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Status unknownNCT04001270LGI1biomUpdated Jun 28, 2019

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

An observational study in Encephalitis and LGI1 Antibody Associated Encephalitis, sponsored by Hospices Civils de Lyon. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-06-28.

Sponsored by Hospices Civils de Lyon · Observational

The sponsor has not verified this record recently (last verified Jun 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
24
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Encephalitis
  • LGI1 Antibody Associated Encephalitis

Keywords

  • LGI1 encephalitis
  • Biomarkers
  • Cerebrospinal Fluid (CSF)
  • Neurology
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In context

Encephalitis

283 studies on the registry are indexed under Encephalitis; 55 are open to participants now.

This study's planned enrollment of 24 is below the median of 200 across 92 observational studies indexed under Encephalitis.

Browse Encephalitis studies →

Lead sponsor

Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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

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

Exclusion Criteria:

  • Absence of clinical data
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Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
24 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 months

  2. 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.

    Time frame: 3 months

  3. 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

    Time frame: 3 months

Secondary outcomes

  1. 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)

    Statistical comparisons of CSF biomarker levels of patients presenting with anti leucine rich glioma inactivated 1 associated encephalitis with or without epileptic seizures. Mean comparisons will be made for each biomarker, with the Wilcoxon Mann Whitney test.

    Time frame: two weeks

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

    Statistical comparisons of CSF biomarker levels of patients presenting with anti leucine rich glioma inactivated 1 associated encephalitis (LGI1-E) with or without faciobrachial dystonic seizures. Mean comparisons will be made for each biomarker, with the Wilcoxon Mann Whitney test.

    Time frame: two weeks

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 28, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04001270
Lead sponsor
Hospices Civils de Lyon
Responsible party
Sponsor
First posted
Jun 28, 2019
Start date
Jul 15, 2019 (estimated)
Primary completion
Aug 15, 2019 (estimated)
Completion
Nov 15, 2019 (estimated)
Last update
Jun 28, 2019

Study contacts

Virginie DESESTRET
Contact
virginie.desestret@chu-lyon.fr
4 72 11 80 41 ext. 33
Géraldine PICARD
Contact
geraldine.picard@chu-lyon.fr
4 72 35 58 42 ext. 33
Virginie DESESTRET
principal investigator · Hospices Civils de Lyon

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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