EncephalitisLGI1biomNCT04001270
Core Cerebrospinal Fluid Biomarker Profile in Anti-Leucine Rich Glioma Inactivated 1 (Anti-LGI1) Encephalitis
An observational study of Encephalitis and LGI1 Antibody Associated Encephalitis, run by Hospices Civils de Lyon.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Encephalitis, LGI1 Antibody Associated Encephalitis
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2019to 15 Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- Absence of clinical data
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Core Cerebrospinal Fluid Biomarker Profile in Leucine Rich Glioma Inactivated 1 (LGI1) Antibody Associated Encephalitis
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.
- Keywords
- LGI1 encephalitis, Biomarkers, Cerebrospinal Fluid (CSF), Neurology
- Medical subject headings
- Encephalitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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)
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.
Measured: two weeks
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.
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2019
- Study start15 Jul 2019 (estimated)
- Primary completion15 Aug 2019 (estimated)
- Study completion15 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EncephalitisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Virginie DESESTRET, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04001270
- Sponsor's protocol ID
- LGI1biom
- Acronym
- LGI1biom
- Status last verified
- Jun 2019
- First submitted
- 16 May 2019
- Last updated
- 28 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Core Cerebrospinal Fluid Biomarker Profile in Leucine Rich Glioma Inactivated 1 (LGI1) Antibody Associated Encephalitis
- ClinicalTrials.gov ID
- NCT04001270
- Acronym / sponsor ID
- LGI1biom / LGI1biom
- Keywords
- LGI1 encephalitis, Biomarkers, Cerebrospinal Fluid (CSF), Neurology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 15 Jul 2019 (estimated)
- Primary completion
- 15 Aug 2019 (estimated)
- Study completion
- 15 Nov 2019 (estimated)
- First posted
- 28 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Absence of clinical data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Biomarker levels of leucine rich glioma inactivated 1 associated encephalitis
Time frame: 3 months
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.
Biomarker levels of anti leucine rich glioma inactivated 1 associated encephalitis
Time frame: 3 months
Neopterin Cerebrospinal Fluid (CSF) levels (nanomole/Liter, nmol/L) will be assessed in anti Leucine-rich Glioma inactivated-1 Encephalitis (LGI1-E) patients.
Biomarker levels of anti leucine rich glioma inactivated 1 associated encephalitis
Time frame: 3 months
Prion protein Cerebrospinal Fluid (CSF) levels (ug/L) will be assessed in LGI1-E patients
2 secondary outcomes
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)
Time frame: two weeks
Comparison of biomarker profile in anti leucine rich glioma inactivated 1 associated encephalitis (LGI1-E) with versus without faciobrachial dystonic seizures.
Time frame: two weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Virginie DESESTRET principal investigator
Hospices Civils de Lyon
Questions about this trial
What is this clinical trial studying?
An observational study of Encephalitis and LGI1 Antibody Associated Encephalitis, run by Hospices Civils de Lyon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Virginie DESESTRET (4 72 11 80 41 ext. 33, virginie.desestret@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarker levels of leucine rich glioma inactivated 1 associated encephalitis (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2019.