NCT07003386

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

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

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: Shanghai Yueyang Integrated Medicine Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Acute Ischemic Stroke AIS

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-09-15
• Primary completion: 2028-09-14
• Completion: 2028-09-30
• First posted: 2025-06-04
• Last updated: 2025-09-16

Locations

1 site across 1 country: China