Autoimmune Encephalitis
Conditions
Keywords
autoimmune encephalitis, minocycline
Brief summary
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.
Interventions
DRUGMinocycline
treatment with minocycline combined with first-line drugs for autoimmune encephalitis
Sponsors
Xijing Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of definite autoimmune encephalitis(Graus et al 2016.) 2. Age ≥ 18 years 3. Acute or subacute onset (rapid progression of less than 3 months) 4. Reasonable exclusion of alternative causes 5. Written informed consent
Exclusion criteria
1. Known allergy to tetracycline antibiotics. 2. Pregnant women. 3. Uncontrolled serious concomitant illness. 4. Known chronic kidney disease stages 3b-5. 5. Moderate liver disease (see Child-Pugh for Classification of Severity of Liver Disease). 6. history of cognitive impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Montreal-Cognitive Assessment (MoCA)scores | 3 months | the change in MoCA scores from baseline to 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| modified rankin scale (mRS) scores | 1 month | The proportion of patients achieving a ≥1-point or ≥2-point improvement in mRS scores at 1 month |
| MoCA scores | from baseline to months 1, 6, and 12 | change in MoCA scores from baseline to months 1, 6, and 12 |
| Hamilton anxiety scale (HAMA) scores | from baseline to months 1, 3, 6, and 12 | changes in HAMA scores from baseline to months 1, 3, 6, and 12 |
| Hamilton depression scale (HAMD) scores | from baseline to months 1, 3, 6, and 12 | changes in HAMA scores from baseline to months 1, 3, 6, and 12 |
| mini-mental state examination (MMSE) scores | from baseline to months 1, 3, 6, and 12 | change in MoCA scores from baseline to months 1, 3, 6, and 12 |
Other
| Measure | Time frame | Description |
|---|---|---|
| cerebrospinal fluid (CSF) levels of Soluble Triggering Receptor Expressed on Myeloid cells 2 (sTREM2) | from baseline to months 1, 3, 6, and 12. | the change in CSF levels of sTREM2 levels from baseline to months 1, 3, 6, and 12. |
Countries
China
Outcome results
None listed