Relapsing Remitting Multiple SclerosisNCT00914758
Comparison of Campath and Rebif Treatment on Cognition in Multiple Sclerosis (MS)
An observational study of Relapsing Remitting Multiple Sclerosis, run by Washington Neuropsychology Research Group at 7 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 25 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Relapsing Remitting Multiple Sclerosis
- How many people
- 1 participants
- Where
- 7 sitesUnited States
- Study dates
- Mar 2009to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: community sample diagnosed with relapsing remitting multiple sclerosis
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
The Research and Education Institute of Alta Bates Summit Medical Center
Berkely, California, 94705
Multiple Sclerosis Center of NE New York, Empire Neurology, PC
Latham, New York, 12110
Dartmouth Medical School/Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Associates In Neurology. PSC
Lexington, Kentucky, 40513
Multiple Sclerosis Center, University of Rochester Medical Center
Rochester, New York, 14642
Springfield Neurology Associates, LLC
Springfield, Massachusetts, 01104
MS Center of Greater Washington
Vienna, Virginia, 22180
About this study
Official title: Comparison of Alemtuzumab (Campath®) and High Dose Interferon Beta-1a (Rebif®) Treatment on Cognition in Subjects With Relapsing Forms of MS
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.
Read the 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.
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Keywords
- multiple sclerosis, cognition, cognitive functioning, Campath, Rebif, alemtuzumab, interferon
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Paced Auditory Serial Addition Test
Measured: Prior to first study-related medication dose and re-assessed at 12 months, 14 months, 24 months, and 26 months
Stroop Test
Measured: Prior to first study-related medication dose and re-assessed at 12 months, 14 months, 24 months, and 26 months
Symbol Digit Modalities Test
Measured: 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
Measured: Prior to first study-related medication dose and re-assessed at 12 months, 14 months, 24 months, and 26 months
Automated Neuropsychological Assessment Metrics
Measured: 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
Measured: Prior to first study-related medication dose and re-assessed at 12 months, 14 months, 24 months, and 26 months
Fatigue Severity Scale
Measured: Prior to first study-related medication dose and re-assessed at 12 months, 14 months, 24 months, and 26 months
Epworth Sleepiness Scale
Measured: Prior to first study-related medication dose and re-assessed at 12 months, 14 months, 24 months, and 26 months
MS Fatigue Impact Scale
Measured: 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
Measured: prior to first study-related medication dose and reassessed at 1 year and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2009 (estimated)
- Study startMar 2009
- Primary completionOct 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing Remitting Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington Neuropsychology Research Group
- Sponsor type
- University, hospital or other
- Collaborators
- Genzyme, a Sanofi Company
- Investigators
- Jeffrey Wilken, Ph.D., Principal investigator, Washington Neuropsychology Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00914758
- Sponsor's protocol ID
- WNRG02
- Status last verified
- Jun 2009
- First submitted
- 3 Jun 2009
- Last updated
- 5 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Alemtuzumab (Campath®) and High Dose Interferon Beta-1a (Rebif®) Treatment on Cognition in Subjects With Relapsing Forms of MS
- ClinicalTrials.gov ID
- NCT00914758
- Acronym / sponsor ID
- WNRG02
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Keywords
- multiple sclerosis, cognition, cognitive functioning, Campath, Rebif, alemtuzumab, interferon
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Washington Neuropsychology Research GroupUniversity, hospital or other
- Collaborators
- Genzyme, a Sanofi Company
- Study start
- Mar 2009
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 5 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- community sample diagnosed with relapsing remitting multiple sclerosis
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Stroop Test
Time frame: Prior to first study-related medication dose and re-assessed at 12 months, 14 months, 24 months, and 26 months
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
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
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
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
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
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
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
1 secondary outcome
MRI data
Time frame: prior to first study-related medication dose and reassessed at 1 year and 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Wilken, Ph.D. principal investigator
Washington Neuropsychology Research Group
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Relapsing Remitting Multiple Sclerosis, run by Washington Neuropsychology Research Group at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2009.