Amyotrophic Lateral Sclerosis Clinical Trial
Official title:
Amyotrophic Lateral Sclerosis and the Innate Immune System
Verified date | October 2017 |
Source | Rigshospitalet, Denmark |
Contact | Anne-Lene Kjældgaard, MD |
akja004[@]regionh.dk | |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Recruiting |
Enrollment | 375 |
Est. completion date | June 2026 |
Est. primary completion date | June 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Denmark | 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 | |
Denmark | Dept. of Neurology, Odense Hospital | Odense C | |
Denmark | The dept. of Neurology, Roskilde Hospital | Roskilde |
Lead Sponsor | Collaborator |
---|---|
Rigshospitalet, Denmark | Aarhus University Hospital, Bispebjerg Hospital, Odense University Hospital, Zealand University Hospital |
Denmark,
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* Note: There are 36 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Complement activity | The complement activity (measured by haemolytic capacity, complement-activation potential and specific mediators) in ALS patients and compared with 2 control groups. | 0-10 year | |
Secondary | 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. | 0-10 years | |
Secondary | 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. | 0-2 years | |
Secondary | Indirect profiling of inflammatory proteins present in the blood | RNA expression profile of the ALS patients compared with the 2 control groups | 0-10 years | |
Secondary | Cytokines present in the blood | The cytokines are measured in ALS patients and compared with the 2 control groups. | 0-10 years | |
Secondary | Acut phase reactants | The acute phase reactants are measured in ALS patients and compared with the 2 control groups. | 0-10 years | |
Secondary | Complement activity in the neuromuscular junctions of ALS patients. (Clinical trial 4) | The amount of complement deposition as well as complement activity in the neuromuscular junctions are described quantitatively as well as qualitatively | 0-3 years | |
Secondary | Quantitatively and qualitatively description of ALS muscle fibers. | The muscle fibres are described quantitatively as well as qualitatively and compared historically collected material of healthy muscle fibers. | 0-3 years | |
Secondary | Regression analysis | The immune response of the ALS patients is analyzed as a function of sex, age, subtype of disease, stage of disease, severity of disease, duration of disease, present smoking, alcohol consumption, present use of medicine (including riluzole). The regression analysis will be compared when possible with the 2 control groups (sex, age, smoking, alcohol consumption, use of medicine). | 0-10 years |
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