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

Information source: Cantonal Hospital of St. Gallen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Sclerosis; Cognitive Impairment

Phase: N/A

Status: Not yet recruiting

Sponsored by: Cantonal Hospital of St. Gallen

Official(s) and/or principal investigator(s):
Murat Yildiz, MD, Principal Investigator, Affiliation: Cantonal Hospital Saint Gallen

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.

Clinical Details

Official title: Neurocognitive Changes in Patients With Remitting Relapsing Multiple Sclerosis Treated With Natalizumab

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: The Symbol Digit Modalities Test (SDMT)

Secondary outcome:

Multiple Sclerosis Inventory Cognition (MUSIC)

TAP subtest Alertness

Composite neurocognitive index

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

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

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

Locations and Contacts

Cantonal Hospital of Saint Gallen, Saint Gallen 9007, Switzerland; Not yet recruiting
Murat Yildiz, MD, Phone: +41 76 764, Ext: 11 11, Email: murat@kssg.ch
Murat Yildiz, MD, Principal Investigator
Stafanie Muller, MD, Sub-Investigator
Jochen Vehoff, MD, Sub-Investigator
Additional Information

Starting date: January 2011
Last updated: November 30, 2010

Page last updated: August 23, 2015

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