Presence of Anti-RACH Antibodies and Neurocognitive Disorder in Myasthenic or Alzheimers's Patients.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de Nice
About this trial
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. Moreover the investigator wants to study if there is a link between the presence of Anti RACH antibodies in myasthenia and Alzheimers's disease.
For that, the investigator will recruit myasthenic patient with cognitive disorder that has undergo a diagnostic process including lombar punction for memory trouble in Nice memory center as well as Alzheimer's patient having go through the same process.
The study will consist in one additionnal blood draw. Anti RACH antibodies will be analyzed in historical CSF stored in biocollection and serum collected for the study.
LCS of healthy control will also be analyzed.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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,
Disqualifiers
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.),
Trial design
Design model
Parallel
Treatments tested in this trial
Adults with Alzheimer's disease
Procedure/SurgeryEach patient will undergo a blood draw for the analysis of RACH antibodies in serum. Also an aliquot of frozen spinal fluid of patient kept in biobank ( spinal fluid taken during a puncture as part of routine care) will be used for the analysis of RACH antibodies.
Adults with Myasthenia
Procedure/SurgeryEach patient will undergo a blood draw for the analysis of RACH antibodies in serum. Also an aliquot of frozen spinal fluid of patient kept in biobank ( spinal fluid taken during a puncture as part of routine care) will be used for the analysis of RACH antibodies.
Healhty controls
Other interventionFrozen spinal fluid of 10 healthy controlled stored in a biobank in Munster, Germanywill be compared to the ones of Adults with Myasthenia and Adults with Alzheimer's disease
Treatment groups
30 Participants
are divided into 3 treatment groupsGroup A: Adults with Alzheimer's diseaseExperimental treatment 1 intervention
Group B: Adults with MyastheniaExperimental treatment 1 intervention
Group C: healthy volonteerExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The ratio of the number of myasthenic patients with NS-NCD that may be related to myasthenia-related central nervous system damage to the total number of myasthenic patients with CND from all causes combined.
Time frame
at day 0Secondary outcomes
1
Measurement of RACH antibodies in serum
dosage by ELISA method of RACH antibodies
Time frame
at day 02
Measurement of RACH antibodies in cerebrospinal liquid
dosage by ELISA method of RACH antibodies
Time frame
at day 0Sponsors and contacts
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Source ClinicalTrials.gov