Identifying new autoantibodies and causes of autoimmune encephalitis
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
Run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT07477015 · Data updated 2026-11-12
This project looks for new autoantibodies and other disease features in adults with autoimmune encephalitis to help improve diagnosis and care.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Rome, RM) |
| Status | Recruiting |
| Started | July 31, 2025 |
| Main results expected | July 31, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | March 17, 2026 |
| Trial ID | NCT07477015 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults over 18 who can give informed consent with a confirmed diagnosis of autoimmune encephalitis (including anti-NMDAR, GABABR, AMPAR, LGI1, DNER antibody-positive cases, seronegative encephalitis, or Susac syndrome) are eligible, with a control group of adults who have other neurological disorders proven negative for neuronal antibodies.
✕Probably not a fit
Children under 18, deceased patients, and people with other concurrent autoimmune diseases are not eligible and therefore will not benefit from participation, and the observational design does not provide investigational therapies.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective and retrospective observational project that collects clinical data and biological samples from adults with antibody-associated or seronegative autoimmune encephalitis and from control patients with other neurological disorders who lack neuronal antibodies. Researchers will analyze immune responses and search for previously unrecognized autoantibodies, and correlate findings with clinical presentations and outcomes. The protocol includes defined antibody groups (anti-NMDAR, GABABR, AMPAR, LGI1, DNER), seronegative cases, and Susac syndrome for comparison. No experimental treatments are given as part of this observational work.
Why it matters
Potential benefit: If successful, identifying new autoantibodies could speed diagnosis, guide targeted therapies, and help predict disease course.
How similar studies have gone: Previous studies have successfully identified multiple pathogenic neuronal autoantibodies and clarified paraneoplastic mechanisms, so this approach builds on established findings even though discovery of novel antibodies is not guaranteed.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, Rm, Italy Recruiting
Study contacts
- Principal investigator: Raffaele Iorio — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Raffaele Iorio
- Email: raffaele.iorio@policlinicogemelli.it
- Phone: +390630155930
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.