Assessing neurofilament light chain levels in ALS patients
Performance of Serum Neurofilament Light Chain in a Wide Spectrum of Clinical Courses of Amyotrophic Lateral Sclerosis - a Cross-sectional and Longitudinal Multicenter Study
This study is testing if measuring a protein called neurofilament light chain in the blood can help doctors understand how ALS is progressing in patients and if it could be useful for future treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Charite University, Berlin, Germany Academic / other |
| Locations | 19 sites (Innsbruck and 18 other locations) |
| Trial ID | NCT06201650 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the serum concentration of neurofilament light chain (NfL) in patients with amyotrophic lateral sclerosis (ALS) to understand its correlation with disease progression, duration, and specific phenotypes of ALS. Utilizing the Single Molecule Analysis method (SIMOA), the study will analyze data from a cohort of 3,000 ALS patients across multiple centers. The research aims to establish NfL as a potential therapeutic biomarker for ALS treatments and to enhance prognostic assessments based on ALS functional rating scales.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older diagnosed with amyotrophic lateral sclerosis or its specific forms.
Not a fit: Patients who are unwilling to consent to blood collection or share pseudonymized medical data may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a reliable biomarker for monitoring ALS progression and tailoring treatment strategies.
How similar studies have performed: Previous studies have shown promise in using neurofilament light chains as biomarkers in neurodegenerative diseases, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of amyotrophic lateral sclerosis including specific forms * Patient's informed consent to participate in this study * Minimum age of 18 years * Willingness for blood collection Exclusion Criteria: * Unwillingness to store and share pseudonymized medical data collected in the study * Evaluation by the investigator, which excludes participation
Where this trial is running
Innsbruck and 18 other locations
- Medizinische Universität Innsbruck — Innsbruck, Austria (Not_yet_recruiting)
- Vivantes Klinikum Kaulsdorf — Berlin, Germany (Recruiting)
- Charité Universitätsmedizin Berlin — Berlin, Germany (Recruiting)
- Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil gGmbH — Bochum, Germany (Recruiting)
- Universitätsklinikum Bonn — Bonn, Germany (Recruiting)
- Technische Universität Dresden — Dresden, Germany (Recruiting)
- Alfried Krupp von Bohlen und Halbach Krankenhaus gGmbH — Essen, Germany (Recruiting)
- Universitätsklinikum Essen — Essen, Germany (Recruiting)
- Georg-August-Universität Göttingen Universitätsmedizin Göttingen — Göttingen, Germany (Recruiting)
- Medizinische Hochschule Hannover — Hannover, Germany (Recruiting)
- Universitätsklinikum Jena — Jena, Germany (Recruiting)
- Universität Leipzig — Leipzig, Germany (Recruiting)
- Universitätsklinikum Schleswig-Holstein — Lübeck, Germany (Recruiting)
- Universität Heidelberg Medizinische Fakultät Mannheim — Mannheim, Germany (Recruiting)
- Klinikum rechts der Isar der Technischen Universität München — München, Germany (Recruiting)
- Westfälische Wilhelms-Universität Münster — Münster, Germany (Recruiting)
- Universitätsklinikum Regensburg — Regensburg, Germany (Recruiting)
- Universitätsmedizin Rostock — Rostock, Germany (Recruiting)
- Universitätsklinikum Ulm — Ulm, Germany (Recruiting)
Study contacts
- Principal investigator: Thomas Meyer, MD — Charite University, Berlin, Germany
- Study coordinator: Thomas Meyer, MD
- Email: thomas.meyer@charite.de
- Phone: 004930450560028
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.