Clinical trial NCT04001270: Core Cerebrospinal Fluid Biomarker Profile in Anti-Leucine Rich Glioma Inactivated 1 (Anti-LGI1) Encephalitis
Official title: Core Cerebrospinal Fluid Biomarker Profile in Leucine Rich Glioma Inactivated 1 (LGI1) Antibody Associated Encephalitis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Encephalitis
LGI1 Antibody Associated Encephalitis
Keywords: LGI1 encephalitis
Biomarkers
Cerebrospinal Fluid (CSF)
Neurology
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-06-28
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Absence of clinical data

Primary outcomes:
measure: Biomarker levels of leucine rich glioma inactivated 1 associated encephalitis
timeFrame: 3 months
measure: Biomarker levels of anti leucine rich glioma inactivated 1 associated encephalitis
timeFrame: 3 months
measure: Biomarker levels of anti leucine rich glioma inactivated 1 associated encephalitis
timeFrame: 3 months
Secondary outcomes:
measure: 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)
timeFrame: two weeks
measure: Comparison of biomarker profile in anti leucine rich glioma inactivated 1 associated encephalitis (LGI1-E) with versus without faciobrachial dystonic seizures.
timeFrame: two weeks
Other outcomes:
Locations:
Study officials:
affiliation: Hospices Civils de Lyon
name: Virginie DESESTRET
role: PRINCIPAL_INVESTIGATOR
References: