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| Name | Class |
|---|---|
| Genzyme, a Sanofi Company | INDUSTRY |
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People with multiple sclerosis (MS) often experience problems with cognitive functioning, which can be debilitating and interfere with their daily functioning. However, research has shown that MS disease modifying agents have had some success in treating cognitive problems. The main purpose of this research study is to investigate how well two medicines (alemtuzumab (Campath®) and interferon beta-1a (Rebif®)) work in treating MS-related cognitive problems (e.g., attention, memory, speed of thinking). Participants enrolled will be assessed prior to their first study-related medication dose and re-assessed throughout treatment. It is expected that 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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | ||
| 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 | ||
| 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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| Measure | Description | Time Frame |
|---|---|---|
| Paced Auditory Serial Addition Test | Prior to first study-related medication dose and re-assessed at 12 months, 14 months, 24 months, and 26 months | |
| Stroop Test | Prior to first study-related medication dose and re-assessed at 12 months, 14 months, 24 months, and 26 months | |
| Symbol Digit Modalities Test | Prior to first study-related medication dose and re-assessed at 12 months, 14 months, 24 months, and 26 months | |
| Lexical and Categorical Associative Fluency Tests | Prior to first study-related medication dose and re-assessed at 12 months, 14 months, 24 months, and 26 months | |
| Automated Neuropsychological Assessment Metrics | Prior to first study-related medication dose and re-assessed at 12 months, 14 months, 24 months, and 26 months | |
| MS Quality of Life Instrument-54 | Prior to first study-related medication dose and re-assessed at 12 months, 14 months, 24 months, and 26 months | |
| Fatigue Severity Scale | Prior to first study-related medication dose and re-assessed at 12 months, 14 months, 24 months, and 26 months | |
| Epworth Sleepiness Scale | Prior to first study-related medication dose and re-assessed at 12 months, 14 months, 24 months, and 26 months | |
| MS Fatigue Impact Scale |
| Measure | Description | Time Frame |
|---|---|---|
| MRI data | prior to first study-related medication dose and reassessed at 1 year and 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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community sample diagnosed with relapsing remitting multiple sclerosis
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Wilken, Ph.D. | Washington Neuropsychology Research Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Research and Education Institute of Alta Bates Summit Medical Center | Berkely | California | 94705 | United States | ||
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| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| Prior to first study-related medication dose and re-assessed at 12 months, 14 months, 24 months, and 26 months |
| Associates In Neurology. PSC |
| Lexington |
| Kentucky |
| 40513 |
| United States |
| Springfield Neurology Associates, LLC | Springfield | Massachusetts | 01104 | United States |
| Dartmouth Medical School/Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| Multiple Sclerosis Center of NE New York, Empire Neurology, PC | Latham | New York | 12110 | United States |
| Multiple Sclerosis Center, University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| MS Center of Greater Washington | Vienna | Virginia | 22180 | United States |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |