NCT06523296 · RECRUITING
Presence of Anti-RACH Antibodies and Neurocognitive Disorder in Myasthenic or Alzheimers's Patients.
This study looks for a possible connection between a specific antibody — called anti-AChR — and cognitive decline in two groups: people with Alzheimer's disease and people with myasthenia gravis (a neuromuscular condition). Researchers will test stored spinal fluid and one new blood draw. It is an observational study, not a drug trial — no treatment is being tested, and nothing is being given to participants beyond a blood draw.
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.)
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-04-02