Galantamine for improving recovery after acute ischemic stroke
Exploration of the Efficacy and Mechanism of Galantamine (an Extract From Lycoris Aurea) in Treating Ischemic Stroke Based on the Neurovascular Unit
This trial will test whether adding galantamine to standard care helps adults with acute ischemic stroke who are treated within 72 hours recover better.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Shanghai Yueyang Integrated Medicine Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT07003386 on ClinicalTrials.gov |
What this trial studies
This is a randomized, phase 2/3 trial comparing galantamine plus standard acute ischemic stroke treatment versus standard treatment alone in adults. Eligible patients are 18–85 years old with ischemic stroke onset within 72 hours and NIHSS scores of 4–25. The rationale is that galantamine, an acetylcholinesterase inhibitor, may increase cerebral blood flow and reduce neuroinflammation to protect the neurovascular unit and improve microcirculatory reperfusion. The trial will measure functional recovery and safety outcomes to determine whether adding galantamine improves patient prognosis after reperfusion therapies.
Who should consider this trial
Good fit: Adults aged 18–85 with a confirmed acute ischemic stroke within 72 hours of symptom onset, NIHSS 4–25, first onset or without severe prior sequelae, who can provide informed consent are ideal candidates.
Not a fit: Patients with hemorrhagic brain lesions, severe liver or kidney dysfunction, or other exclusion conditions — or those treated beyond 72 hours or outside the NIHSS range — are unlikely to benefit or are ineligible for this trial.
Why it matters
Potential benefit: If successful, adding galantamine could improve functional recovery and reduce disability after acute ischemic stroke by enhancing microcirculatory reperfusion and neurovascular protection.
How similar studies have performed: Preclinical data and small clinical reports suggest acetylcholinesterase inhibitors like galantamine may improve cerebral blood flow and modulate inflammation, but large randomized trials in acute ischemic stroke are lacking.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Shanghai, Shanghai Municipality
- Shanghai Yueyang Integrated Medicine Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Chunxiang Chen
- Email: 768449109@qq.com
- Phone: +8618616537797
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.