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RECRUITINGOBSERVATIONAL

Amyotrophic Lateral Sclerosis and the Innate Immune System

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

Amyotrophic Lateral Sclerosis (ALS) is an aggressive, deadly disease. ALS leads to destruction of the neural pathways which control the conscious movements of the muscles. This destruction leads to muscular dystrophy with increasing difficulties in moving, breathing, swallowing, and speaking. In the last phase of an ALS patient's life it is necessary with respiratory therapy in order to breathe. In average an ALS patient lives 3 years from the time he or she gets the diagnose. The cause of the disease is still unknown and there is currently no treatment which can stop the progression of the disease. Former clinical studies have indicated that the innate immune system and in particular the complement system plays a significant role in the progression of ALS. The complement system, which is activated in cascades, is part of the innate system but participates in the innate as well as the acquired immune system. Former clinical trials have been characterized by limited knowledge about both the complement system as well as to how it is measured. Today it is possible to measure directly on the different components of the complement system and to understand its contribution to the overall immune response. It is also possible today to detect defects of the complement system. All these progressions are the foundation for this project which is carried out in close cooperation with one of the world's leading researchers in the complement system, professor Peter Garred from Rigshospitalet. The aim is to make a national research project about ALS in order to investigate the role of the innate immune system, and especially the complement system, in patients with ALS. In the long term the hope is, that this will lead the way to a targeted and effective medical treatment to the people affected by this grave disease.

Who May Be Eligible (Plain English)

Who May Qualify: - For ALS group:Diagnosed with the diagnose category "certain ALS" or "likely ALS according to the El Escorial rev. diagnose criteria - For Neurological control group: Referred to neurological department to be examined for acute or chronic headache or referred to get a lumbar perfusion test performed. Who Should NOT Join This Trial: - For all groups (Clinical study 2-3): permanent contraindication for having a lumbar puncture performed - For Neurological control group: Known with chronic inflammatory disease or autoimmune conditions (where your immune system attacks your own body). - For healthy control group (clinical study 1): Known with any disease - For healthy control group (clinical study 1): Taking daily medication - For Neurologically healthy control group (Clinical study 2): Known with neurological disease - For Neurologically healthy control group (Clinical study 2): Known with chronic inflammatory disease or autoimmune conditions (where your immune system attacks your own body). Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * For ALS group:Diagnosed with the diagnose category "certain ALS" or "likely ALS according to the El Escorial rev. diagnose criteria * For Neurological control group: Referred to neurological department to be examined for acute or chronic headache or referred to get a lumbar perfusion test performed. Exclusion Criteria: * For all groups (Clinical study 2-3): permanent contraindication for having a lumbar puncture performed * For Neurological control group: Known with chronic inflammatory disease or autoimmune disease. * For healthy control group (clinical study 1): Known with any disease * For healthy control group (clinical study 1): Taking daily medication * For Neurologically healthy control group (Clinical study 2): Known with neurological disease * For Neurologically healthy control group (Clinical study 2): Known with chronic inflammatory disease or autoimmune disease.

Locations (8)

Dept. of Neurology Aarhus Hospital, Nørrebrogade
Aarhus, Denmark
Gildhøj Private Hospital
Brøndby, Denmark
Clinic of neuroanestesiology, Rigshospitalet Glostrup
Copenhagen, Denmark
Dept. of Neurology, Bisbebjerg Hospital
Copenhagen NV, Denmark
Clinic of Neurosurgery, Rigshospitalet
Copenhagen Ø, Denmark
The Dept. og Neurology, Rigshospitalet Glostrup
Glostrup Municipality, Denmark
Dept. of Neurology, Odense Hospital
Odense C, Denmark
The dept. of Neurology, Roskilde Hospital
Roskilde, Denmark