Exploration of the Efficacy and Mechanism of Galantamine (an Extract From Lycoris Aurea) in Treating Ischemic Stroke

Official title

Exploration of the Efficacy and Mechanism of Galantamine (an Extract From Lycoris Aurea) in Treating Ischemic Stroke Based on the Neurovascular Unit

Overview

Although mechanical thrombectomy or thrombolytic therapy for large vessels can achieve a revascularization rate (TICI ≥2b) of over 90%, 30-50% of patients still exhibit poor functional outcomes. This phenomenon of "ineffective reperfusion" suggests that microcirculatory dysfunction plays a decisive role in post-stroke neural injury. Therefore, it is necessary to combine brain protection strategies with microcirculatory reperfusion therapy to improve the functional prognosis of stroke patients.Increasing cerebral blood flow (CBF) and neurovascular unit (NVU)-based cerebral protection are current hotspots in the emergency treatment of stroke. Galantamine, extracted from Lycoris aurea (a traditional Chinese medicinal herb), is an acetylcholinesterase inhibitor (AChEI) that has been widely recognized for improving cerebral blood flow and modulating inflammatory responses in ischemic stroke (IS). Therefore, the applicant will conduct an internationally compliant, randomized controlled clinical study with routine treatment to evaluate the efficacy of galantamine in the treatment of acute cerebral infarction. This project will conduct a comprehensive assessment of the drug's efficacy from multiple aspects, including improvements in stroke-related outcomes, Traditional Chinese Medicine (TCM) syndrome manifestations, cognitive function, cerebral blood flow, and inflammatory factors.

Interventions

• Drug Galantamine
  Start within 24 hours of hospitalization, administer 5.0 mg of galantamine via intramuscular injection once daily, and continue the treatment for 10 days.
• Drug Standard treatment for acute ischemic stroke
  Standard treatment for acute ischemic stroke

Primary outcome measures

• The change in NIHSS score [Time frame: Randomization Day,Day 10 (±2 days),Day 30 (±4 days) and Day 90 (±7 days)]

Secondary outcome measures (11)

• Scores assessed by Fugl-Meyer motor assessment (FMA) [Time frame: Randomization Day,Day 10 (±2 days),Day 30 (±4 days) and Day 90 (±7 days)]
• Cerebral Blood Flow [Time frame: Randomization Day,Day 30 (±4 days)]
• Fractional anisotropy (FA) values [Time frame: Randomization Day,Day 30 (±4 days)]
• TNF-α [Time frame: Randomization Day,Day 10 (±2 days)]
• IL-6 [Time frame: Randomization Day,Day 10 (±2 days)]
• Modified Rankin Scale (mRS) score [Time frame: Randomization Day,Day 10 (±2 days),Day 30 (±4 days) and Day 90 (±7 days)]
• Scores assessed by Mini-Mental State Examination (MMSE) [Time frame: Randomization Day,Day 10 (±2 days),Day 30 (±4 days) and Day 90 (±7 days)]
• Scores assessed by Montreal Cognitive Assessment (MoCA) [Time frame: Randomization Day,Day 10 (±2 days),Day 30 (±4 days) and Day 90 (±7 days)]
• Traditional Chinese Medicine (TCM) syndrome manifestations [Time frame: Randomization Day,Day 10 (±2 days),Day 30 (±4 days) and Day 90 (±7 days)]
• Barthel Index Score [Time frame: Randomization Day,Day 10 (±2 days),Day 30 (±4 days) and Day 90 (±7 days)]
• EQ-5D Scale Score [Time frame: Randomization Day,Day 10 (±2 days),Day 30 (±4 days) and Day 90 (±7 days)]

Eligibility criteria

Inclusion criteria

• Aged > 18 years and < 85 years, regardless of gender
• Meeting the diagnostic criteria for ischemic stroke in Western medicine
• Meeting the diagnostic criteria for stroke (Zhongfeng) in Traditional Chinese Medicine (TCM)
• Diagnosis of acute ischemic stroke within 72h of symptom onset
• A score of 4-25 points on the National Institute of Health Stroke Scale (NIHSS)
• First onset of the disease, or no severe sequelae related to previous onset
• The patient and their legal guardian voluntarily sign the informed consent form for the study

Exclusion criteria

• Confirmed by cranial imaging examination to have diseases causing similar symptoms such as brain tumors, encephalitis, and brain abscesses; or confirmed to have hemorrhagic cerebral infarction,epidural hematoma,intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, etc.
• Patients with severe abnormalities of liver and kidney function (liver function: alanine aminotransferase \[ALT\] >2 times the upper limit of normal \[ULN\]; renal function: creatinine \[Cr\]>1.5 times the upper limit of normal \[ULN\])
• Elderly patients with physical weakness or patients complicated with infection
• Patients with a history of mental illness or dementia
• Patients with other severe organ or systemic diseases, accompanied by malignant tumors in any organ or system, or undergoing anti-tumor treatment, with an expected survival time of < 6 months
• A significant history of drug or alcohol abuse
• Women who test positive for blood human chorionic gonadotropin (HCG) (i.e., HCG ≥ 5 mIU/mL) during pregnancy screening, plan to become pregnant during the trial, or are breastfeeding
• Patients who are currently participating in other clinical trials or have participated in other clinical trials within the past 1 month
• Patients who are currently using other cholinesterase inhibitor drugs or have used other cholinesterase inhibitor drugs within the past 3 months
• Patients with epilepsy, hyperkinesis, mechanical intestinal obstruction, bronchial asthma, angina pectoris, bradycardia, or glaucoma
• Patients with contraindications to brain magnetic resonance imaging (MRI) examination, such as patients with implanted cardiac pacemakers, patients with implanted artificial joints or orthopedic plates, patients with claustrophobia, etc

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

China · 1 center

• Shanghai Yueyang Integrated Medicine Hospital — Shanghai

Identifiers

NCT: NCT07003386 · AISCBF2025

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