Investigating the link between anti-RACH antibodies and cognitive disorders in myasthenia and Alzheimer'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.

This study is trying to see if certain antibodies in the spinal fluid are connected to memory problems in people with myasthenia gravis and Alzheimer's disease.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Centre Hospitalier Universitaire de Nice (Academic / other)
• Locations: 1 site (Nice, Alpes Maritimes)
• Trial ID: NCT06523296 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the association between the presence of anti-RACH antibodies in cerebrospinal fluid (CSF) and cognitive disorders in patients with myasthenia gravis. It will also explore potential links between these antibodies and Alzheimer's disease. Participants will include adults diagnosed with either condition who have undergone diagnostic procedures, including lumbar puncture. An additional blood draw will be performed, and historical CSF samples will be analyzed alongside serum collected during the study.

Who should consider this trial

Good fit: Ideal candidates include adults diagnosed with anti-AChR positive autoimmune myasthenia gravis or Alzheimer's disease with confirmed neurocognitive disorders.

Not a fit: Patients without a diagnosis of myasthenia gravis or Alzheimer's disease, or those without cognitive disorders, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of cognitive disorders in myasthenia and Alzheimer's patients, potentially leading to improved diagnostic and therapeutic strategies.

How similar studies have performed: While the specific link between anti-RACH antibodies and cognitive disorders is novel, similar studies exploring antibody associations in neurodegenerative diseases have shown promise.

Eligibility criteria

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.)

Where this trial is running

Nice, Alpes Maritimes

• CHU de Nice — Nice, Alpes Maritimes, France (Recruiting)

Study contacts

• Principal investigator: Sacco Guillaume, Md — Centre Hospitalier Universitaire de Nice
• Study coordinator: Lemaire Justine

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