Autoimmune EncephalitisAE_AbsNCT07477015
Study of Pathogenic Mechanisms and Identification of Novel Autoantibodies in Autoimmune Encephalitis
An observational study of Autoimmune Encephalitis, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Autoimmune encephalitis is a debilitating neurological disorder that usually appears as a rapidly progressive form of brain dysfunction, typically developing in less than six weeks, caused by inflammation in the brain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autoimmune Encephalitis
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 31 Jul 2025to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: For the autoimmune encephalitis group: Patients diagnosed with encephalitis associated with antibodies against NMDAR, GABABR, AMPAR, LGI-1, DNER, seronegative autoimmune encephalitis, and Susac syndrome belonging to the IRCCS Fondazione Policlinico A. Gemelli on an outpatient basis, who meet the inclusion and exclusion criteria of the study, will be enrolled consecutively. For the control group: patients with other neurological disorders, in whom the presence of antibodies against neuronal antigens has been excluded, belonging to the IRCCS Fondazione Policlinico A. Gemelli on an outpatient basis, who meet the inclusion and exclusion criteria of the study, will be enrolled consecutively.
Who may be able to join
- Patients > 18 years of age
- Patients able to provide informed consent
- For the patient group: patients diagnosed with autoimmune encephalitis associated with anti-NMDAR, GABABR, AMPAR, LGI-1, DNER antibodies, seronegative autoimmune encephalitis, or Susac syndrome, without other concomitant autoimmune diseases
- For the control group: patients without a diagnosis of autoimmune encephalitis associated with anti-NMDAR, GABABR, AMPAR, LGI-1, DNER antibodies, seronegative autoimmune encephalitis, or Susac syndrome
- For the control group: patients with other neurological disorders in whom the presence of antibodies against neuronal antigens has been excluded
Who cannot join
- Patients ≤ 18 years of age
- Deceased patients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, RM, 00168
Raffaele Iorio, 0630155930, raffaele.iorio@policlinicogemelli.it
About this study
Official title: Study of Pathogenic Mechanisms and Identification of Novel Autoantibodies in Autoimmune Encephalitis Through the Integration of Conventional Methodologies and Advanced Single-cell Technologies
Autoimmune encephalitis is a debilitating neurological disorder that usually appears as a rapidly progressive form of brain dysfunction, typically developing in less than six weeks, caused by inflammation in the brain. These conditions show a wide range of clinical and immunological presentations and are generally divided into two main types.
The first type includes what are called paraneoplastic syndromes. In these cases, the immune system produces antibodies in response to a tumor that mistakenly target parts of the nervous system. The antibodies are not directly harmful themselves, but they are a sign that the immune system has launched a T-cell-driven attack on brain tissue because it recognizes a protein that's found both in the tumor and in the nervous system. These forms usually follow a single, non-repeating course and tend to respond poorly to treatment, which mostly focuses on removing or treating the underlying tumor and using immunotherapy to reduce the immune response.
Read more
The second type includes what we more properly call autoimmune encephalitis, where the immune system produces antibodies that directly attack proteins on the surface of neurons or on synaptic receptors in the brain. Unlike in paraneoplastic syndromes, these antibodies are directly responsible for the disease, and they don't usually indicate the presence of a tumor. Most people with this type of autoimmune encephalitis-around 70% to 80%-respond well to treatment with immunotherapy and can make a good or even full recovery. However, in about 20% of cases, the disease can come back or lead to long hospital stays, with a slower or only partial recovery.
There is also a third group of autoimmune encephalitides where the antibodies target synaptic proteins. These may or may not be linked to cancer, and the proteins they target are usually found inside the cells rather than on their surface.
A fourth group includes what are called seronegative autoimmune encephalitides. These are cases that meet the clinical criteria for autoimmune encephalitis, but no specific antibodies have been identified so far. Among the autoimmune neurological disorders without known antibodies is Susac syndrome, a rare condition that affects the brain, the retina, and the inner ear. It's especially interesting because its features suggest the involvement of antibodies, even though no disease-causing antibodies have yet been found.
The diagnosis of autoimmune encephalitis is based on clinical signs and symptoms, the detection of specific antibodies in blood or spinal fluid, and, in paraneoplastic cases, identifying the underlying tumor. To detect autoantibodies, doctors use various lab techniques, including immunoblotting and different types of immunofluorescence tests-some based on cultured cells, others on brain tissue from rodents.
