A Multicentric Cohort of Autoimmune Encephalitis

Not yet recruiting

• Conditions: Autoimmune Encephalitis

• Registration Number: NCT06760091
• Lead Sponsor: Xuanwu Hospital, Beijing

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-30
• Study First Submitted QC: 2024-12-30
• Last Update Submitted: 2024-12-30
• Study First Posted: 2025-01-06
• Last Update Posted: 2025-01-06
• Study Start: 2025-02-01
• Primary Completion: 2028-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• 1. Gender and age are not limited; 2. Newly diagnosed autoimmune encephalitis according to at least one of the following three criteria:

  2. According to the criteria of Graus et al in 2016, diagnosed as "definite autoimmune limbic encephalitis"

  3. 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

  4. 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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in modified Rankin score (mRS) from baseline	3months, 6 months, 12months, 24months	Change 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 Outcome Measures

Name	Time	Method
Proportion of Subjects With Occurrence	12 months, 24 months
Change of Clinical Assessment Scale in Autoimmune Encephalitis (CASE) Score from Baseline	3months, 6 months, 12months, 24months	The 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 baseline	3months, 6 months, 12months, 24months

Trial Locations

Locations (1)

Xuanwu Hospital, Capital Medical University; 🇨🇳 Beijing, China