Identifying factors related to weight loss in ALS patients
French-German Cohort Study to Determine Factors Associated With Weight Loss in Amyotrophic Lateral Sclerosis
This study is trying to find out what causes weight loss in people with ALS by looking at their blood samples and health information to help improve their care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Limoges Academic / other |
| Locations | 7 sites (Lille and 6 other locations) |
| Trial ID | NCT06147843 on ClinicalTrials.gov |
What this trial studies
This study aims to establish a large Franco-German cohort to investigate the biological markers associated with weight loss in patients diagnosed with Amyotrophic Lateral Sclerosis (ALS). Participants will receive standard care for ALS while providing blood samples and completing questionnaires to gather data on clinical features, genetics, and metabolic status. The goal is to understand the mechanisms behind weight loss in ALS, which is critical for improving patient survival and quality of life. By identifying these markers, the study seeks to propose effective therapeutic strategies against weight loss in ALS patients.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who have recently been diagnosed with ALS and can provide informed consent.
Not a fit: Patients who are unable to understand the study protocol or who refuse Riluzole therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved therapeutic strategies that enhance survival and quality of life for ALS patients experiencing weight loss.
How similar studies have performed: While studies have highlighted the importance of weight loss in ALS, this approach to identifying biological markers is innovative and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Lille and 6 other locations
- CHU de Lille — Lille, France (Not_yet_recruiting)
- Limoges University Hospital — Limoges, France (Recruiting)
- Hôpital de la Timone — Marseille, France (Not_yet_recruiting)
- Hôpital Gui Chauliac — Montpellier, France (Not_yet_recruiting)
- CHU de Nice — Nice, France (Not_yet_recruiting)
- Hôpital de la Pitié Salpêtrière — Paris, France (Not_yet_recruiting)
- CHU de Tours — Tours, France (Not_yet_recruiting)
Study contacts
- Principal investigator: Philippe COURATIER, Professor — University Hospital, Limoges
- Study coordinator: Philippe COURATIER, Pr
- Email: philippe.couratier@chu-limoges.fr
- Phone: 05 55 05 15 69
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.