Investigating the role of the innate immune system in ALS

Amyotrophic Lateral Sclerosis and the Innate Immune System

This study is trying to see how the body's immune system affects the progression of ALS by collecting samples from ALS patients and healthy individuals.

Quick facts

• Study type: Observational
• Enrollment: 375 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Rigshospitalet, Denmark (other)
• Drugs / interventions: equlizumab
• Locations: 8 sites (Aarhus and 7 other locations)
• Trial ID: NCT02869048 on ClinicalTrials.gov

What this trial studies

This observational study focuses on understanding the role of the innate immune system, particularly the complement system, in the progression of Amyotrophic Lateral Sclerosis (ALS). It aims to gather biological specimens from patients diagnosed with ALS and control groups to analyze the activation of complement proteins. By examining these immune responses, the study seeks to uncover potential mechanisms behind ALS and inform future treatment strategies. The research is conducted across multiple hospitals in Denmark, involving both ALS patients and neurological controls.

Who should consider this trial

Good fit: Ideal candidates include individuals diagnosed with 'certain ALS' or 'likely ALS' according to established diagnostic criteria.

Not a fit: Patients with chronic inflammatory diseases, autoimmune diseases, or those who are neurologically healthy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a better understanding of ALS and pave the way for new therapeutic approaches.

How similar studies have performed: Previous studies have suggested a link between the complement system and ALS, indicating that this approach may yield valuable insights.

Eligibility criteria

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.

Where this trial is running

Aarhus and 7 other locations

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

Study contacts

• Principal investigator: Anne-Lene Kjældgaard, MD — Clinic of Neuroanaestesiology, Rigshospitalet Glostrup
• Study coordinator: Anne-Lene Kjældgaard, MD

Conditions: Amyotrophic Lateral Sclerosis, Neurodegenerative Disease, Motor Neuron Disease, Biological Specimen Banks, Innate Immunity, Clinical Study, Complement system proteins, Amyotrophic lateral sclerosis