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

Not Applicable

Recruiting

• Conditions: Alzheimer Disease; Myasthenia
• Interventions: Procedure: Adults with Alzheimer's disease; Procedure: Adults with Myasthenia; Other: Healhty controls

• Registration Number: NCT06523296
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-17
• Study First Submitted: 2024-07-23
• Study First Submitted QC: 2024-07-23
• Study First Posted: 2024-07-26
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-02
• Primary Completion: 2026-05-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adults with Alzheimer's disease	Adults with Alzheimer's disease	-
Adults with Myasthenia	Adults with Myasthenia	-
healthy volonteer	Healhty controls	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Measurement of RACH antibodies in serum	at day 0	dosage by ELISA method of RACH antibodies
Measurement of RACH antibodies in cerebrospinal liquid	at day 0	dosage by ELISA method of RACH antibodies

Trial Locations

Locations (1)

CHU de Nice; 🇫🇷 Nice, Alpes Maritimes, France