Xijing Hospital
Xi'an, China
NCT Number: NCT06033846
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 2
Xi'an, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
treatment with minocycline combined with first-line drugs for autoimmune encephalitis
Other names: minocycline hydrochloride
Time frame: 3 months
the change in MoCA scores from baseline to 3 months
Time frame: 1 month
The proportion of patients achieving a ≥1-point or ≥2-point improvement in mRS scores at 1 month
Time frame: from baseline to months 1, 6, and 12
change in MoCA scores from baseline to months 1, 6, and 12
Time frame: from baseline to months 1, 3, 6, and 12
change in MoCA scores from baseline to months 1, 3, 6, and 12
Time frame: from baseline to months 1, 3, 6, and 12
changes in HAMA scores from baseline to months 1, 3, 6, and 12
Time frame: from baseline to months 1, 3, 6, and 12
changes in HAMA scores from baseline to months 1, 3, 6, and 12
Time frame: 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.
Xijing Hospital
Other
Efficacy and Safety of Adjunctive Minocycline in the Treatment of Autoimmune Encephalitis: Open-lable, Randomised, Proof of Concept Study
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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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