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

Information source: Washington Neuropsychology Research Group
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Relapsing Remitting Multiple Sclerosis

Phase: N/A

Status: Enrolling by invitation

Sponsored by: Washington Neuropsychology Research Group

Official(s) and/or principal investigator(s):
Jeffrey Wilken, Ph.D., Principal Investigator, Affiliation: Washington Neuropsychology Research Group

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.

Clinical Details

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

Study design: Observational Model: Case Control, Time Perspective: Prospective

Primary outcome:

Paced Auditory Serial Addition Test

Stroop Test

Symbol Digit Modalities Test

Lexical and Categorical Associative Fluency Tests

Automated Neuropsychological Assessment Metrics

MS Quality of Life Instrument-54

Fatigue Severity Scale

Epworth Sleepiness Scale

MS Fatigue Impact Scale

Secondary outcome: MRI data

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

Minimum age: 25 Years. Maximum age: 50 Years. Gender(s): Both.

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

Locations and Contacts

The Research and Education Institute of Alta Bates Summit Medical Center, Berkely, California 94705, United States

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

Additional Information

Starting date: March 2009
Last updated: June 4, 2009

Page last updated: August 20, 2015

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