Who may be eligible for the Risk Prediction Model for Severe Autoimmune Encephalitis trial?

Inclusion Criteria: * age 14-80 years * no restriction on gender * meets the diagnostic criteria for confirmed AE, with a clearly identified pathogenic antibody * within 3 months of AE * patients voluntarily sign the informed consent form; if unable to express their will or sign, the consent form can be signed by a close relative on their behalf Exclusion Criteria: * no lumbar puncture performed for CSF antibody testing * did not receive immunotherapy * pre-onset modified Rankin Scale (mRS) score ≥3

ClinicalTrials.gov record NCT06697678

Risk Prediction Model for Severe Autoimmune Encephalitis

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

Development and Validation of a Risk Prediction Model for Severe Autoimmune Encephalitis

About this page. This page shows the study's official ClinicalTrials.gov record ↗, with added help to make it easier to understand. We explain medical terms, highlight key details in plain language, and suggest questions you may want to ask the study team.

The record is periodically copied from ClinicalTrials.gov and may lag behind changes. AI summaries are checked by software, not a clinician.Read moreShow less

The official record is written by the study sponsor and published on ClinicalTrials.gov. It may not always reflect the latest changes. Before making any decisions, please confirm important information with the study team and your own healthcare team.

Where you see "AI summary", AI was used to create a plain-language explanation and software checked it against the source. It has not been reviewed by a clinician, so it may contain mistakes or leave out important details.

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.

Age14 years old to 80 years old

SexAll

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 multicenter observational study will collect clinical, blood and cerebrospinal fluid data from hospitalized autoimmune encephalitis patients to build a shared database. It aims to find early indicators of severe disease and to develop and validate a prediction model. The study will also analyze immunotherapy regimens, including early plasma exchange/plasma adsorption and targeted immunotherapy, and measure clinical outcomes out to 12 months.

What it is studying. The study is testing whether clinical features, changes in blood and cerebrospinal fluid immune-inflammatory markers, and details of immunotherapy relate to severe disease. It aims to identify early warning signs of severe autoimmune encephalitis and to develop and validate a predictive model that classifies patients by risk of severe disease. It will also examine associations between early plasma exchange/plasma adsorption or targeted immunotherapy and patient outcomes and long-term prognosis.

What the researchers hope to learn. Establish a multicenter clinical database of autoimmune encephalitis; describe clinical and immunologic progression; identify early clinical indicators of severe disease; develop and validate a risk prediction model for severe autoimmune encephalitis; and evaluate associations between early plasma exchange/plasma adsorption and targeted immunotherapy with outcomes and long-term prognosis.

What this study is about

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

A prospective study aims to establish a multicenter clinical diagnosis and treatment database for patients with autoimmune encephalitis (AE). The study will analyze the characteristics of disease progression, changes in immune-inflammatory markers, immunotherapy regimens, and patient outcomes. It seeks to identify clinical indicators for the early recognition of severe AE patients, develop and validate a predictive model for severe AE, and explore effective treatment strategies to rapidly control disease progression during the acute phase of severe AE.

Interventions being studied

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

Other: No Intervention: Observational Cohort

Eligibility

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

Inclusion criteria

age 14-80 years
no restriction on gender
meets the diagnostic criteria for confirmed AE, with a clearly identified pathogenic antibody
within 3 months of AE
patients voluntarily sign the informed consent form; if unable to express their will or sign, the consent form can be signed by a close relative on their behalf

Exclusion criteria

no lumbar puncture performed for CSF antibody testing
did not receive immunotherapy
pre-onset modified Rankin Scale (mRS) score ≥3

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

To develop and validate a predictive model for severe autoimmune encephalitis (AE), a prospective multicenter study will be conducted. Clinical data of hospitalized AE patients will be collected consecutively, and a multicenter integrated database will be established. This database will include information on the characteristics of disease progression, changes in blood and cerebrospinal fluid immune-inflammatory markers, specific immunotherapy regimens, patient outcomes, and long-term prognoses. The study will analyze the clinical and immunological characteristics of AE patients, identify clinical indicators for early recognition of severe AE, and develop and validate a predictive model for severe AE. Additionally, the study will evaluate the efficacy of early plasma exchange/plasma adsorption therapy and targeted immunotherapy on AE outcomes and long-term prognosis, aiming to explore effective treatment strategies for rapidly controlling disease progression in the acute phase of severe AE.

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.

This is an observational study: medical and treatment information will be collected during hospitalization and over follow-up. Blood and CSF immune-inflammatory markers and results of diagnostic tests will be recorded; lumbar puncture (spinal tap) is a key procedure already required for CSF antibody testing. The study team will record the immunotherapy given by the treating doctors (including plasma exchange/plasma adsorption or targeted immunotherapy if used) and will assess clinical outcomes using standard scales at specified timepoints (for example at 1, 2, 6 and 12 months). Participants (or their representatives) will be asked to sign informed consent.

How the study is structured. A prospective observational cohort across multiple centers. Hospitalized patients with antibody-confirmed autoimmune encephalitis are entered into an integrated database and followed with repeated clinical assessments and outcomes measures (including CASE, modified Rankin Scale, and Glasgow Coma Scale) and laboratory testing of blood and cerebrospinal fluid. There is no assigned treatment—patients receive usual care and are analyzed by disease severity and treatments received. Follow-up assessments are planned up to 12 months.

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?
No sites are listed on the registry yet. Where will the study take place?
Which of the eligibility criteria would need to be checked with tests before I could join?

More on autoimmune encephalitis

Clinical trials40 trials listed for autoimmune encephalitisEvery trial the registry lists for autoimmune encephalitis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in autoimmune encephalitis researchLatest monthly update: September 2026. Includes: Efgartigimod reports. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start: Jan 1, 2025 (estimated)
Primary completion: Feb 29, 2028 (estimated)
Study completion: Dec 31, 2028 (estimated)
Target enrollment: 1000 participants (estimated)
Last updated on registry: Dec 27, 2024
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.

Yan Zhang 📞 0086-13671376710 ✉ zhangylq@sina.com

Participating sites

Study locations have not been posted on ClinicalTrials.gov yet. This study is not yet recruiting, so sites may be added when recruitment begins. The central study contact above may be able to tell you about planned sites.

Terms used on this page · explanations by MedicalUpdates.ai

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.
lumbar puncture: A procedure in which a needle is placed between the bones of the lower back to collect spinal fluid or to give a treatment.
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.

← Back to clinical trials