Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2025-12-25 @ 10:05 PM
Study NCT ID:
NCT00914758
Status:
UNKNOWN
Last Update Posted:
2009-06-05
First Post:
2009-06-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Campath and Rebif Treatment on Cognition in Multiple Sclerosis (MS)
Sponsor:
Washington Neuropsychology Research Group
Organization:
Study Overview
Official Title:
Comparison of Alemtuzumab (Campath®) and High Dose Interferon Beta-1a (Rebif®) Treatment on Cognition in Subjects With Relapsing Forms of MS
Status:
UNKNOWN
Status Verified Date:
2009-06
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: