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

NCT ID: NCT01250678

Last Updated: 2010-12-01

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2014-06-30

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.

Conditions

Multiple Sclerosis; Cognitive Impairment

Keywords

multiple sclerosis; cognitive impairment; natalizumab; SDMT

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

neurocognitive impaired

MS patients treated with natalizumab who at the beginning of the study suffer from cognitive impairment

No interventions assigned to this group

neurocognitive non-impaired

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

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biogen

INDUSTRY

Sponsor Role: collaborator

Cantonal Hospital of St. Gallen

OTHER

Sponsor Role: lead

Responsible Party

Cantonal Hospital Saint Gallen

Principal Investigators

Murat Yildiz, MD

Role: PRINCIPAL_INVESTIGATOR

Cantonal Hospital Saint Gallen

Locations

Cantonal Hospital of Saint Gallen

Sankt Gallen, , Switzerland

Countries

Switzerland

Facility Contacts

Murat Yildiz, MD

Role: primary

References

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.

Reference Type: DERIVED

PMID: 25459243 (View on PubMed)

Other Identifiers

CogNtz

Identifier Type: -

Identifier Source: org_study_id