Physical and Cognitive Performance During the Two First Years of Lemtrada Treatment

University of Aarhus

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Drug: Alemtuzumab

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03806387

MS_Improve

Details and patient eligibility

About

Multiple Sclerosis (MS) is a chronic autoimmune neurodegenerative disease of the central nervous system (CNS). The symptoms of MS are wide-ranging, but patients perceive loss of physical function (gait) and cognitive function as the most critical consequences of the disease. Moreover, recent studies have shown that already at early disease stages functional impairments are present.

One of the more recent approved medical treatments for MS patients is Alemtuzumab (product name Lemtrada), a humanized monoclonal antibody targeting CD52 cells, that depletes and repopulates B lymphocytes and T lymphocytes, causing sustained changes in the adaptive immunity. In 2013 and 2014 Alemtuzumab was approved in EU and USA, respectively.

With the exception of the MS Functional Composite z-score, the previous clinical studies investigating the effect of Alemtuzumab have exclusively focused on clinical parameters such as MRI indications of disease activity (accumulation of lesion, total and regional brain atrophy etc.), relapse-rates, changes in 'expanded disability status scale' (EDSS) and side-effects/adverse events. However, no previous studies have performed in depth monitoring on how physical or cognitive performance are affected following initiation of treatment with Alemtuzumab despite the paramount importance to patients.

The primary purpose of this project is to monitor the changes in physical performance during the first two years of treatment with Alemtuzumab in a well characterised Danish cohort of people with relapsing-remitting MS. A secondary purpose is to monitor the impact of Alemtuzumab treatment on cognition during the first two years of treatment.

Enrollment: 17 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical definite Multiple Sclerosis diagnosis according to the McDonald criteria
• About to commence alemtuzumab (Lemtrada) treatment
• Expanded Disability Status Scale (EDSS) ≤ 5.5
• Signed informed consent

Exclusion criteria

• Co-morbidities that prevent participation in the project (dementia, serious cognitive disorders etc.)