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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by:
Washington Neuropsychology Research Group
ClinicalTrials.gov Identifier:
NCT00914758
First received: June 3, 2009
Last updated: June 4, 2009
Last verified: June 2009
  Purpose

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.


Condition
Relapsing Remitting Multiple Sclerosis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Comparison of Alemtuzumab (Campath®) and High Dose Interferon Beta-1a (Rebif®) Treatment on Cognition in Subjects With Relapsing Forms of MS

Resource links provided by NLM:


Further study details as provided by Washington Neuropsychology Research Group:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Stroop Test [ Time Frame: Prior to first study-related medication dose and re-assessed at 12 months, 14 months, 24 months, and 26 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • MRI data [ Time Frame: prior to first study-related medication dose and reassessed at 1 year and 2 years ] [ Designated as safety issue: No ]

Enrollment: 1
Study Start Date: March 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.
  Eligibility

Ages Eligible for Study:   25 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

community sample diagnosed with relapsing remitting multiple sclerosis

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00914758

Locations
United States, California
The Research and Education Institute of Alta Bates Summit Medical Center
Berkely, California, United States, 94705
United States, Kentucky
Associates In Neurology. PSC
Lexington, Kentucky, United States, 40513
United States, Massachusetts
Springfield Neurology Associates, LLC
Springfield, Massachusetts, United States, 01104
United States, New Hampshire
Dartmouth Medical School/Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New York
Multiple Sclerosis Center of NE New York, Empire Neurology, PC
Latham, New York, United States, 12110
Multiple Sclerosis Center, University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, Virginia
MS Center of Greater Washington
Vienna, Virginia, United States, 22180
Sponsors and Collaborators
Washington Neuropsychology Research Group
Genzyme, a Sanofi Company
Investigators
Principal Investigator: Jeffrey Wilken, Ph.D. Washington Neuropsychology Research Group
  More Information

No publications provided

Responsible Party: Jeffrey Wilken, Ph.D./Executive Director, Washington Neuropsychology Research Group
ClinicalTrials.gov Identifier: NCT00914758     History of Changes
Other Study ID Numbers: WNRG02
Study First Received: June 3, 2009
Last Updated: June 4, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Washington Neuropsychology Research Group:
multiple sclerosis
cognition
cognitive functioning
Campath
Rebif
alemtuzumab
interferon

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Interferon beta 1a
Alemtuzumab
Interferons
Campath 1G
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents

ClinicalTrials.gov processed this record on July 10, 2014