Neurofilament Light Chain in Amyotrophic Lateral Sclerosis

NCT ID: NCT06201650

Last Updated: 2024-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-11

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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The aim of this study is to investigate the correlation between the NfL serum concentration and the natural course of the disease, the ALS progression rate as measured by the ALS functional rating scale (ALSFRS-R), and specific phenotypes of ALS. The results of the study will contribute to the assessment of disease progression and the prognosis making of ALS. Furthermore, the performance of NfL as a therapeutic marker of ALS medicines and non-pharmacologic treatment options will be investigated. A systematic analysis of the NfL serum concentration in an extended cohort of ALS patients using the Single Molecule Analysis method (SIMOA) will be performed.

Research objectives comprise:

* Correlation of NfL with disease progression, including duration of ALS disease
* Correlation of NfL with the course of ALS (classic ALS or variants in the motor neuron involvement or the regional propagation patterns)
* Correlation of NfL with the progression rate of ALS

Cohorts on phenotypic variants:

The clinical phenotype of ALS will be differentiated according to the motor neuron involvement or regional propagation patterns of disease onset and clinical course.

ALS variants in relation to motor neuron involvement:

* Typical ALS: clinical features for an affection of the 1st and 2nd motor neurons are present
* Progressive muscular atrophy (PMA): only clinical features for an affection of the 2nd motor neuron are present
* Spastic ALS: predominantly clinical features for an affection of the 1st motor neuron and fewer signs of an affection of the 2nd motor neuron
* Primary lateral sclerosis (PLS): only clinical features for an affection of the 1st motor neuron are present

ALS variants in regional propagation patterns:

* Typical form: paresis of the upper or lower extremities or the bulbar region as well as the spread of the paresis to other regions
* Flail arm syndrome: primary and dominant paresis of the upper extremities and little or delayed spread of the paresis to other regions
* Flail leg syndrome: primary and dominant paresis of the lower extremities and little or delayed spread of the paresis to other regions
* Axial ALS: primary and dominant paresis of the trunk muscles and minor or delayed spread of the paresis to other regions
* Progressive bulbar paralysis: primary and dominant paresis in the bulbar region and slight or delayed spread of the paresis to other regions

Conditions

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Amyotrophic Lateral Sclerosis Motor Neuron Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Neurofilament light chain

Neurofilament light chain as biomarker for amyotrophic lateral sclerosis

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boris Canessa ALS Stiftung

UNKNOWN

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Thomas Meyer, MD

Prof. Dr. Thomas Meyer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thomas Meyer, MD

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

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Medizinische Universität Innsbruck

Innsbruck, , Austria

Site Status NOT_YET_RECRUITING

Vivantes Klinikum Kaulsdorf

Berlin, , Germany

Site Status RECRUITING

Charité Universitätsmedizin Berlin

Berlin, , Germany

Site Status RECRUITING

Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil gGmbH

Bochum, , Germany

Site Status RECRUITING

Universitätsklinikum Bonn

Bonn, , Germany

Site Status RECRUITING

Technische Universität Dresden

Dresden, , Germany

Site Status RECRUITING

Alfried Krupp von Bohlen und Halbach Krankenhaus gGmbH

Essen, , Germany

Site Status RECRUITING

Universitätsklinikum Essen

Essen, , Germany

Site Status RECRUITING

Georg-August-Universität Göttingen Universitätsmedizin Göttingen

Göttingen, , Germany

Site Status RECRUITING

Medizinische Hochschule Hannover

Hanover, , Germany

Site Status RECRUITING

Universitätsklinikum Jena

Jena, , Germany

Site Status RECRUITING

Universität Leipzig

Leipzig, , Germany

Site Status RECRUITING

Universitätsklinikum Schleswig-Holstein

Lübeck, , Germany

Site Status RECRUITING

Universität Heidelberg Medizinische Fakultät Mannheim

Mannheim, , Germany

Site Status RECRUITING

Klinikum rechts der Isar der Technischen Universität München

München, , Germany

Site Status RECRUITING

Westfälische Wilhelms-Universität Münster

Münster, , Germany

Site Status RECRUITING

Universitätsklinikum Regensburg

Regensburg, , Germany

Site Status RECRUITING

Universitätsmedizin Rostock

Rostock, , Germany

Site Status RECRUITING

Universitätsklinikum Ulm

Ulm, , Germany

Site Status RECRUITING

Countries

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Austria Germany

Central Contacts

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Thomas Meyer, MD

Role: CONTACT

004930450560028

Péter Körtvélyessy, MD

Role: CONTACT

004930450560028

Facility Contacts

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Wolfgang Löscher, Prof Dr

Role: primary

Christoph Richter, Dr

Role: primary

Thomas Meyer, Prof Dr

Role: primary

Erma Salkic

Role: backup

Ute Weyen, Dr

Role: primary

Patrick Weydt, PD Dr

Role: primary

René Günther, Dr

Role: primary

Torsten Grehl, Dr

Role: primary

Tim Hagenacker, Prof Dr

Role: primary

Jan Koch, PD Dr

Role: primary

Susanne Petri, Prof Dr

Role: primary

Robert Steinbach, Dr

Role: primary

Petra Baum, PD Dr

Role: primary

Julian Grosskreutz, Prof Dr

Role: primary

Jochen Weishaupt, Prof Dr

Role: primary

Paul Lingor, Prof Dr

Role: primary

Matthias Boentert, PD DR

Role: primary

Zacharias Kohl, PD Dr

Role: primary

Andreas Hermann, Prof. Dr. med. Dr. rer. med.

Role: primary

Johannes Dorst, Prof Dr

Role: primary

Related Links

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https://als-charite.de/

Website of principle investigator

https://canessa-als-stiftung.org/

Website of funding organization

Other Identifiers

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NfL-ALS

Identifier Type: -

Identifier Source: org_study_id

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