FG-CoALS

Franco-German cohort study on factors associated with weight loss in amyotrophic lateral sclerosis (ALS)

Background

Amyotrophic lateral sclerosis (ALS) is the most common motor neuron disease in adults. It is highly variable in terms of clinical presentation, genetics, and neuropathology. ALS is a fatal disease that progresses inexorably within a few years of onset.

Weight loss in ALS

Extensive data have demonstrated the importance of weight loss at diagnosis and during disease progression. Recent studies have shown that weight loss is a central mechanism, occurring very early—even before motor symptoms appear.

Between one-third and two-thirds of patients experience weight loss, which is negatively associated with survival. High-calorie diets have been shown to slow weight loss and extend survival in patients with rapidly progressing ALS.

However, the pathophysiological mechanisms underlying weight loss remain unknown. Identifying these mechanisms could lead to effective therapeutic strategies to combat weight loss, thereby improving survival and quality of life in ALS patients.

FG-CoALS is an innovative, multidisciplinary project aiming to establish a large Franco-German cohort to identify markers associated with weight loss in ALS.

Study objectives

The primary objective of this study is to identify biological, genetic, and imaging markers associated with weight loss in ALS patients, and to analyze their correlations with clinical presentation.

French data from the project will be transferred to the secure France Cohortes information system, ensuring information sharing with researchers at both national and international levels, in accordance with FAIR principles.

Study design

This is an academic, prospective, multicenter study including 7 ALS reference centers in France and 2 in Germany.

  • At least 1,000 patients will be included.
  • A sub-cohort of 400 patients will undergo additional investigations.
  • Patients will be stratified into four groups according to their percentage of weight loss:
    1. No weight loss
    2. <5% weight loss
    3. 5–10% weight loss
    4. 10% weight loss

Each patient may be included in both the main cohort and the sub-cohort.

Eligibility

  • Inclusion: Any new patient diagnosed with ALS, aged over 18, managed and followed at one of the 9 participating ALS centers in France and Germany.
  • Exclusion: Patients with significant cognitive impairment or those who refuse riluzole treatment.
  • All participants must be covered by a national health insurance scheme.

FG-CoALS Consortium

ALS and motor neuron disease reference centers (France):

  • Prof. Philippe COURATIER – CHU Limoges
  • Prof. Gaelle BRUNETEAU – Pitié-Salpêtrière Hospital Group
  • Dr. Pierre-François PRADAT – Pitié-Salpêtrière Hospital Group
  • Prof. Philippe CORCIA – CHRU Tours
  • Dr. Véronique DANEL BRUNAUD – CHU Lille
  • Dr. Marie-Hélène SORIANI – CHU Nice
  • Dr. Elisa DE LA CRUZ – CHU Montpellier
  • Prof. Sharam ATTARIAN – CHU Marseille

ALS expert centers (Germany):

  • Prof. Albert LUDOLPH – University of Ulm
  • Prof. Susanne PETRI – Hannover Medical School

INSERM research teams:

  • Dr. Luc DUPUIS – U1329
  • Dr. Séverine BOILLÉE – U1127
  • Prof. Hélène BLASCO – U1253
  • Prof. Patrick VOURC’H – U1253

Governance

Sponsor: 

CHU de Limoges 

Coordinator:

  • Prof. Philippe COURATIER – Medical and Scientific Principal Investigator (ALS & Motor Neuron Diseases Reference Center, CHU Limoges)
  • Dr. Luc DUPUIS – Scientific Coordinator for biological analyses
  • Dr. Daniells ERAZO – Scientific and Methodological Lead

Steering Committee: 

Philippe COURATIER, Luc DUPUIS, Daniells ERAZO, Albert LUDOLPH, Sandra JUGE

Scientific Committee: 

Philippe COURATIER, Luc DUPUIS, Pierre-Marie PREUX, Daniells ERAZO, François SALACHAS, Séverine BOILLÉE, Pierre-François PRADAT, Patrick VOURC’H, Albert LUDOLPH, Hélène BLASCO

Contact

Sponsor : BMA- CHU DE LIMOGES  2 avenue Martin Luther King 87042 Limoges Cedex

Contact: FG-CoALS@chu-limoges.fr

This data management initiative, provided by France Cohortes, is supported by the French government through the National Research Agency (ANR) under the France 2030 program, reference ANR-21-PMRB-0012.

No news has been published for this cohort, you can consult all the news in the spotlight section

Incident ALS cases will be included in the participating centers in France and Germany. Patients will be stratified according to weight loss at the time of diagnosis. A prospective follow-up will be conducted every 3 months to assess disease progression and survival, with a total follow-up period of 18 months.

A minimal dataset will be collected within the cohort, including sociodemographic characteristics, neurological, respiratory, and cognitive-behavioral assessments, as well as genetic analyses (GWAS and ALS gene panel).

A sub-cohort will be established to identify additional factors, including metabolic and metabolomic markers, neurofilaments, inflammation, and imaging.