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

NCT00914758 | Unknown

• 1 other identifier: WNRG02
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 7

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.

Conditions

Relapsing Remitting Multiple Sclerosis

Keywords

multiple sclerosis; cognition; cognitive functioning; Campath; Rebif; alemtuzumab; interferon

Outcome Measures

Primary Outcomes (9)

• 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

  Prior to first study-related medication dose and re-assessed at 12 months, 14 months, 24 months, and 26 months

Secondary Outcomes (1)

• MRI data

  prior to first study-related medication dose and reassessed at 1 year and 2 years

Study Arms (3)

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

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

community sample diagnosed with relapsing remitting multiple sclerosis

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington Neuropsychology Research Group: lead
• Genzyme, a Sanofi Company: collaborator

Study Sites (7)

The Research and Education Institute of Alta Bates Summit Medical Center

Berkely, California, 94705, United States

Location

Associates In Neurology. PSC

Lexington, Kentucky, 40513, United States

Location

Springfield Neurology Associates, LLC

Springfield, Massachusetts, 01104, United States

Location

Dartmouth Medical School/Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Multiple Sclerosis Center of NE New York, Empire Neurology, PC

Latham, New York, 12110, United States

Location

Multiple Sclerosis Center, University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MS Center of Greater Washington

Vienna, Virginia, 22180, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Jeffrey Wilken, Ph.D.

  Washington Neuropsychology Research Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 3, 2009
• First Posted: June 5, 2009
• Study Start: March 1, 2009
• Primary Completion: October 1, 2011
• Study Completion: December 1, 2011
• Last Updated: June 5, 2009

Record last verified: 2009-06

Locations

US (7)