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Hunting for hidden antibodies in brain inflammation

NCT ID NCT07477015

Knowledge-focused Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study aims to better understand autoimmune encephalitis, a condition where the immune system attacks the brain. Researchers will analyze blood and spinal fluid from 20 patients to find new antibodies that may explain the disease in people who currently test negative. The goal is to improve diagnosis and uncover the underlying causes of this rare disorder.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could help identify new antibodies that explain the disease in currently undiagnosed patients, potentially leading to better diagnostic tests.
What could go wrong
This is a small, early-stage observational study with only 20 participants, so findings may not apply broadly. Discovering new antibodies is uncertain and may not directly lead to treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * Patients ≤ 18 years of age * Deceased patients

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Conditions

The condition(s) this trial relates to.

anti-NMDA receptor encephalitis autoimmune disorder of the nervous system autoimmune encephalitis limbic encephalitis with LGI1 antibodies Susac syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Autoimmune encephalitis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Fondazione Policlinico Universitario A. Gemelli IRCCS

    RECRUITING

    Rome, RM, 00168, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.