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NCT Number: NCT06760091

A Multicentric Cohort of Autoimmune Encephalitis

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.

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Key information

Conditions

Autoimmune Encephalitis Autoimmune Diseases Autoimmune Diseases of the Nervous System Immune System Diseases Nervous System Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1. 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

Treatment and study plan

baseline data collection and follow-up

Other

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.

Primary outcomes

  1. Change in modified Rankin score (mRS) from baseline

    Time frame: 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 outcomes

  1. Proportion of Subjects With Occurrence

    Time frame: 12 months, 24 months

  2. Change of Clinical Assessment Scale in Autoimmune Encephalitis (CASE) Score from Baseline

    Time frame: 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.

  3. Changes of pathogenic antibody titers from baseline

    Time frame: 3months, 6 months, 12months, 24months

Study contacts

Contact information is provided by the study sponsor or research team.

Junwei Hao, MD; PhD

CONTACT

[email protected]

01083198277

Sponsors and collaborators

Lead sponsor

Xuanwu Hospital, Beijing

Other

Registry information

Official study title

Multicentric Registry Study of Autoimmune Encephalitis

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jan 6, 2025
Registry last updated
Jan 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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