Identifying new autoantibodies and causes of autoimmune encephalitis
Study of Pathogenic Mechanisms and Identification of Novel Autoantibodies in Autoimmune Encephalitis Through the Integration of Conventional Methodologies and Advanced Single-cell Technologies
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 |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Rome, RM) |
| Trial ID | NCT07477015 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Rome, RM
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.