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NCT06147843 | RECRUITING | Amyotrophic Lateral Sclerosis


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

University Hospital, Limoges

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.

Condition or disease

Amyotrophic Lateral Sclerosis

Intervention/treatment

Blood sample

Phase

NA

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 1000 participants
Masking : NONE
Primary Purpose : OTHER
Official Title : French-German Cohort Study to Determine Factors Associated With Weight Loss in Amyotrophic Lateral Sclerosis
Actual Study Start Date : 2024-09-17
Estimated Primary Completion Date : 2027-09-30
Estimated Study Completion Date : 2029-09-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.

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

Location Details

NCT06147843


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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


NOT YET RECRUITING

France,

chu's Lille

Lille, France, 59037

RECRUITING

France,

Limoges University Hospital

Limoges, France, 87042

NOT YET RECRUITING

France,

Timone Hospital

Marseille, France, 13005

NOT YET RECRUITING

France,

Gui Chauliac Hospital

Montpellier, France, 34295

NOT YET RECRUITING

France,

chu's nice

Nice, France, 06001

NOT YET RECRUITING

France,

Pitié Salpêtrière Hospital

Paris, France, 75013

NOT YET RECRUITING

France,

Chu's tours

Tours, France, 37044

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