Despite important progress in recent years, many cases of autoimmune encephalitis remain undiagnosed. One reason is that the disease can begin with vague or incomplete symptoms, making it difficult to recognize. Another issue is that current testing methods might not be sensitive enough to detect all possible antibodies. This means that the group of patients diagnosed with seronegative autoimmune encephalitis might actually include people who have antibodies we just haven't discovered yet.
In many cases, especially in the seronegative forms, the exact cause of the disease is still not fully understood.
The main goal of this study is to better understand how autoimmune encephalitis develops, especially in cases involving antibodies that target proteins on the surface of brain cells-such as NMDAR, GABABR, AMPAR, LGI1, and DNER-as well as in seronegative autoimmune encephalitis and in Susac syndrome. A second goal is to try to discover new autoantibodies that could explain the disease in patients who currently test negative.
Read the detailed description
Prospective and retrospective observational study
- Conditions
- Autoimmune Encephalitis
- Medical subject headings
- Autoimmune Diseases of the Nervous System
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 |
|---|---|---|
| autoimmune encephalitis group | Patients diagnosed with encephalitis associated with antibodies against NMDAR, GABABR, AMPAR, LGI-1, DNER, seronegative autoimmune encephalitis, and Susac syndrome. | |
| Control Group | A control group consisting of patients with other neurological disorders, in whom the presence of antibodies against neuronal antigens has been excluded, will also be enrolled. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Generate human recombinant monoclonal antibodies (mAbs) specific to the target antigen from patients' B cells
To generate monoclonal antibodies (mAbs) from autoreactive B cells of patients, we will use LIBRA-seq (Linking B-cell Receptor to Antigen specificity through sequencing), a recently developed technique.
Measured: 12 months
Secondary outcomes (1)
Isolate polyclonal IgG from the serum of patients with autoimmune encephalitis associated with known antibodies, seronegative autoimmune encephalitis, and Susac syndrome
IgGs will be purified (at a concentration of 2 mg/ml) from the serum of various patients using protein A/G Sepharose chromatography with the Melon™ Gel IgG Purification Kit. Protein concentration will be measured using the BCA Protein Assay Kit. All samples will be dialyzed against phosphate-buffered saline (PBS), and the solutions will be used at pH 7.4.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start31 Jul 2025
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune EncephalitisStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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
- Other
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raffaele Iorio, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07477015
- Sponsor's protocol ID
- 6379
- Acronym
- AE_Abs
- Status last verified
- Jul 2025
- First submitted
- 14 Apr 2025
- Last updated
- 17 Mar 2026
- 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 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Pathogenic Mechanisms and Identification of Novel Autoantibodies in Autoimmune Encephalitis Through the Integration of Conventional Methodologies and Advanced Single-cell Technologies
- ClinicalTrials.gov ID
- NCT07477015
- Acronym / sponsor ID
- AE_Abs / 6379
- Conditions
- Autoimmune Encephalitis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 31 Jul 2025 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 17 Mar 2026 (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.
Autoimmune encephalitis is a debilitating neurological disorder that usually appears as a rapidly progressive form of brain dysfunction, typically developing in less than six weeks, caused by inflammation in the brain. These conditions show a wide range of clinical and immunological presentations and are generally divided into two main types.
The first type includes what are called paraneoplastic syndromes. In these cases, the immune system produces antibodies in response to a tumor that mistakenly target parts of the nervous system. The antibodies are not directly harmful themselves, but they are a sign that the immune system has launched a T-cell-driven attack on brain tissue because it recognizes a protein that's found both in the tumor and in the nervous system. These forms usually follow a single, non-repeating course and tend to respond poorly to treatment, which mostly focuses on removing or treating the underlying tumor and using immunotherapy to reduce the immune response.
The second type includes what we more properly call autoimmune encephalitis, where the immune system produces antibodies that directly attack proteins on the surface of neurons or on synaptic receptors in the brain. Unlike in paraneoplastic syndromes, these antibodies are directly responsible for the disease, and they don't usually indicate the presence of a tumor. Most people with this type of autoimmune encephalitis-around 70% to 80%-respond well to treatment with immunotherapy and can make a good or even full recovery. However, in about 20% of cases, the disease can come back or lead to long hospital stays, with a slower or only partial recovery.
