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Background: Cognitive impairment (CI) affects up to 65% of Multiple Sclerosis (MS) patients and is a leading cause of disability. Natalizumab (NTZ) treatment may improve CI in MS patients. However, it is unknown which patients are likely to benefit from NTZ treatment with regard to CI.

Objectives: To observe CI under NTZ treatment over a 2-year period and to assess possible predictors of cognitive improvement in NTZ treated patients.

Methods: We included relapsing-remitting MS patients treated with NTZ in a single-center, observational, prospective study. We excluded patients with other possible causes of CI. Standardized assessments were performed at baseline and thereafter in 6 monthly intervals for 2 years with the Symbol Digit Modalities Test (SDMT), Fatigue Severity Scale (FSS) and Beck Depression Inventory (BDI). CI was defined as a written SDMT score ≤ 49 (age group < 30 years), ≤ 44 (age group 30-55 years) and ≤ 26 (age group >55 years). Repeated measurement analysis was performed using a Mixed Model approach.

Results: We enrolled 46 patients (age 37.3 ± 10.2 years, median EDSS 2.5). CI was found in 23 patients (50%, median SDMT score 44). 16 patients (34.8%) had relevant fatigue symptoms (FSS score 4.4 ± 1.9). 8 patients (17.4%) had relevant depressive symptoms (median BDI score 9). Prior NTZ treatment duration was 27.8 ± 14.3 months. At baseline, cognitive performance was significantly associated with fatigue (p=< 0.001) but not with depressive symptoms or NTZ treatment duration. Cognitive performance during 2 years of NTZ treatment significantly improved in all groups (median SDMT score improved from 44 to 50, p=< 0.001). There was a significant correlation between improvement of CI over time and baseline FSS score (p=0.042) but no significant correlations with baseline SDMT score, BDI score or NTZ treatment duration.

Conclusions: CI is likely to improve over a 2-year period in NTZ treated patients. Baseline fatigue symptoms but not baseline cognitive performance, depressive symptoms or NTZ treatment duration were significantly associated with improvement in CI over time.