Ignite Creation Date:
2024-05-06 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06147843
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-28
First Post:
2023-07-12
Brief Title:
French-German Cohort Study to Determine Factors Associated With Weight Loss in Amyotrophic Lateral Sclerosis
Sponsor:
University Hospital Limoges
Organization:
University Hospital Limoges
Study Overview
Official Title:
French-German Cohort Study to Determine Factors Associated With Weight Loss in Amyotrophic Lateral Sclerosis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FG-CoALS
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None