French-German Cohort Study to Determine Factors Associated With Weight Loss in Amyotrophic Lateral Sclerosis (FG-CoALS)

November 18, 2023 updated by: University Hospital, Limoges

Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease. Studies have shown the importance of weight loss at the time of diagnosis and during the progression of the disease. However, the pathophysiological mechanisms behind weight loss remain unknown. Identifying these mechanisms could make it possible to propose an effective therapeutic strategy against weight loss for ALS patients, which could improve their survival and quality of life. In this context, the investigators are proposing an innovative multidisciplinary project aimed at structuring a large Franco-German cohort to identify the markers associated with weight loss in ALS.

Participants will undergo high quality standard care for ALS patients. In addition, participants will be asked to respond different questionnaires and blood samples will be taken for analysis to identify biological markers.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

ALS is the most frequent adult onset motor neuron disease and is highly variable in terms of clinical features, genetics, and neuropathology. A large body of evidence has demonstrated the importance of weight loss at the time of diagnosis and during disease progression. Weight loss affects between one and two-thirds of patients and is adversely associated with survival. High caloric nutrition was able to slow weight loss and prolong survival in fast progressing ALS patients. Pathophysiological mechanisms underlying weight loss remain unknown because high-quality cohort data collecting clinical features, genetics, omics, and imaging related to the metabolic and disease status of patients are lacking. The investigators hypothesize that weight loss in ALS patients is biologically driven through specific pathways. The investigators propose an innovative and ambitious multidisciplinary project to structure a large French-German cohort to identify markers associated with weight loss. The investigators aim at identifying the biological correlates of weight loss to disentangle the mechanistic basis of this critical symptom and to determine clinical and biological profiles along with their impact on disease progression and survival.

Study Type

Interventional

Enrollment (Estimated)

1000

Phase

  • Not Applicable

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 Backup

Study Locations

  • France
      • Limoges, France, 87042
        • Limoges university hospital
        • Contact:
          • Philippe COURATIER, Pr
          • Phone Number: 05 55 05 15 69
        • Contact:

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Incident cases included at the time of diagnosis with a definite, probable, probable laboratory-supported, or possible ALS according to El Escorial revised criteria and Gold Coast criteria for early diagnosis.
  • Incident ALS cases identified and followed-up in the participant ALS & Other Motor Neuron Diseases Referral Centres: seven in France and two in Germany.
  • Patients who signed the informed consent form.
  • Adults aged >18 years old

Exclusion Criteria:

  • Inability to understand the requirements of the protocol.
  • Cognitive inability to sign and comprehend the informed consent form.
  • Patients who will not accept Riluzole therapy during their follow-up.

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

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: ALL participants

ALS patients will be stratified in 4 groups according to the weight loss percentage: a) no weight loss; b) <5% of weight loss; c) 5-10% of weight loss; d) >10% of weight loss.

In order to identify the genomic, metabolomic, metabolic, neurofilaments, and inflammation markers associated to weight loss.
Other: Blood sample
Blood sample will be taken to identify Genomic, metabolomic, metabolic, neurofilaments, and inflammation markers associated to weight loss

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival
Time Frame: every 6 month until 18 months of follow up
Survival evaluated in month since diagnosis
every 6 month until 18 months of follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease progression (ALSFRS-R slope)
Time Frame: every 6 month until 18 months of follow up
The ALSFRS-R is a validated rating instrument for monitoring the progression of disability in patients with amyotrophic lateral sclerosis (ALS)
every 6 month until 18 months of follow up

Collaborators and Investigators

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

Sponsor

University Hospital, Limoges

Collaborators

National Research Agency, France
Institut du Cerveau et de la Moelle épinière
Centre de Recherche en biomédecine de Strasbourg INSERM UMR-S1118
Institut National de la Santé et de la Recherche Médical - délégation Grand Ouest INSERM U1253
Klinik für Neurologie, Universitäts- und Rehabilitationskliniken Ulm (RKU)
Centre de Données Cliniques et de Recherche CDCR
UMR Inserm U1253-IBRain-Neurogénétique et Physiopathologie Neuronale
France Cohorte

Investigators

  • Principal Investigator: Philippe COURATIER, University Hospital, Limoges

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 (Estimated)

January 20, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

March 31, 2028

Study Registration Dates

First Submitted

July 12, 2023

First Submitted That Met QC Criteria

November 18, 2023

First Posted (Actual)

November 28, 2023

Study Record Updates

Last Update Posted (Actual)

November 28, 2023

Last Update Submitted That Met QC Criteria

November 18, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 87RI21_0053

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The FG-CoALS project is part of the 11 cohorts of rare diseases of the National Research Agency (ANR) in France. The ANR has entrusted "France Cohortes" with the task of supporting 11 projects on rare diseases.

With the implementation of a FAIR approach right from the data collection phase, the national research infrastructure dedicated to "France cohortes" will contribute to the management, dissemination and re-use of data, while guaranteeing the strict protection of the data.

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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