Neurocognitive Changes in Patients With Remitting Relapsing Multiple Sclerosis Treated With Natalizumab

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01250678
Recruitment Status : Unknown
Verified November 2010 by Cantonal Hospital of St. Gallen.
Recruitment status was:  Not yet recruiting
First Posted : December 1, 2010
Last Update Posted : December 1, 2010
Information provided by:
Cantonal Hospital of St. Gallen

Brief Summary:
Cognitive impairment is seen in about half of patients with relapsing remitting MS. Our knowledge about long term development of cognitive performance under natalizumab therapy is limited. We want to demonstrate with this study that patients treated with ntz improve in neurocognitive tests over the long term.

Condition or disease
Multiple Sclerosis Cognitive Impairment

Detailed Description:

Impaired cognitive function may represent damage to brain regions that are not involved in physical functions, hence may not be detected during routine neurological assessment. Despite the high prevalence of cognitive impairment in MS, cognitive function is not assessed routinely in clinical practice. The perception that cognitive assessments are costly, time-consuming, complicated, and difficult to administer and interpret has contributed, at least in part, to the failure to incorporate cognitive testing into standard clinical evaluation of patients with MS.

Cognitive impairment may also reduce the ability of patients to comprehend and adhere to treatment concepts (Bobholz 2003). Early detection of cognitive impairment is important to initiate therapeutic intervention, even though the optimal treatment of cognitive decline in MS is at the moment controversial.

Preliminary studies suggest an essential role of disease modifying therapies (DMT) in inhibition of cognitive deterioration in patients with MS (Barak 2002, Flechter 2007). Data about long term cognitive performance of multiple sclerosis patients treated with natalizumab is limited. One study demonstrated in MS patients treated with natalizumab an improvement in SDMT (Symbol Digit Modalities Test) of 16.4% over a period of 2 years (Piehl 2010). SDMT is a screening tool for cognitive impairment in MS patients, mainly measuring working memory and speed processing. As SDMT only covers a part of the neurocognitive impairments seen in MS patients, there is a need for further studies to gain a more complete picture.

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Neurocognitive Changes in Patients With Remitting Relapsing Multiple Sclerosis Treated With Natalizumab
Study Start Date : January 2011
Estimated Primary Completion Date : January 2014
Estimated Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Natalizumab

neurocognitive impaired
MS patients treated with natalizumab who at the beginning of the study suffer from cognitive impairment
neurocognitive non-impaired
MS patients treated with natalizumab who at the beginning of the study do not suffer from cognitive impairment

Primary Outcome Measures :
  1. The Symbol Digit Modalities Test (SDMT) [ Time Frame: 3 years ]
    SDMT is an easily administered brief screening tool for cognitive dysfunction in MS. Patients view a key presenting nine numbers paired with symbols. Below the key is an array of symbols paired with empty spaces, the patient's task being to voice the matching number for each symbol as rapidly as possible.

Secondary Outcome Measures :
  1. Multiple Sclerosis Inventory Cognition (MUSIC) [ Time Frame: 3 years ]
    MUSIC is a cognitive screening instrument. It assesses the cognitive core deficit in MS: mental flexibility, attention, information processing speed, memory and inhibitory control and includes also 3 items derived from a factorial analysis to examine cognitive, motor and psychosocial fatigue, respectively.

  2. TAP subtest Alertness [ Time Frame: 3 years ]
    TAP subtest Alertness measures the subject's ability to respond to a visual stimulus and to increase the attentional level in expectance of a stimulus of high priority. The computer-assisted test is given under 2 conditions: Simple reaction time to a visual stimulus (Greek cross) appearing at randomly varying intervals on the monitor screen is measured. In the second condition, the visual stimulus (= critical stimulus) is preceded by a cue sound presented as warning tone.

  3. Composite neurocognitive index [ Time Frame: 3 years ]
    Overall neurocognitive status will be assessed with a composite cognitive index score representing the sum of the scores for the individual tests: TAP subtest Alertness, MUSIC and SDMT.

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
MS-patients will be recruited in the outpatient clinic of the neurology department of the cantonal hospital of Saint Gallen, responsible for treatment of MS patients of Northeast Switzerland.

Inclusion Criteria:

  • Patients between 18 and 55 years at presentation
  • Diagnosis of relapsing-remitting MS according to revised McDonald criteria 2005
  • Patients treated with ntz
  • EDSS under 5.5

Exclusion Criteria:

  • Brain pathology other than MS
  • Known history of head trauma
  • Pure spinal manifestation of demyelization
  • Neuromyelitis optica
  • Primary and secondary progressive MS
  • Benzodiazepine intake within the last three months
  • Relapse within the last three months
  • Steroid intake within the last three months
  • History of severe depressive disorder and/or suicidality, seizure, drug or alcohol abuse
  • No informed consent
  • Insufficient knowledge of German

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01250678

Cantonal Hospital of Saint Gallen Not yet recruiting
Saint Gallen, Switzerland, 9007
Contact: Murat Yildiz, MD    +41 76 764 ext 11 11   
Principal Investigator: Murat Yildiz, MD         
Sub-Investigator: Stafanie Muller, MD         
Sub-Investigator: Jochen Vehoff, MD         
Sponsors and Collaborators
Cantonal Hospital of St. Gallen
Principal Investigator: Murat Yildiz, MD Cantonal Hospital Saint Gallen

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Murat YIldiz, Cantonal Hospital Saint Gallen Identifier: NCT01250678     History of Changes
Other Study ID Numbers: CogNtz
First Posted: December 1, 2010    Key Record Dates
Last Update Posted: December 1, 2010
Last Verified: November 2010

Keywords provided by Cantonal Hospital of St. Gallen:
multiple sclerosis
cognitive impairment

Additional relevant MeSH terms:
Multiple Sclerosis
Cognitive Dysfunction
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Immunologic Factors
Physiological Effects of Drugs