Amyotrophic Lateral Sclerosis and the Innate Immune System
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRigshospitalet, Denmark
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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
Trial population
ALS group: Patients diagnosed with certain or likely ALS Neurological control group: Patients being examined for cronical headache or being referred to hospital to get a lumbar perfusion test performed. Neurologically healthy control group: Clinical study 1: Healty employees from Rigshospitalet Clinical study 2: Neurologically healthy patients having planned orthopaedic surgery performed in spinal anaestesia.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
375 Participants
are grouped into 3 trial groupsGroup A: ALS patients
Group B: Control group with patients with other neurological disease
Group C: Neurologically healthy control group
Trial outcomes
Primary outcomes
1
Complement activity
The complement activity (measured by haemolytic capacity, complement-activation potential and specific mediators) in ALS patients and compared with 2 control groups.
Time frame
0-10 yearSecondary outcomes
1
Subcomponents of the complement cascade
If increased complement activity is found, the amount of the different subcomponents of the complement cascade are measured and compared with the 2 control groups.
Time frame
0-10 years2
Inactivation of the complement system
The effect of inactivation by heat or inhibition of the complement system with anti-complement in the plasma is analyzed by comparing the degree of haemolysis after incubation compared with the test results of the plasma which is not inactivated by heat nor with added anti-complement.
Time frame
0-2 years3
Indirect profiling of inflammatory proteins present in the blood
RNA expression profile of the ALS patients compared with the 2 control groups
Time frame
0-10 years4
Cytokines present in the blood
The cytokines are measured in ALS patients and compared with the 2 control groups.
Time frame
0-10 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Rigshospitalet, Denmark
Lead sponsor
Zealand University Hospital
Collaborator
Bispebjerg Hospital
Collaborator
Aarhus University Hospital
Collaborator
Odense University Hospital
Collaborator
Source ClinicalTrials.gov