Actively Recruiting
Amyotrophic Lateral Sclerosis and the Innate Immune System
Led by Rigshospitalet, Denmark · Updated on 2017-10-06
375
Participants Needed
8
Research Sites
521 weeks
Total Duration
On this page
Sponsors
R
Rigshospitalet, Denmark
Lead Sponsor
Z
Zealand University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Amyotrophic Lateral Sclerosis and the Innate Immune System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with "certain ALS" or "likely ALS" according to the El Escorial revised criteria (for ALS group)
- Referred to neurological department for evaluation of acute or chronic headache or for lumbar puncture (neurological control group)
You will not qualify if you...
- Permanent contraindication for lumbar puncture (all groups for Clinical study 2 and 3)
- Known chronic inflammatory or autoimmune disease (neurological control group)
- Known with any disease (healthy control group for Clinical study 1)
- Taking daily medication (healthy control group for Clinical study 1)
- Known neurological disease (neurologically healthy control group for Clinical study 2)
- Known chronic inflammatory or autoimmune disease (neurologically healthy control group for Clinical study 2)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Dept. of Neurology Aarhus Hospital, Nørrebrogade
Aarhus, Denmark, 8000
Actively Recruiting
2
Gildhøj Private Hospital
Brøndby, Denmark, 2605
Completed
3
Clinic of neuroanestesiology, Rigshospitalet Glostrup
Copenhagen, Denmark, 2600
Actively Recruiting
4
Dept. of Neurology, Bisbebjerg Hospital
Copenhagen NV, Denmark, 2400
Actively Recruiting
5
Clinic of Neurosurgery, Rigshospitalet
Copenhagen Ø, Denmark, 2100
Not Yet Recruiting
6
The Dept. og Neurology, Rigshospitalet Glostrup
Glostrup Municipality, Denmark, 2600
Actively Recruiting
7
Dept. of Neurology, Odense Hospital
Odense C, Denmark, 5000
Actively Recruiting
8
The dept. of Neurology, Roskilde Hospital
Roskilde, Denmark, 4000
Actively Recruiting
Research Team
A
Anne-Lene Kjældgaard, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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