Baseline Results of the Prospective Nationwide Cohort Study in Clinically Isolated Syndromes and Early Multiple Sclerosis of the German Competence Network Multiple Sclerosis and Monocentric Subgroup Analysis of Neuropsychological Findings (P1.392)

Objective:To describe baseline results of a unique large German cohort of early multiple sclerosis (MS), to investigate early neuropsychological findings in the subgroup from one centre.Background:With progress in disease modifying treatments (DMT), accumulation of physical disability seems to be better controlled whereas impact of DMT on evolution of cognitive impairment and “hidden symptoms” such as fatigue is not well known. The German Competence Network Multiple Sclerosis (KKNMS) has been conducting a cohort study of patients with clinically isolated syndrome (CIS) and MS since 2010.Design/Methods:This prospective study recruited DMT-naive adult CIS and early MS patients in 22 centres across Germany. Patients underwent standardized clinical examination, neuropsychological testing and questionnaires, cranial MRI and biosampling and are followed up accordingly for 10 years.Results:1213 patients were enrolled from Aug-2010 to Dec-2014. 84 of 1213 (6.9[percnt]) had to be excluded (inclusion criteria not fulfilled, major data missing). Of 1129 patients, n=351 (31.1[percnt]) were male and n=778 (68.9[percnt]) were female. Mean age at diagnosis was 33.9 years (SD 9.7). Diagnosis at baseline was CIS in 45.0[percnt] (n=508), RRMS in 54.9[percnt] (n=620). Median EDSS at baseline was 1.5 (IQR 1.0-2.0). In the subgroup from one centre (Bochum, n=125), these characteristics were similarly distributed. At baseline, we found 26 patients (23.0[percnt]) with MUSIC results below the lower limit of normal, indicating at least mild cognitive dysfunction, as well as 35 patients (29.9[percnt]) with at least mild fatigue as measured by FSMC (total score).Conclusions:Our monocentric analysis reveals a considerable proportion of patients in earliest MS stages with detectable neuropsychological deficits despite low EDSS. Ongoing analyses investigate associations to clinical and paraclinical measures as well as the expansion to the entire dataset provided by the KKNMS cohort study.Study supported by: German Federal Ministry for Education and Research, BMBF, grant-no. 01GI0914. Disclosure: Dr. von Bismarck has nothing to disclose. Dr. Gisela has nothing to disclose. Dr. Ziegler has nothing to disclose. Dr. Zipp has received personal compensation for activities with Teva, Novartis, Merck Serono, Bayer, Johnson u0026 Johnson, Ono Pharma, Octapharma, and Sanofi. Dr. Tackenberg has received personal compensation for activities with Bayer Pharmaceuticals Corp., Biogen Idec, Merck Serono, Novartis, and Teva Neuroscience. Dr. Tackenberg has received research support. Dr. Then Bergh has received personal compensation for activities with Biogen Idec, Novartis, Merck Serono, and Sanofi-Aventis Pharmaceuticals, Inc. as a speaker and/or advisory board member. Dr. Tumani has received personal compensation for activities with Bayer Pharmaceuticals, Inc., Biogen Idec, Merck Serono, Teva Neuroscience, Roche Diagnostics Corporation, Genzyme Corporation, and Virotech. Dr Kumpfel has received personal compensation for activities with Bayer Healthcare, Teva Pharma, Merck-Serono, Novartis Pharma, Sanofi-Aventis, Genzyme, and Biogen-Idec. Dr. Stangel has received personal compensation for activities with Bayer HealthCare. Dr. Heesen has received personal compensation for activities with Biogen Idec. Dr. Wildemann has received personal compensation for activities with Biogen Idec, Merck Serono, Teva Neuroscience, and Genzyme Corporation. Dr. Paul has received personal compensation for activities with Teva Neuroscience, Sanofi-Aventis Pharmaceuticals, Inc., Bayer Schering Pharma, Merck Serono, Biogen Idec, Medimmune, and Novartis. Dr. Bayas has received personal compensation for activities with Merck Serono, Biogen-Idec, Novartis and Sanofi/Genzyme as a speaker/consultant. Dr. Warnke has received personal compensation in an editorial capacity for CML Multiple Sclerosis. Dr. Weber has received personal compensation for activities with Genzyme, Novartis, and Merck-Serono. Dr. Linker has nothing to disclose. Dr. Ziemann has received personal compensation for activities with Biogen Idec Deutschland GmbH, Bayer Vital GmbH, CorTec GmbH, Medtronic, and Servier as an advisor. Dr. Zettl has received personal compensation for activities with Bayer HealthCare, Biogen, Merck Serono, Novartis, Sanofi, Almirall, and Teva. Dr. Limmroth has received personal compensation for activities with Bayer Pharmaceuticals Inc., Biogen Idec, Novartis, Roche Diagnostics Corp., Sanofi-Aventis Pharmaceuticals Inc., and Teva Neuroscience. Dr. Andrew H K Chan has received research support from Biogen, Genzyme, and Novartis. Dr. Wiendl has received research support from Bayer HealthCare, Biogen Idec, the German Ministry for Education and Research, Deutsche Forschungsgesellschaft, and the Else Kroner Fresenius Foundation. Dr. Hemmer has received personal compensation for activities with Roche, Novartis, Bayer Schering, Merck Serono, Biogen Idec, GSK, Chugai, Micromet and Genzyme Corporation as a scientific advisory board member. Dr. Gold has received research support from Bayer HealthCare, Biogen Idec, Merck Serono, Novartis, and Teva Neuroscience. Dr. Salmen has received personal compensation for activities with Novartis as a speaker.