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

Amyotrophic Lateral Sclerosis Clinical Trial

— FG-CoALS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06147843
• Other study ID #: 87RI21_0053
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 20, 2024
• Est. completion date: March 31, 2028

Study information

• Verified date: June 2023
• Source: University Hospital, Limoges
• Contact: Philippe COURATIER, Pr
• Phone: 05 55 05 15 69
• Email: philippe.couratier[@]chu-limoges.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: March 31, 2028
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis
• Weight Loss

Intervention

Other:
• Blood sample
Blood sample will be taken to identify Genomic, metabolomic, metabolic, neurofilaments, and inflammation markers associated to weight loss

Locations

Country	Name	City	State
France	Limoges University Hospital	Limoges

Sponsors (9)

Lead Sponsor

Collaborator

University Hospital, Limoges

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

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival	Survival evaluated in month since diagnosis	every 6 month until 18 months of follow up
Secondary	Disease progression (ALSFRS-R slope)	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