Physical and Cognitive Performance During the Two First Years of Lemtrada Treatment - a Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Six minute walking test (6MWT)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Co-morbidities that prevent participation in the project (dementia, serious cognitive disorders etc.)
结局指标
主要结局
Six minute walking test (6MWT)
时间窗: From baseline to 24 months
Change in maximal walking distance covered in 6 minutes
次要结局
- Six minute walking test (6MWT)(From baseline to 3 months, 6 months, and 12 months)
- Timed 25 foot walk (T25FWT)(From baseline to 3 months, 6 months, 12 months, and 24 months)
- 5 times sit to stand test (5STS)(From baseline to 3 months, 6 months, 12 months, and 24 months)
- Timed Up and Go (TUG)(From baseline to 3 months, 6 months, 12 months, and 24 months)
- Stair Climbing test(From baseline to 3 months, 6 months, 12 months, and 24 months)
- Six Spot Step Test (SSST)(From baseline to 3 months, 6 months, 12 months, and 24 months)
- Maximal oxygen uptake (VO2 max)(From baseline to 3 months, 6 months, 12 months, and 24 months)
- Maximal muscle strength(From baseline to 3 months, 6 months, 12 months, and 24 months)
- Neuromuscular activation(From baseline to 3 months, 6 months, 12 months, and 24 months)
- Body composition - limb lean mass(From baseline to 3 months, 6 months, 12 months, and 24 months)
- Body composition - limb fat mass(From baseline to 3 months, 6 months, 12 months, and 24 months)
- Body composition - whole body lean mass(From baseline to 3 months, 6 months, 12 months, and 24 months)
- Body composition - whole body fat mass(From baseline to 3 months, 6 months, 12 months, and 24 months)
- Selective Reminding Test (SRT)(From baseline to 3 months, 6 months, 12 months, and 24 months)
- Symbol Digit Modalities Test (SDMT)(From baseline to 3 months, 6 months, 12 months, and 24 months)
- Physical activity(From baseline to 3 months, 6 months, 12 months, and 24 months)
- Clinical Severity of Disease(From baseline to 3 months, 6 months, 12 months, and 24 months)
- Relapse frequency(From baseline to 3 months, 6 months, 12 months, and 24 months)
- 12-item Multiple Sclerosis Walking Scale (MSWS-12)(From baseline to 3 months, 6 months, 12 months, and 24 months)
- Modified Fatigue Impact Scale (MFIS)(From baseline to 3 months, 6 months, 12 months, and 24 months)
- Multiple Sclerosis Impact Scale (MSIS-29)(From baseline to 3 months, 6 months, 12 months, and 24 months)
- Hospital Anxiety and Depression Scale (HADS)(From baseline to 3 months, 6 months, 12 months, and 24 months)