Status:
RECRUITING
Presence of Anti-RACH Antibodies and Neurocognitive Disorder in Myasthenic or Alzheimers's Patients.
Lead Sponsor:
Centre Hospitalier Universitaire de Nice
Conditions:
Alzheimer Disease
Myasthenia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of the study is to evaluate if there is a specific association between the presence of anti Rach antibodies in the CSF and the presence of a cogntive disorder in myasthenic patients. Moreo...
Eligibility Criteria
Inclusion
- Inclusion criteria
- For patient with myasthenia :
- adult person,
- Diagnosis of anti-AChR positive autoimmune myasthenia gravis, confirmed by clinical and biological data, and categorized in class I to IV according to the Myasthenia Gravis Foundation of America (MGFA) classification,
- Mild or major neurocognitive disorder (DSM-5 criterion) having benefited from a diagnosis at the CMRR with CSF biomarker dosage and agreement to bio-collect residual CSF,
- Agreeing to sign the free and informed consent,
- Affiliate or beneficiary of a social security system.
- For patient with Alzheimer Disease :
- adult person,
- Mild or major neurocognitive disorder (DSM-5 criterion) having benefited from a diagnosis at the CMRR with CSF biomarker dosage and agreement to bio-collect residual CSF,
- Neurocognitive disorder only linked to Alzheimer's disease (IWG-2 criterion): typical or atypical clinical form with biomarkers of Alzheimer's disease in the CSF;
- Agreeing to sign the free and informed consent,
- Affiliate or beneficiary of a social security system.
- For healty control :
- absence of memory complaint,
- absence of neurocognitive disorder,
- Having agreed to carry out analyzes as part of research, on these CSF samples stored in the biobank of the Institute of Translational Neurology in Münster (Germany)
- Exclusion Criteria:
- For patient with myasthenia :
- Person who does not have sufficient command of the French language to understand, read and write, to take neuropsychological tests;
- Need to use the routine complementary CSF tube to carry out additional diagnostic explorations as part of routine care,
- Vulnerable people are defined in articles L1121-5 to -8 ( Pregnant women, parturients and breastfeeding mothers, persons deprived of their liberty by a judicial or administrative decision, persons hospitalized without consent under articles L. 3212-1 and L. 3213-1 who do not fall under the provisions of article L. 1121-8, and persons admitted to a health or social establishment for purposes other than research/Adults who are subject to a legal protection measure or who are unable to express their consent.),
- For patient with Alzheimer Disease :
- 1\) vulnerable people are defined in articles L1121-5 to -8 ( Pregnant women, parturients and breastfeeding mothers, persons deprived of their liberty by a judicial or administrative decision, persons hospitalized without consent under articles L. 3212-1 and L. 3213-1 who do not fall under the provisions of article L. 1121-8, and persons admitted to a health or social establishment for purposes other than research/Adults who are subject to a legal protection measure or who are unable to express their consent.)
Exclusion
Key Trial Info
Start Date :
April 17 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06523296
Start Date
April 17 2024
End Date
June 1 2026
Last Update
April 2 2025
Active Locations (1)
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1
CHU de Nice
Nice, Alpes Maritimes, France, 06000