Clinical trial NCT06147843: French-German Cohort Study to Determine Factors Associated With Weight Loss in Amyotrophic Lateral Sclerosis
Official title: French-German Cohort Study to Determine Factors Associated With Weight Loss in Amyotrophic Lateral Sclerosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Amyotrophic Lateral Sclerosis
Keywords: Amyotrophic lateral sclerosis
Weight Loss
Genetics
Nutrition
Prognosis
Metabolomics
Inflammation
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
Collaborators: name: National Research Agency, France
name: Centre de Recherche en biomédecine de Strasbourg INSERM UMR-S1118
name: Institut du Cerveau et de la Moelle épinière
name: Institut National de la Santé et de la Recherche Médical - délégation Grand Ouest INSERM U1253
name: Klinik für Neurologie, Universitäts- und Rehabilitationskliniken Ulm (RKU)
name: Centre de Données Cliniques et de Recherche CDCR
name: UMR Inserm U1253-IBRain-Neurogénétique et Physiopathologie Neuronale
name: France Cohorte
First posted: 2023-11-28
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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.

Eligibility 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.

Primary outcomes:
measure: Survival
timeFrame: every 6 month until 18 months of follow up
Secondary outcomes:
measure: Disease progression (ALSFRS-R slope)
timeFrame: every 6 month until 18 months of follow up
Other outcomes:
Locations:
city: Lille
country: France
facility: CHU de Lille
city: Limoges
country: France
facility: Limoges University Hospital
city: Marseille
country: France
facility: Hôpital de la Timone
city: Montpellier
country: France
facility: Hôpital Gui Chauliac
city: Nice
country: France
facility: CHU de Nice
city: Paris
country: France
facility: Hôpital de la Pitié Salpêtrière
city: Tours
country: France
facility: CHU de Tours
Study officials:
affiliation: University Hospital, Limoges
name: Philippe COURATIER, Professor
role: PRINCIPAL_INVESTIGATOR
References: