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

NCT06523296 | Recruiting

• 1 other identifier: 22-AOI-08
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease; Myasthenia

Keywords

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

Outcome Measures

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.

  at day 0

Secondary Outcomes (2)

• Measurement of RACH antibodies in serum

  at day 0

• Measurement of RACH antibodies in cerebrospinal liquid

  at day 0

Study Arms (3)

Adults with Alzheimer's disease

EXPERIMENTAL

Procedure: Adults with Alzheimer's disease

Adults with Myasthenia

EXPERIMENTAL

Procedure: Adults with Myasthenia

healthy volonteer

EXPERIMENTAL

Other: Healhty controls

Interventions

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 Alzheimer's disease

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.

Adults with Myasthenia

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

healthy volonteer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice

Nice, Alpes Maritimes, 06000, France

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Amyloid beta-Protein Precursor

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amyloidogenic Proteins; Amyloid; Proteins; Amino Acids, Peptides, and Proteins; Membrane Proteins; Protein Precursors; Protease Nexins; Proteinase Inhibitory Proteins, Secretory

Study Officials

• SACCO GUILLAUME, MD

  Centre Hospitalier Universitaire de Nice

  PRINCIPAL INVESTIGATOR

Central Study Contacts

LEMAIRE JUSTINE

CONTACT

33492034778; lemaire.j@chu-nice.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: MYASTHENIA, ALZHEIMER'S DISEASES, healthy control

Study Record Dates

• First Submitted: July 23, 2024
• First Posted: July 26, 2024
• Study Start: April 17, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)