- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00914758
Comparison of Campath and Rebif Treatment on Cognition in Multiple Sclerosis (MS)
Comparison of Alemtuzumab (Campath®) and High Dose Interferon Beta-1a (Rebif®) Treatment on Cognition in Subjects With Relapsing Forms of MS
Study Overview
Status
Conditions
Detailed Description
The current will use a neuropsychological evaluation capable of detecting the broad range of cognitive difficulties associated with relapsing remitting MS (RRMS). It is a sub-study of an investigation already underway, called Care-MS II, in which participants diagnosed with RRMS are treated with either Campath® or Rebif®. We will observe those participants already assigned to one of the two study arms in Care-MS II and compare cognitive functioning over time of those taking Campath® and those taking Rebif®. We will also compare the change in cognitive functioning for each active group to that of a matched control group. This will help to control for practice effects and help to establish whether either medication helps to truly stabilize cognitive decline (i.e., relative to non-MS controls). We will obtain neurocognitive data at baseline (prior to the first study dose of Campath® or Rebif®), 12 months (before second dose for Campath® participants), 14 months (2 months after the second dose for Campath® participants), 24 months (prior to the third dose for Campath® participants), and 26 months (2 months after the third dose for Campath® participants). The neurocognitive battery will include gold-standard traditional neuropsychology measures as well as newer, validated computerized measures capable of detecting changes in attention and processing speed that are often missed by traditional measures. Since participants in Care-MS II will also have MRI data at baseline, 1 year, and 2 years, cognitive findings will be correlated with MRI data and analyzed in a post-hoc, exploratory manner for the participants with MS.
Hypotheses include:
- 1: Participants taking Campath® will demonstrate relative stability in cognitive functioning relative to those taking Rebif®. Specifically, the cognitive performance of Rebif® participants will decline somewhat over time, but the cognitive performance of Campath® participants will remain stable.
- 2: Participants taking Campath® will demonstrate similar cognitive change (i.e., change in scores over 2 years) as normal, matched controls.
- 3: Participants taking Rebif® will demonstrate greater cognitive change (i.e., change in scores over 2 years) as compared to normal, matched controls.
- 4: Cognitive stability in Campath® participants will correlate with stability in MRI parameters.
- 5: Cognitive change in Rebif® participants will correlate with greater activity on MRI parameters.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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California
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Berkely, California, United States, 94705
- The Research and Education Institute of Alta Bates Summit Medical Center
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Kentucky
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Lexington, Kentucky, United States, 40513
- Associates In Neurology. PSC
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Massachusetts
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Springfield, Massachusetts, United States, 01104
- Springfield Neurology Associates, LLC
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New Hampshire
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Lebanon, New Hampshire, United States, 03756
- Dartmouth Medical School/Dartmouth-Hitchcock Medical Center
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New York
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Latham, New York, United States, 12110
- Multiple Sclerosis Center of NE New York, Empire Neurology, PC
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Rochester, New York, United States, 14642
- Multiple Sclerosis Center, University of Rochester Medical Center
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Virginia
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Vienna, Virginia, United States, 22180
- MS Center of Greater Washington
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Diagnosis of relapsing remitting MS and enrollment in Care-MS II trial
- Non-MS controls must be neurologically healthy (with respect to conditions that impact CNS functioning).
- Participants must be between the ages of 25 and 50.
- Corrected vision of subjects must be no worse than 20/50.
- Participants must have at least 10 years of education.
- Participants must be capable of writing and pressing the buttons on a computer mouse.
- Participants must be capable of understanding and following all test instructions.
Exclusion Criteria:
- Participants with a history of head injury, seizures, or neurological conditions involving the central nervous system (other than MS for the MS groups).
- Participants with upper extremity dysfunction which prohibits them from using a computer mouse.
- Participants who are colorblind.
- Participants with history of psychosis or other severe mental illness.
- Participants with current alcohol/substance abuse.
- Participants taking medications with potential adverse CNS effects
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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MS patients on Campath®
This group is comprised of patients diagnosed with relapsing remitting multiple sclerosis who were assigned to the Campath® treatment arm of the Care-MS II trial, for which this study is a sub-study
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MS patients on Rebif®
This group is comprised of patients diagnosed with relapsing remitting multiple sclerosis who were assigned to the Rebif® treatment arm of the Care-MS II trial, for which this study is a sub-study
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Control group
This group is comprised of non-MS, non-CNS compromised control participants matched in age, education level, and socioeconomic status to the participants in the 2 MS treatment groups
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Paced Auditory Serial Addition Test
Time Frame: Prior to first study-related medication dose and re-assessed at 12 months, 14 months, 24 months, and 26 months
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Prior to first study-related medication dose and re-assessed at 12 months, 14 months, 24 months, and 26 months
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Stroop Test
Time Frame: Prior to first study-related medication dose and re-assessed at 12 months, 14 months, 24 months, and 26 months
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Prior to first study-related medication dose and re-assessed at 12 months, 14 months, 24 months, and 26 months
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Symbol Digit Modalities Test
Time Frame: Prior to first study-related medication dose and re-assessed at 12 months, 14 months, 24 months, and 26 months
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Prior to first study-related medication dose and re-assessed at 12 months, 14 months, 24 months, and 26 months
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Lexical and Categorical Associative Fluency Tests
Time Frame: Prior to first study-related medication dose and re-assessed at 12 months, 14 months, 24 months, and 26 months
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Prior to first study-related medication dose and re-assessed at 12 months, 14 months, 24 months, and 26 months
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Automated Neuropsychological Assessment Metrics
Time Frame: Prior to first study-related medication dose and re-assessed at 12 months, 14 months, 24 months, and 26 months
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Prior to first study-related medication dose and re-assessed at 12 months, 14 months, 24 months, and 26 months
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MS Quality of Life Instrument-54
Time Frame: Prior to first study-related medication dose and re-assessed at 12 months, 14 months, 24 months, and 26 months
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Prior to first study-related medication dose and re-assessed at 12 months, 14 months, 24 months, and 26 months
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Fatigue Severity Scale
Time Frame: Prior to first study-related medication dose and re-assessed at 12 months, 14 months, 24 months, and 26 months
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Prior to first study-related medication dose and re-assessed at 12 months, 14 months, 24 months, and 26 months
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Epworth Sleepiness Scale
Time Frame: Prior to first study-related medication dose and re-assessed at 12 months, 14 months, 24 months, and 26 months
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Prior to first study-related medication dose and re-assessed at 12 months, 14 months, 24 months, and 26 months
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MS Fatigue Impact Scale
Time Frame: Prior to first study-related medication dose and re-assessed at 12 months, 14 months, 24 months, and 26 months
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Prior to first study-related medication dose and re-assessed at 12 months, 14 months, 24 months, and 26 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
MRI data
Time Frame: prior to first study-related medication dose and reassessed at 1 year and 2 years
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prior to first study-related medication dose and reassessed at 1 year and 2 years
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jeffrey Wilken, Ph.D., Washington Neuropsychology Research Group
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WNRG02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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