Presence of Anti-RACH Antibodies and Neurocognitive Disorder in Myasthenic or Alzheimers's Patients.

Launched by CENTRE HOSPITALIER UNIVERSITAIRE DE NICE · Jul 23, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the connection between certain antibodies, known as anti-RACH antibodies, and cognitive disorders in patients with myasthenia gravis and Alzheimer’s disease. Researchers want to find out if these antibodies, which can be detected in the cerebrospinal fluid (the fluid surrounding the brain and spinal cord), are linked to memory and thinking problems in people with these conditions. To do this, they will recruit adults diagnosed with myasthenia gravis who also have cognitive issues, as well as patients diagnosed with Alzheimer’s disease.

To participate, individuals must be adults with specific diagnoses—myasthenia gravis confirmed by tests and Alzheimer's patients with clear signs of the disease. Participants will undergo an additional blood draw and their stored cerebrospinal fluid samples will be analyzed for the presence of these antibodies. If you're considering joining this study, it’s important to know that there are certain criteria to meet and that the research aims to improve understanding of how these conditions might be related.

Gender

ALL

Eligibility criteria

• • Inclusion criteria
• For patient with myasthenia :
• • 1. adult person,
• • 2. 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,
• • 3. 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,
• • 4. Agreeing to sign the free and informed consent,
• • 5. Affiliate or beneficiary of a social security system.
• For patient with Alzheimer Disease :
• • 1. adult person,
• • 2. 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,
• • 3. 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;
• • 4. Agreeing to sign the free and informed consent,
• • 5. Affiliate or beneficiary of a social security system.
• For healty control :
• • 1. absence of memory complaint,
• • 2. absence of neurocognitive disorder,
• • 3. 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 :
• • 1. Person who does not have sufficient command of the French language to understand, read and write, to take neuropsychological tests;
• • 2. Need to use the routine complementary CSF tube to carry out additional diagnostic explorations as part of routine care,
• • 3. 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.)