame: Baseline, 48 weeks, 96 weeks ]Cognitive function was assessed using the oral version of the Symbol Digit Modalities Test (SDMT). The number of correct responses in 90 seconds was recorded (possible range 0-110). For analysis, SDMT scores were converted to z-scores using published age and education based norms. A negative z-score indicates a SDMT score below the mean based on the age and education based norms, for example a z-score of -2 = 2 standard deviations below the mean; a positive z-score indicating a score above the mean. Higher scores indicate better cognitive function.
- Change Over Time in Retinal Nerve Fiber Layer Thickness [ Time Frame: Baseline, 24, 48, 72, and 96 weeks ]Retinal Nerve Fiber Layer (RNFL) thickness was measured using spectral domain OCT scans by a trained technician. Scans were performed without pupil dilation.
- Change Over Time in Brain Parenchymal Fraction [ Time Frame: Baseline, 48 weeks, 96 weeks ]Measured based on MRI scan on a 3T Phillips scanner. This is a measure of brain atrophy (i.e., brain volume loss) with lower values indicating greater atrophy (possible range 0-1).
- Change Over Time in Normalized Thalamic Volume [ Time Frame: Baseline, 48 weeks, 96 weeks ]Measured on MRI scan
- Change Over Time in Normalized Hippocampal Volume [ Time Frame: Baseline, 48 weeks, 96 weeks ]Measured on MRI scan
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01071512
|United States, Illinois|
|University of Chicago|
|Chicago, Illinois, United States, 60637|
|Principal Investigator:||Jacqueline Bernard, M.D.||University of Chicago|