Comparison of Campath and Rebif Treatment on Cognition in Multiple Sclerosis (MS)

Relapsing Remitting Multiple Sclerosis Clinical Trial

Official title:

Comparison of Alemtuzumab (Campath®) and High Dose Interferon Beta-1a (Rebif®) Treatment on Cognition in Subjects With Relapsing Forms of MS

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00914758
• Other study ID #: WNRG02
• Status: Enrolling by invitation
• Phase: N/A
• First received: June 3, 2009
• Last updated: June 4, 2009
• Start date: March 2009
• Est. completion date: December 2011

Study information

• Verified date: June 2009
• Source: Washington Neuropsychology Research Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1
• Est. completion date: December 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 50 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing Remitting Multiple Sclerosis
• Sclerosis

Locations

Country	Name	City	State
United States	The Research and Education Institute of Alta Bates Summit Medical Center	Berkely	California
United States	Multiple Sclerosis Center of NE New York, Empire Neurology, PC	Latham	New York
United States	Dartmouth Medical School/Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Associates In Neurology. PSC	Lexington	Kentucky
United States	Multiple Sclerosis Center, University of Rochester Medical Center	Rochester	New York
United States	Springfield Neurology Associates, LLC	Springfield	Massachusetts
United States	MS Center of Greater Washington	Vienna	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Washington Neuropsychology Research Group	Genzyme, a Sanofi Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Stroop Test		Prior to first study-related medication dose and re-assessed at 12 months, 14 months, 24 months, and 26 months	No
Primary	Symbol Digit Modalities Test		Prior to first study-related medication dose and re-assessed at 12 months, 14 months, 24 months, and 26 months	No
Primary	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	No
Primary	Automated Neuropsychological Assessment Metrics		Prior to first study-related medication dose and re-assessed at 12 months, 14 months, 24 months, and 26 months	No
Primary	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	No
Primary	Fatigue Severity Scale		Prior to first study-related medication dose and re-assessed at 12 months, 14 months, 24 months, and 26 months	No
Primary	Epworth Sleepiness Scale		Prior to first study-related medication dose and re-assessed at 12 months, 14 months, 24 months, and 26 months	No
Primary	MS Fatigue Impact Scale		Prior to first study-related medication dose and re-assessed at 12 months, 14 months, 24 months, and 26 months	No
Secondary	MRI data		prior to first study-related medication dose and reassessed at 1 year and 2 years	No