ClinicalTrials.gov record NCT06760091

A Multicentric Cohort of Autoimmune Encephalitis

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

Multicentric Registry Study of Autoimmune Encephalitis

StatusNot yet recruitingThe study has been registered but has not started enrolling. Sites and contacts may not be listed yet.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
SexAll
LocationChina
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This prospective observational cohort enrolls people with newly diagnosed autoimmune encephalitis or paraneoplastic neurological syndrome. It collects clinical information, biological samples, and imaging at baseline and follows participants for two years with face-to-face, telephone, or online visits to record outcomes. The study aims to describe prognosis across subtypes and subgroups (for example epilepsy and teratoma subgroups) and to search for blood and imaging biomarkers related to outcomes.

What it is studying. The study is building a multicenter cohort to observe how people with autoimmune encephalitis fare over time and to look for blood and imaging biomarkers that are associated with clinical outcomes across different subtypes and subgroups.

What the researchers hope to learn. To establish a multicenter cohort of autoimmune encephalitis patients; to describe clinical course and prognosis in different subtypes and subgroups; to collect clinical, sample, and imaging data to discover blood and imaging biomarkers that could inform future research on treatment, early warning, and outcome prediction.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

This study aims to establish an autoimmune encephalitis cohort and observe the prognosis of patients with different subtypes and subgroups (e.g. epilepsy subgroup and teratoma subgroup ). Clinical characteristics, biological samples, and imaging data will be collected to discover blood and imaging biomarkers for providing support for the treatment, early warning, and outcome prediction.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Other
  • baseline data collection and follow-up

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • Gender and age are not limited; 2. Newly diagnosed autoimmune encephalitis according to at least one of the following three criteria:
  • According to the criteria of Graus et al in 2016, diagnosed as "definite autoimmune limbic encephalitis"
  • According to the criteria of Graus et al in 2016, diagnosed as "possible autoimmune encephalitis" and typical autoantibodies are detected in serum or cerebrospinal fluid
  • According to the criteria of Graus et al in 2021, diagnosed as "possible or definite paraneoplastic neurological syndrome" (excluding peripheral nervous system syndrome) 3. The patient or legal representative voluntarily signed the paper informed consent form.
  • Additional inclusion criteria for patients in the epilepsy subgroup: patients diagnosed with epilepsy secondary to autoimmune encephalitis.

Exclusion criteria

  • No additional exclusion criteria

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants give baseline information and the study collects clinical information, biological samples, and imaging data. Each person is followed for 2 years with face-to-face, telephone, or online visits and their clinical prognosis is recorded. Follow-up assessments include disability and disease-severity measures (for example the modified Rankin Scale and the CASE score) and measurements of pathogenic antibody levels at multiple timepoints up to 24 months.

How the study is structured. Prospective observational cohort: baseline data collection at enrollment, then scheduled follow-up visits over 24 months (by in-person, phone, or online). Clinical outcome measures (for example the modified Rankin Scale and the CASE score) and antibody titers are recorded at set times (including months 1, 3, 6, 12, and 24). No experimental treatment is assigned.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The registry says recruitment has not started. When is it expected to open, and can I register interest now?
  • The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on autoimmune encephalitis

Important dates

Study start
Feb 1, 2025 (estimated)
Primary completion
Dec 31, 2028 (estimated)
Study completion
Dec 31, 2028 (estimated)
Target enrollment
200 participants (estimated)
Last updated on registry
Jan 6, 2025
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Xuanwu Hospital, Beijing

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

cohort
A group of people who share a characteristic, such as a diagnosis, and are studied together. 'Prospective' means they are followed forward from enrolment; 'retrospective' means existing records are reviewed.
biomarkers
Something measurable in the body, such as a blood test result or an imaging finding, that indicates how a condition or treatment is behaving.
legal representative
A person who is legally allowed to make decisions, including consent to research, on behalf of someone who cannot consent for themselves.
informed consent form
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
inclusion criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
exclusion criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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