There is also a third group of autoimmune encephalitides where the antibodies target synaptic proteins. These may or may not be linked to cancer, and the proteins they target are usually found inside the cells rather than on their surface.
A fourth group includes what are called seronegative autoimmune encephalitides. These are cases that meet the clinical criteria for autoimmune encephalitis, but no specific antibodies have been identified so far. Among the autoimmune neurological disorders without known antibodies is Susac syndrome, a rare condition that affects the brain, the retina, and the inner ear. It's especially interesting because its features suggest the involvement of antibodies, even though no disease-causing antibodies have yet been found.
The diagnosis of autoimmune encephalitis is based on clinical signs and symptoms, the detection of specific antibodies in blood or spinal fluid, and, in paraneoplastic cases, identifying the underlying tumor. To detect autoantibodies, doctors use various lab techniques, including immunoblotting and different types of immunofluorescence tests-some based on cultured cells, others on brain tissue from rodents.
Despite important progress in recent years, many cases of autoimmune encephalitis remain undiagnosed. One reason is that the disease can begin with vague or incomplete symptoms, making it difficult to recognize. Another issue is that current testing methods might not be sensitive enough to detect all possible antibodies. This means that the group of patients diagnosed with seronegative autoimmune encephalitis might actually include people who have antibodies we just haven't discovered yet.
In many cases, especially in the seronegative forms, the exact cause of the disease is still not fully understood.
The main goal of this study is to better understand how autoimmune encephalitis develops, especially in cases involving antibodies that target proteins on the surface of brain cells-such as NMDAR, GABABR, AMPAR, LGI1, and DNER-as well as in seronegative autoimmune encephalitis and in Susac syndrome. A second goal is to try to discover new autoantibodies that could explain the disease in patients who currently test negative.
Detailed description
Prospective and retrospective observational study
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| autoimmune encephalitis group | – | –Patients diagnosed with encephalitis associated with antibodies against NMDAR, GABABR, AMPAR, LGI-1, DNER, seronegative autoimmune encephalitis, and Susac syndrome. |
| Control Group | – | –A control group consisting of patients with other neurological disorders, in whom the presence of antibodies against neuronal antigens has been excluded, will also be enrolled. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- For the autoimmune encephalitis group: Patients diagnosed with encephalitis associated with antibodies against NMDAR, GABABR, AMPAR, LGI-1, DNER, seronegative autoimmune encephalitis, and Susac syndrome belonging to the IRCCS Fondazione Policlinico A. Gemelli on an outpatient basis, who meet the inclusion and exclusion criteria of the study, will be enrolled consecutively. For the control group: patients with other neurological disorders, in whom the presence of antibodies against neuronal antigens has been excluded, belonging to the IRCCS Fondazione Policlinico A. Gemelli on an outpatient basis, who meet the inclusion and exclusion criteria of the study, will be enrolled consecutively.
Key inclusion criteria (5 listed)
- Patients > 18 years of age
- Patients able to provide informed consent
- For the patient group: patients diagnosed with autoimmune encephalitis associated with anti-NMDAR, GABABR, AMPAR, LGI-1, DNER antibodies, seronegative autoimmune encephalitis, or Susac syndrome, without other concomitant autoimmune diseases
- For the control group: patients without a diagnosis of autoimmune encephalitis associated with anti-NMDAR, GABABR, AMPAR, LGI-1, DNER antibodies, seronegative autoimmune encephalitis, or Susac syndrome
- For the control group: patients with other neurological disorders in whom the presence of antibodies against neuronal antigens has been excluded
Key exclusion criteria (2 listed)
- Patients ≤ 18 years of age
- Deceased patients
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
Generate human recombinant monoclonal antibodies (mAbs) specific to the target antigen from patients' B cells
Time frame: 12 months
To generate monoclonal antibodies (mAbs) from autoreactive B cells of patients, we will use LIBRA-seq (Linking B-cell Receptor to Antigen specificity through sequencing), a recently developed technique.
1 secondary outcome
Isolate polyclonal IgG from the serum of patients with autoimmune encephalitis associated with known antibodies, seronegative autoimmune encephalitis, and Susac syndrome
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
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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.
Raffaele Iorio principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autoimmune Encephalitis, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 5 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Raffaele Iorio (+390630155930, raffaele.iorio@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Generate human recombinant monoclonal antibodies (mAbs) specific to the target antigen from patients' B cells (time frame: 12 months). 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 17 Mar 2026.