Clinical trial NCT01250678: Neurocognitive Changes in Patients With Remitting Relapsing Multiple Sclerosis Treated With Natalizumab
Official title: Neurocognitive Changes in Patients With Remitting Relapsing Multiple Sclerosis Treated With Natalizumab
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Sclerosis
Cognitive Impairment
Keywords: multiple sclerosis
cognitive impairment
natalizumab
SDMT
Lead sponsor: Cantonal Hospital of St. Gallen
Sponsor class: OTHER
Collaborators: name: Biogen
First posted: 2010-12-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The Symbol Digit Modalities Test (SDMT)
timeFrame: 3 years
Secondary outcomes:
measure: Multiple Sclerosis Inventory Cognition (MUSIC)
timeFrame: 3 years
measure: TAP subtest Alertness
timeFrame: 3 years
measure: Composite neurocognitive index
timeFrame: 3 years
Other outcomes:
Locations:
city: Saint Gallen
country: Switzerland
facility: Cantonal Hospital of Saint Gallen
Study officials:
affiliation: Cantonal Hospital Saint Gallen
name: Murat Yildiz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yildiz M, Tettenborn B, Radue EW, Bendfeldt K, Borgwardt S. Association of cognitive impairment and lesion volumes in multiple sclerosis--a MRI study. Clin Neurol Neurosurg. 2014 Dec;127:54-8. doi: 10.1016/j.clineuro.2014.09.019. Epub 2014 Oct 14.