Neurofilament Light Chain in Amyotrophic Lateral Sclerosis

NCT06201650 | Unknown

• 1 other identifier: NfL-ALS
• Study Type: observational
• Target: 3,000
• Locations: 2 countries
• Sites: 19

Brief Summary

This study assesses the performance of serum neurofilament light chain (sNfL) in amyotrophic lateral sclerosis (ALS) in a wide range of disease courses, in terms of ALS progression, disease duration, and tracheostomy invasive ventilation (TIV). The aim of the research project is to investigate the correlation between NfL serum concentration and the natural course of the disease, the ALS progression rate, and specific phenotypes of ALS. Furthermore, the performance of NfL as a therapeutic biomarker will be studied. A systematic analysis of the NfL serum concentration in a cohort of 3,000 ALS patients using the Single Molecule Analysis method (SIMOA) will be performed. This analysis is carried out as a multi-center study.

Conditions

Amyotrophic Lateral Sclerosis; Motor Neuron Disease

Keywords

ALS; Amyotrophic lateral sclerosis; Neurofilament light chain; NfL; ALS Funktional Rating Scale; Progression; biomarker; treatment marker; therapeutic marker

Outcome Measures

Primary Outcomes (3)

• correlation of serum neurofilament light chain to ALS progression

  correlation of serum neurofilament light chain (NfL) with the ALS progression rate as measured by the revised form of the ALS function rating scale (ALSFRS-R)

  2020-2024

• correlation of serum neurofilament light chain with ALS phenotypes

  correlation of serum neurofilament light chain with ALS phenotypes in terms of type of onset and clinical variants including progressive muscle atrophy, primary lateral sclerosis, flail-arm syndrome, flail-leg syndrome and other phenotypes

  2020-2024

• correlation of serum neurofilament light chain with ALS treatment options

  correlation of serum neurofilament light chain to ALS interventions such as treatment with tofersen and other medicines

  2020-2024

Secondary Outcomes (1)

• correlation of serum neurofilament light chain with non-pharmacologic ALS interventions

  2022-2024

Interventions

Neurofilament light chain DIAGNOSTIC_TEST

Neurofilament light chain as biomarker for amyotrophic lateral sclerosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with clinical diagnosis of amyotrophic lateral sclerosis

You may qualify if:

• 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

You may not qualify if:

• Unwillingness to store and share pseudonymized medical data collected in the study
• Evaluation by the investigator, which excludes participation

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Boris Canessa ALS Stiftung: collaborator

Study Sites (19)

Medizinische Universität Innsbruck

Innsbruck, 6020, Austria

NOT YET RECRUITING

Vivantes Klinikum Kaulsdorf

Berlin, 12621, Germany

RECRUITING

Charité Universitätsmedizin Berlin

Berlin, 13353, Germany

RECRUITING

Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil gGmbH

Bochum, 44789, Germany

RECRUITING

Universitätsklinikum Bonn

Bonn, 53127, Germany

RECRUITING

Technische Universität Dresden

Dresden, 01062, Germany

RECRUITING

Alfried Krupp von Bohlen und Halbach Krankenhaus gGmbH

Essen, 45131, Germany

RECRUITING

Universitätsklinikum Essen

Essen, 45147, Germany

RECRUITING

Georg-August-Universität Göttingen Universitätsmedizin Göttingen

Göttingen, 37075, Germany

RECRUITING

Medizinische Hochschule Hannover

Hanover, 30625, Germany

RECRUITING

Universitätsklinikum Jena

Jena, 07743, Germany

RECRUITING

Universität Leipzig

Leipzig, 04103, Germany

RECRUITING

Universitätsklinikum Schleswig-Holstein

Lübeck, 23538, Germany

RECRUITING

Universität Heidelberg Medizinische Fakultät Mannheim

Mannheim, 68167, Germany

RECRUITING

Klinikum rechts der Isar der Technischen Universität München

München, 81675, Germany

RECRUITING

Westfälische Wilhelms-Universität Münster

Münster, 48149, Germany

RECRUITING

Universitätsklinikum Regensburg

Regensburg, 93053, Germany

RECRUITING

Universitätsmedizin Rostock

Rostock, 18057, Germany

RECRUITING

Universitätsklinikum Ulm

Ulm, 89081, Germany

RECRUITING

Related Links

• Website of principle investigator
• Website of funding organization

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis; Motor Neuron Disease; Charcot-Marie-Tooth disease, Type 1F; Disease Progression

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Thomas Meyer, MD

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Meyer, MD

CONTACT

004930450560028; thomas.meyer@charite.de

Péter Körtvélyessy, MD

CONTACT

004930450560028; peter.koertvelyessy@charite.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Thomas Meyer

Study Record Dates

• First Submitted: April 1, 2023
• First Posted: January 11, 2024
• Study Start: November 11, 2020
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 11, 2024

Record last verified: 2023-12

Locations

DE (18); AU (1)