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A Multicentric Cohort of Autoimmune Encephalitis

Multicentric Registry Study of Autoimmune Encephalitis

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06760091
Enrollment
200
Registered
2025-01-06
Start date
2025-02-01
Completion date
2028-12-31
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autoimmune Encephalitis

Brief summary

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

OTHERbaseline data collection and follow-up

At the time of enrollment, baseline characteristics will be collected, and each subject will be followed up for 2 years through face-to-face, telephone, or online visits. During the follow-up period, the clinical prognosis will be recorded.

Sponsors

Xuanwu Hospital, Beijing
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* 1\. Gender and age are not limited; 2. Newly diagnosed autoimmune encephalitis according to at least one of the following three criteria: 1. According to the criteria of Graus et al in 2016, diagnosed as definite autoimmune limbic encephalitis 2. 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 3. 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

Design outcomes

Primary

MeasureTime frameDescription
Change in modified Rankin score (mRS) from baseline3months, 6 months, 12months, 24monthsChange in modified Rankin score (mRS) from baseline at month 1, month 3, month 6(mRS : Minimum Score 0, Maximum score 6, higher scores mean a worse outcome).

Secondary

MeasureTime frameDescription
Proportion of Subjects With Occurrence12 months, 24 months
Change of Clinical Assessment Scale in Autoimmune Encephalitis (CASE) Score from Baseline3months, 6 months, 12months, 24monthsThe Clinical Assessment Scale in Autoimmune Encephalitis (CASE) score is designed specifically to assess the severity of autoimmune disease. It is a general scoring system ranging from 0 to 27 and can be used as an alternative tool to assess the severity of patients with AE more accurately. Higher scores mean a worse clinical status.
Changes of pathogenic antibody titers from baseline3months, 6 months, 12months, 24months

Countries

China

Contacts

Primary ContactJunwei Hao, MD; PhD
haojunwei@vip.163.com01083198277

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026