Efficacy and Safety of Adjunctive Minocycline in the Treatment of Autoimmune Encephalitis

Study Overview
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Brief Summary
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Autoimmune encephalitis (AE) is an immune-mediated brain disorder characterized by varied clinical manifestations that correlate with specific types of antibodies.Typical symptoms include acute behavioral changes, psychosis, seizures, memory deficits, dyskinesias, speech impairments, and autonomic and respiratory dysregulation.While the majority of patients respond well to immunotherapeutic agents, a significant proportion remains resistant to initial and secondary-line immunotherapies.Minocycline, a semisynthetic tetracycline, is notably used for the central nervous system due to its lipophilic characteristics and its capacity to penetrate the blood-brain barrier. While the primary neuroprotective focus of minocycline in the central nervous system remains unknown, the primary effects of minocycline include the inhibition of microglial activation, mitigation of apoptosis, and reduction in reactive oxygen species generation.Protective effect has been observed in hypoxic injury, ischemic stroke, amyotrophic lateral sclerosis, traumatic spinal cord injury, multiple sclerosis, Parkinson's disease, and Huntington's disease.Can minocycline offer a protective role in AE? Consequently, we proposed a randomized, controlled trial to investigate the efficacy of minocycline in AE.

Official Title
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Efficacy and Safety of Adjunctive Minocycline in the Treatment of Autoimmune Encephalitis: Open-lable, Randomised, Proof of Concept Study

Conditions
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Autoimmune Encephalitis

Intervention / Treatment
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* Drug: Minocycline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of definite autoimmune encephalitis(Graus et al 2016.) Age ≥ 18 years Acute or subacute onset (rapid progression of less than 3 months) Reasonable exclusion of alternative causes Written informed consent Exclusion Criteria: Known allergy to tetracycline antibiotics. Pregnant women. Uncontrolled serious concomitant illness. Known chronic kidney disease stages 3b-5. Moderate liver disease (see Child-Pugh for Classification of Severity of Liver Disease). history of cognitive impairment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: Treatment group<br>Drug: Minocyclin 200 mg oral minocycline for a total of 30 days | Drug: Minocycline<br>* treatment with minocycline combined with first/second-line drugs for autoimmune encephalitis<br>* Other names: minocycline hydrochloride;|
| No Intervention: Control group<br>first/second-line drugs for autoimmune encephalitis | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MoCA scores | The proportion of patients with MoCA scores ≥26 at 3 months after enrollment. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mRS scores | The proportion of patients with mRS scores ≤2 at discharge. | 1 month | 
| MoCA scores | The proportion of patients with MoCA scores ≥26 at discharge. | 1 month | 
| MMSE scores | The proportion of patients with MMSE scores ≥27 at discharge. | 1 month | 
| mRS scores | The proportion of patients with mRS scores ≤2 at 3 months. | at 3 months | 
| MMSE scores | The proportion of patients with MMSE scores ≥27 at 3 months. | at 3 months | 
| HAMA scores | HAMA scores at 3 months. | at 3 months | 
| HAMD scores | HAMD scores at 3 months. | at 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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autoimmune encephalitis, minocycline