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

NCT06147843 | Recruiting

• 1 other identifier: 87RI21_0053
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Amyotrophic Lateral Sclerosis

Keywords

Amyotrophic lateral sclerosis; Weight Loss; Genetics; Nutrition; Prognosis; Metabolomics; Inflammation

Outcome Measures

Primary Outcomes (1)

• Survival

  Survival evaluated in month since diagnosis

  every 6 month until 18 months of follow up

Secondary Outcomes (1)

• Disease progression (ALSFRS-R slope)

  every 6 month until 18 months of follow up

Study Arms (1)

ALL participants

OTHER

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

Interventions

Blood sample OTHER

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

ALL participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (7)

CHU de Lille

Lille, 59037, France

NOT YET RECRUITING

Limoges University Hospital

Limoges, 87042, France

RECRUITING

Hôpital de la Timone

Marseille, 13005, France

NOT YET RECRUITING

Hôpital Gui Chauliac

Montpellier, 34295, France

NOT YET RECRUITING

CHU de Nice

Nice, 06001, France

NOT YET RECRUITING

Hôpital de la Pitié Salpêtrière

Paris, 75013, France

NOT YET RECRUITING

CHU de Tours

Tours, 37044, France

NOT YET RECRUITING

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis; Weight Loss; Inflammation

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Philippe COURATIER, Professor

  University Hospital, Limoges

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe COURATIER, Pr

CONTACT

05 55 05 15 69; philippe.couratier@chu-limoges.fr

Andrea ERAZO ALEMAN, Dr

CONTACT

DaniellsAndrea.ERAZOALEMAN@chu-limoges.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2023
• First Posted: November 28, 2023
• Study Start: September 17, 2024
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2029
• Last Updated: November 25, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share

Locations

FR (7)