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NCT Number: NCT06523296

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nice

Nice, Alpes Maritimes, 06000, France

Location status: Recruiting

Location contact

Guillaume SACCO, MD

PRINCIPAL_INVESTIGATOR

Justine LEMAIRE

CONTACT

[email protected]

33492034778

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 :

  • 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.)

Treatment and study plan

Adults with Alzheimer's disease

Procedure

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.

Adults with Myasthenia

Procedure

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.

Healhty controls

Other

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

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 0

Secondary outcomes

  1. Measurement of RACH antibodies in serum

    Time frame: at day 0

    dosage by ELISA method of RACH antibodies

  2. Measurement of RACH antibodies in cerebrospinal liquid

    Time frame: at day 0

    dosage by ELISA method of RACH antibodies

Study contacts

Contact information is provided by the study sponsor or research team.

LEMAIRE JUSTINE

CONTACT

[email protected]

33492034778

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

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.

Acronym: ARN-MA

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 26, 2024
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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