Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
ID02869048

Amyotrophic Lateral Sclerosis and the Innate Immune System

Led by Rigshospitalet, Denmark · Updated on 2017-10-06

375

Participants Needed

8

Research Sites

N/A

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 a severe, progressive disease that destroys nerve pathways controlling muscle movements, leading to difficulties in moving, breathing, swallowing, and speaking. The cause of ALS is unknown, and there is currently no treatment that stops its progression. Researchers are investigating the role of the innate immune system, especially the complement system, in the development and progression of ALS, aiming to better understand the disease and potentially guide future treatments. This project includes four clinical trials involving ALS patients, neurological controls, and healthy volunteers. Blood and spinal fluid samples are collected and stored in a biobank for analysis of complement activity and immune system components. Some ALS patients provide samples every six months to track disease progression, and a subset donates muscle biopsies to study complement activity in neuromuscular junctions. The trials use modern techniques to examine immune responses and their relation to ALS symptoms. Participants will undergo blood sampling, spinal fluid collection, and in some cases, muscle biopsies. Researchers measure complement activity, inflammatory proteins, cytokines, and muscle fiber characteristics. The study includes repeated assessments over time for some patients. Results will be analyzed statistically and published. The research aims to improve understanding of ALS pathophysiology, which may help develop targeted treatments in the future. Participation involves regular visits and sample collections over several years.

CONDITIONS

Brief Title

Amyotrophic Lateral Sclerosis and the Innate Immune System

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with "certain ALS" or "likely ALS" according to El Escorial revised criteria for the ALS group
  • Referred to neurological department for acute or chronic headache or lumbar puncture for the neurological control group
  • Adults aged 18 years or older
Not Eligible

You will not qualify if you...

  • Permanent contraindication to lumbar puncture for all groups in Clinical Studies 2 and 3
  • Known chronic inflammatory or autoimmune disease for the neurological control group
  • Any known disease for the healthy control group in Clinical Study 1
  • Taking daily medication for the healthy control group in Clinical Study 1
  • Known neurological disease for the neurologically healthy control group in Clinical Study 2
  • Known chronic inflammatory or autoimmune disease for the neurologically healthy control group in Clinical Study 2

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Single timepoint with possible repeat sampling

Participants provide blood and spinal fluid samples which are collected and stored in a research biobank for analysis of the complement system and immune markers.

1 visit (in-person) for sample collection

Long-term Monitoring

Duration - Repeated every 6 months over up to 10 years

A subset of participants with ALS provide blood and spinal fluid samples every six months to monitor complement system activity as the disease progresses.

Visits every 6 months

Sample Collection

Duration - Single timepoint with analysis over up to 3 years

A smaller subset of ALS participants undergo muscle biopsies to analyze neuromuscular junction complement activity and muscle fiber pathology.

1 visit (in-person) for biopsy

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

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Research Team

A

Anne-Lene Kjældgaard, MD

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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Published Research Related To This Trial

Cytotoxic activity in the plasma of amyotrophic lateral sclerosis (ALS) patients against normal erythrocytes. Quantitative determinations.

S Conradi, L O Ronnevi

https://pubmed.ncbi.nlm.nih.gov/4009202