Core Cerebrospinal Fluid Biomarker Profile in Anti-Leucine Rich Glioma Inactivated 1 (Anti-LGI1) Encephalitis

NCT04001270 | Unknown

• 1 other identifier: LGI1biom
• Study Type: observational
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

Limbic encephalitis associated with anti leucine-rich glioma inactivated-1 LGI1 antibody (anti-LGI1) usually presents with seizures and progressive disturbance of memory and behavior. But anti-LGI1 associated encephalitis (LGI1-E) could present with a variety of features including an elective cognitive form of the disease, which mimicks a neurodegenerative condition such as Creutzfeld Jakob disease or rapidly progressive Alzheimer disease. In these patients, the appropriate diagnosis could be challenging. The primary aim of this study is to describe cerebrospinal fluid biomarkers in a cohort of LGI1-E patients as results of these markers are currently not described in LGI1-E. Moreover, patients with LGI1-E often present seizures. At this point, the impact on cerebrospinal fluid biomarkers has not been described in this condition. The secondary aims of this study are to compare cerebrospinal fluid (CSF) biomarkers in LGI1-E patients to these in other neurodegenerative conditions ( e.g. creutzfeld Jakob disease, Alzheimer disease), which are considered as a possible differential diagnosis in these patients. The last aim of this study is to look for correlations between cerebrospinal fluid biomarkers in LGI1-E and clinical data in these patients, especially seizure.

Conditions

Encephalitis; LGI1 Antibody Associated Encephalitis

Keywords

LGI1 encephalitis; Biomarkers; Cerebrospinal Fluid (CSF); Neurology

Outcome Measures

Primary Outcomes (3)

• Biomarker levels of leucine rich glioma inactivated 1 associated encephalitis

  Core CSF biomarkers (T-tau, P-tau, Amyloid β Protein Fragment 1-42 (AB1-42), AB1-40, Neurofilament light chain, in ng/L) will be assessed in LGI1-E patients and will be compared to the profile of patients presenting with common and rapid Alzheimer's disease and with Creutzfeldt Jacob disease (CJD). For each biomarker, statistical comparisions will be made by Kruskal Wallis test then if needed with Wilcoxon Mann Whitney test.

  3 months

• Biomarker levels of anti leucine rich glioma inactivated 1 associated encephalitis

  Neopterin Cerebrospinal Fluid (CSF) levels (nanomole/Liter, nmol/L) will be assessed in anti Leucine-rich Glioma inactivated-1 Encephalitis (LGI1-E) patients.

  3 months

• Biomarker levels of anti leucine rich glioma inactivated 1 associated encephalitis

  Prion protein Cerebrospinal Fluid (CSF) levels (ug/L) will be assessed in LGI1-E patients

  3 months

Secondary Outcomes (2)

• Comparison of biomarker profile (T-tau, P-tau, Amyloid β Protein Fragment 1-42 (AB1-42), AB1-40, Neurofilament light chain, in nanograms/Liter (ng/L)

  two weeks

• Comparison of biomarker profile in anti leucine rich glioma inactivated 1 associated encephalitis (LGI1-E) with versus without faciobrachial dystonic seizures.

  two weeks

Study Arms (1)

Patients anti leucine rich glioma inactivated-1 encephalitis

Biomarkers from patients with anti-leucine rich glioma inactivated 1 encephalitis (anti LGI1-E) will be studied. This is a non-interventional study involving biological samples (CSF biomarkers) already stored in biobank repositories. All stored samples were collected as part of the diagnostic process of patients with suspected autoimmune encephalitis, meaning that the standard diagnostic and therapeutic approaches will not be altered in the selected study population.

Eligibility Criteria

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

Study Population

Patients with leucine rich glioma inactivated 1 (LGI1) antibody associated encephalitis whose sample was sent for analysis at Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites auto-immunes, Lyon, for LGI1 antibody study and then stored at the biobank Neurobiotec

You may qualify if:

• Presence of well characterized leucine rich glioma inactivated 1 (LGI1) antibody in serum or cerebrospinal fluid (CSF);
• LGI1 antibody associated encephalitis diagnosis according to the international guidelines;
• At least one core CSF biomarkers sample (T-tau, P-tau, AB-1-42) available after disease onset;
• Age at least 18 years old.

You may not qualify if:

• Absence of clinical data

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

MeSH Terms

Conditions

Encephalitis

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases

Study Officials

• Virginie DESESTRET

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Virginie DESESTRET

CONTACT

4 72 11 80 41; virginie.desestret@chu-lyon.fr

Géraldine PICARD

CONTACT

4 72 35 58 42; geraldine.picard@chu-lyon.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2019
• First Posted: June 28, 2019
• Study Start: July 15, 2019
• Primary Completion: August 15, 2019
• Study Completion: November 15, 2019
• Last Updated: June 28, 2019

Record last verified: 2019-06