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Effects of Dimethyl Fumarate on Cognitive Performance and Brain Abnormalities in Multiple Sclerosis.

NCT05811949

CompletedN/A

Sponsor: IRCCS Centro Neurolesi Bonino Pulejo

Conditions: Multiple Sclerosis

Interventions: Dimethyl Fumarate 240 MG [Tecfidera]

Countries: Italy

The goal of this observational study is to evaluate the slowing/reduction of cognitive dysfunction progression and to evaluate grey matter (GM) and thalamus structural changes in Relapsing-Remitting Multiple Sclerosis (RRMS) patients after 12 months of treatment with Dimethyl Fumarate (DMF). The main questions it aims to answer are: * Can DMF slow or reduce the progression of cognitive dysfunction in RRMS patients? * Can DMF slow the reduction of brain volume in RRMS patients? At baseline visit, RRMS patients undergo extensive neurological examination in which their disability is evaluated by using Expanded Disability Status Scale (EDSS). The efficacy assessments of this study are: 1. The Brief Repeatable Neuropsychological Battery (BRB); 2. Executive functions: Delis-Kaplan Function System (DKEFS) scale - Sorting Test. All RRMS patients undergo MRI: conventional MRI measures (T2-, T1-enhancing and T1-hypointense lesions), global brain atrophy, regional brain atrophy and Diffusion Tensor Imaging (DTI) (GM and thalamus) examinations. Six and 12 months after the baseline visit, the RRMS patients in treatment with DMF undergo the BRB, DKEFS and MRI/DTI study and neurological evaluation (EDSS).

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

* Patients must voluntarily give written informed consent. Patients must read and fully understand the Informed Consent Form (ICF);
* Patient diagnosed with MS according to McDonald criteria;
* Adult patients, males or female patients ≥ 18 years old;
* Relapsing disease course;
* Expanded Disability Status Scale (EDSS) ≤5.5;
* Patients who initiate treatment with DMF 240 mg twice daily according prescribing criteria.

Exclusion Criteria:

* Diagnosis of non-relapsing MS;
* Use of experimental drug or investigational procedure during the study period;
* Pregnancy;
* Severe hepatic impairment;
* Relapse or corticosteroid use within 30 days prior to baseline MRI scan;
* Previous use of alemtuzumab, cladribine, rituximab, or mitoxantrone.

Locations (1)

Messina, Italy