Galantamine for improving recovery after acute ischemic stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Shanghai Yueyang Integrated Medicine Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Chunxiang Chen
• Email: 768449109@qq.com
• Phone: +8618616537797

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.