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

Study of the Relationship Between the Presence of Anti-AChR Antibodies in the Cerebrospinal Fluid and the Presence of Neurocognitive Disorder in Myasthenic and Alzheimers's Patients.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06523296
Acronym
ARN-MA
Enrollment
30
Registered
2024-07-26
Start date
2026-08-18
Completion date
2028-09-18
Last updated
2026-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease, Myasthenia

Keywords

Anti-RACH antibodies, Myasthenia, Alzheimer's Disease, neurocognitve disorder

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. 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.

Interventions

PROCEDUREAdults with Alzheimer's disease

Each 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.

PROCEDUREAdults with Myasthenia

Each 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.

OTHERHealhty controls

Frozen 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

Sponsors

Centre Hospitalier Universitaire de Nice
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

MYASTHENIA, ALZHEIMER'S DISEASES, healthy control

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.)

Design outcomes

Primary

MeasureTime frame
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.at day 0

Secondary

MeasureTime frameDescription
Measurement of RACH antibodies in serumat day 0dosage by ELISA method of RACH antibodies
Measurement of RACH antibodies in cerebrospinal liquidat day 0dosage by ELISA method of RACH antibodies

Countries

France

Contacts

CONTACTLEMAIRE JUSTINE
lemaire.j@chu-nice.fr33492034778
PRINCIPAL_INVESTIGATORSACCO GUILLAUME, MD

Centre Hospitalier Universitaire de Nice

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 20, 2026