Status:
RECRUITING
Stratification of Presymptomatic Amyotrophic Lateral Sclerosis: the Development of Novel Imaging Biomarkers
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Amyotrophic lateral sclerosis (ALS) is a relentlessly progressive neurodegenerative disorder with no effective disease-modifying therapies at present. The disease is sporadic in 90 % of the ALS patien...
Detailed Description
The main objective is to study the disease trajectory from the presymptomatic to the symptomatic phase of ALS. We will study a population of asymptomatic subjects carrying an autosomal dominant GGGGCC...
Eligibility Criteria
Inclusion
- Inclusion criteria shared by all the different cohorts and controls :
- Age more than 18 years.
- Signature of a consent form for clinical, paraclinical and genetic assessment
- Fluent in French
- Affiliated to the French Security Healthcare System ("Sécurité Sociale")
- Absence of neurological comorbidity (stroke, tumor etc)
- The inclusion criteria for asymptomatic relatives :
- Being a first-degree to a person carrying a C9orf72 mutation.
- Absence of proven clinical signs of FTD, ALS, language, praxic, memory disorders, Parkinsonian syndrome.
- Inclusion criteria for symptomatic ALS patients :
- Patients fulfilling the El Escorial criteria for probable or definite ALS
- Presence of a C9orf72 mutation
- Exclusion criteria for participants from all cohorts :
- Contraindication to MRI and TMS
- Impossibility to stay in decubitus during 1 hour,
- For women, childbearing or breastfeeding
- For women of childbearing potential: positive HCG test or positive urine pregnancy test
Exclusion
Key Trial Info
Start Date :
July 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 21 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05358431
Start Date
July 21 2022
End Date
February 21 2026
Last Update
February 20 2024
Active Locations (1)
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1
ICM, GH Pitié-Salpêtrière
Paris, France, 75013