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

NCT07003386 | Recruiting Phase 2

• 1 other identifier: AISCBF2025
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• The change in NIHSS score

  Scores on the National Institutes of Health Stroke Scale (NIHSS) range from 0 to 42, with higher scores indicating more severe neurologic deficits

  Randomization Day,Day 10 (±2 days),Day 30 (±4 days) and Day 90 (±7 days)

Secondary Outcomes (11)

• Scores assessed by Fugl-Meyer motor assessment (FMA)

  Randomization Day,Day 10 (±2 days),Day 30 (±4 days) and Day 90 (±7 days)

• Cerebral Blood Flow

  Randomization Day,Day 30 (±4 days)

• Fractional anisotropy (FA) values

  Randomization Day,Day 30 (±4 days)

• TNF-α

  Randomization Day,Day 10 (±2 days)

• IL-6

  Randomization Day,Day 10 (±2 days)

Study Arms (2)

galantamine group

EXPERIMENTAL

Standard treatment for acute ischemic stroke and galantamine

Drug: Galantamine; Drug: Standard treatment for acute ischemic stroke

Control group

SHAM COMPARATOR

Standard treatment for acute ischemic stroke

Drug: Standard treatment for acute ischemic stroke

Interventions

Galantamine DRUG

Start within 24 hours of hospitalization, administer 5.0 mg of galantamine via intramuscular injection once daily, and continue the treatment for 10 days.

Also known as: Galantamine from Lycoris aurea extract

galantamine group

Standard treatment for acute ischemic stroke DRUG

Standard treatment for acute ischemic stroke

Also known as: Routine Western medical treatment according to guidelines

Control group; galantamine group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Yueyang Integrated Medicine Hospital: lead

Study Sites (1)

Shanghai Yueyang Integrated Medicine Hospital

Shanghai, Shanghai Municipality, 200080, China

RECRUITING

MeSH Terms

Interventions

Galantamine

Intervention Hierarchy (Ancestors)

Amaryllidaceae Alkaloids; Alkaloids; Heterocyclic Compounds; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Chunxiang Chen

  Shanghai Yueyang Integrated Medicine Hospital

  STUDY CHAIR

Central Study Contacts

Chunxiang Chen

CONTACT

+8618616537797; 768449109@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: June 4, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): September 14, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: September 16, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)