Neurofilament Light Chain in Amyotrophic Lateral Sclerosis (NfL-ALS)

December 31, 2023 updated by: Thomas Meyer, MD, Charite University, Berlin, Germany

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 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Austria
      • Innsbruck, Austria, 6020
        • Not yet recruiting
        • Medizinische Universitat Innsbruck
        • Contact:
          • Wolfgang Löscher, Prof Dr
        • Principal Investigator:
          • Wolfgang Löscher, Prof Dr
  • Germany
      • Berlin, Germany, 13353
      • Berlin, Germany, 12621
        • Recruiting
        • Vivantes Klinikum Kaulsdorf
        • Contact:
          • Christoph Richter, Dr
        • Principal Investigator:
          • Christoph Richter, Dr
      • Bochum, Germany, 44789
        • Recruiting
        • Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil gGmbH
        • Contact:
          • Ute Weyen, Dr
        • Principal Investigator:
          • Ute Weyen, Dr
      • Bonn, Germany, 53127
        • Recruiting
        • Universitätsklinikum Bonn
        • Contact:
          • Patrick Weydt, PD Dr
        • Principal Investigator:
          • Patrick Weydt, PD Dr
      • Dresden, Germany, 01062
        • Recruiting
        • Technische Universität Dresden
        • Contact:
          • René Günther, Dr
        • Principal Investigator:
          • René Günther, Dr
      • Essen, Germany, 45147
        • Recruiting
        • Universitatsklinikum Essen
        • Contact:
          • Tim Hagenacker, Prof Dr
        • Principal Investigator:
          • Tim Hagenacker, Prof Dr
      • Essen, Germany, 45131
        • Recruiting
        • Alfried Krupp von Bohlen und Halbach Krankenhaus gGmbH
        • Contact:
          • Torsten Grehl, Dr
        • Principal Investigator:
          • Torsten Grehl, Dr
      • Göttingen, Germany, 37075
        • Recruiting
        • Georg-August-Universität Göttingen Universitätsmedizin Göttingen
        • Contact:
          • Jan Koch, PD Dr
        • Principal Investigator:
          • Jan Koch, PD Dr
      • Hannover, Germany, 30625
        • Recruiting
        • Medizinische Hochschule Hannover
        • Contact:
          • Susanne Petri, Prof Dr
        • Principal Investigator:
          • Susanne Petri, Prof Dr
      • Jena, Germany, 07743
        • Recruiting
        • Universitatsklinikum Jena
        • Contact:
          • Robert Steinbach, Dr
      • Leipzig, Germany, 04103
        • Recruiting
        • Universität Leipzig
        • Contact:
          • Petra Baum, PD Dr
        • Principal Investigator:
          • Petra Baum, PD Dr
      • Lübeck, Germany, 23538
        • Recruiting
        • Universitätsklinikum Schleswig-Holstein
        • Contact:
          • Julian Grosskreutz, Prof Dr
        • Principal Investigator:
          • Julian Grosskreutz, Prof Dr
      • Mannheim, Germany, 68167
        • Recruiting
        • Universität Heidelberg Medizinische Fakultät Mannheim
        • Contact:
          • Jochen Weishaupt, Prof Dr
        • Principal Investigator:
          • Jochen Weishaupt, Prof Dr
      • München, Germany, 81675
        • Recruiting
        • Klinikum Rechts Der Isar Der Technischen Universität München
        • Contact:
          • Paul Lingor, Prof Dr
        • Principal Investigator:
          • Paul Lingor, Prof Dr
      • Münster, Germany, 48149
        • Recruiting
        • Westfälische Wilhelms-Universität Münster
        • Contact:
          • Matthias Boentert, PD DR
        • Principal Investigator:
          • Matthias Boentert, PD Dr
      • Regensburg, Germany, 93053
        • Recruiting
        • Universitätsklinikum Regensburg
        • Contact:
          • Zacharias Kohl, PD Dr
        • Principal Investigator:
          • Zacharias Kohl, PD Dr
      • Rostock, Germany, 18057
        • Recruiting
        • Universitätsmedizin Rostock
        • Contact:
          • Andreas Hermann, Prof. Dr. med. Dr. rer. med.
        • Principal Investigator:
          • Andreas Hermann, Prof Dr Dr
      • Ulm, Germany, 89081
        • Recruiting
        • Universitatsklinikum Ulm
        • Contact:
          • Johannes Dorst, Prof Dr
        • Principal Investigator:
          • Johannes Dorst, Prof Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

patients with clinical diagnosis of amyotrophic lateral sclerosis

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
correlation of serum neurofilament light chain to ALS progression
Time Frame: 2020-2024
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
Time Frame: 2020-2024
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
Time Frame: 2020-2024
correlation of serum neurofilament light chain to ALS interventions such as treatment with tofersen and other medicines
2020-2024

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
correlation of serum neurofilament light chain with non-pharmacologic ALS interventions
Time Frame: 2022-2024
correlation of serum neurofilament light chain with non-pharmacologic ALS interventions including nutrition or ventilation treatment
2022-2024

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Charite University, Berlin, Germany

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Boris Canessa ALS Stiftung

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Thomas Meyer, MD, Charite University, Berlin, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 11, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 1, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 31, 2023

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 11, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 11, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 31, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NfL-ALS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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