Amyotrophic Lateral Sclerosis and the Innate Immune System

Status: Recruiting
Location: See all (8) locations...
Study Type: Observational
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Denmark
Dept. of Neurology Aarhus Hospital, Nørrebrogade
RECRUITING
Aarhus
Gildhøj Private Hospital
COMPLETED
Brøndby
Clinic of neuroanestesiology, Rigshospitalet Glostrup
RECRUITING
Copenhagen
Dept. of Neurology, Bisbebjerg Hospital
RECRUITING
Copenhagen Nv
Clinic of Neurosurgery, Rigshospitalet
NOT_YET_RECRUITING
Copenhagen Ø
The Dept. og Neurology, Rigshospitalet Glostrup
RECRUITING
Glostrup Municipality
Dept. of Neurology, Odense Hospital
RECRUITING
Odense C
The dept. of Neurology, Roskilde Hospital
RECRUITING
Roskilde
Contact Information
Primary
Anne-Lene Kjældgaard, MD
akja004@regionh.dk
Time Frame
Start Date: 2016-06
Estimated Completion Date: 2026-06
Participants
Target number of participants: 375
Treatments
ALS patients
Patients diagnosed with ALS will be included in this group. Blood and spinal fluid samples will be stored in biobank and later analyzed. A subset of this group (20 ALS patients) will give blood and spinal fluid every 6 months during progression of the disease. A subset of 10 will donate a muscle biopsy.
Control group with patients with other neurological disease
Patients referred to hospital with symptoms of acute or chronic headache.
Neurologically healthy control group
Patients having orthopaedic surgery performed in spinal anaesthesia.
Sponsors
Collaborators: Bispebjerg Hospital, Zealand University Hospital, Odense University Hospital, Aarhus University Hospital
Leads: Rigshospitalet, Denmark

This content was sourced from clinicaltrials.gov