Clinical trial NCT01962311: Evaluation of Metabolomic Analysis in Early Diagnosis of ALS
Official title: Evaluation of Metabolomic Analysis in Early Diagnosis of ALS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ALS
Keywords: ALS
Spinal Cerebrospinal Fluid
Urine
SERUM
Diagnosis
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2013-10-14
Enrollment: 82
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This project is expected to answer the question of interest assays of metabolites in the CSF as a tool for early diagnosis and should show whether it is possible or not to use such markers in the blood or urine. These studies should also help shed light on the pathophysiological original early clinical disease. While ALS appears to be more a clinical syndrome that pathophysiological entity unique metabolic abnormalities identified could help identify mechanisms disrupted in which therapeutic interventions will be possible.

Detailed description: A blood test that would allow the diagnosis

1. to reduce the time between the first signs and diagnosis in ALS patients for therapeutic treatment earlier and
2. to exclude rapidly non ALS in their avoiding unnecessary investigations and anxiety of being infected with a terrible prognosis disease. It is currently accepted that neurodegenerative diseases such as ALS begin before the first clinical signs and the patient could benefit from a more efficient care if it was early.

Conduct a prospective study with 400 patients.

The secondary objectives are:

1. attempt to improve the predictive power of markers assays by adding new parameters
2. to check whether the assayed molecules in other environments more accessible (blood, urine) would provide equivalent diagnostic power of those assayed in the CSF
3. identify metabolic pathways disrupted early that could be related to the pathogenesis of neurodegeneration.

Eligibility criteria: Inclusion Criteria:

* age 30-80
* Consent signed
* affiliation to a social security organism

Exclusion Criteria:

* Patients treated with RILUZOLE
* Enrollment in an other study

Primary outcomes:
measure: Diagnostic markers studied are metabolites of cerebrospinal fluid, blood and urine measured by three complementary analytical methods
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: Pôle Neurosciences et Spécialités ,Service de Neurologie,CHU d'Angers
city: Lille
country: France
facility: Service de Neurologie et Pathologie du Mouvement Clinique de Neurologie, Pôle des Neurosciences et de l'Appareil Locomoteur INSERM U 837
city: Paris
country: France
facility: Centre de Recherche de l'Institut du Cerveau et de la moëlle UPMC Paris 6,Département des Maladies du Système Nerveux
city: Poitiers
country: France
facility: Service de neurologie, CHU La Milétrie, POITIERS, Faculté de Médecine
city: Strasbourg
country: France
facility: University Hospital
city: Tours
country: France
facility: CHRU -TOURS-Service de Neurologie
Study officials:
affiliation: University Hospital TOURS and INSERM U930
name: Christian ANDRES, MD-PHD
role: STUDY_DIRECTOR
References: