Acute Ischemic Stroke AISPhase 2/3NCT07003386
Exploration of the Efficacy and Mechanism of Galantamine (an Extract From Lycoris Aurea) in Treating Ischemic Stroke
A Phase 2/3 study testing Galantamine and Standard treatment for acute ischemic stroke in people with Acute Ischemic Stroke AIS, run by Shanghai Yueyang Integrated Medicine Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Ischemic Stroke AIS
- What is being tested?
- Galantamine and Standard treatment for acute ischemic stroke
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2025to 30 Sep 2028
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Yueyang Integrated Medicine Hospital
Shanghai, Shanghai Municipality, 200080
Chunxiang Chen, +8618616537797, 768449109@qq.com
About this study
Official title: Exploration of the Efficacy and Mechanism of Galantamine (an Extract From Lycoris Aurea) in Treating Ischemic Stroke Based on the Neurovascular Unit
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
- Being tested
- Galantamine, Standard treatment for acute ischemic stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GalantamineDrug
Also called Galantamine from Lycoris aurea extract
Start within 24 hours of hospitalization, administer 5.0 mg of galantamine via intramuscular injection once daily, and continue the treatment for 10 days.
Standard treatment for acute ischemic strokeDrug
Also called Routine Western medical treatment according to guidelines
Standard treatment for acute ischemic stroke
| Study group | Role | What they receive |
|---|---|---|
| galantamine group | Experimental | Standard treatment for acute ischemic stroke and galantamine Receives: Drug: Galantamine; Drug: Standard treatment for acute ischemic stroke |
| Control group | Sham comparator | Standard treatment for acute ischemic stroke Receives: Drug: Standard treatment for acute ischemic stroke |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Scores on the Fugl-Meyer motor assessment (FMA) range from 0 to 100,with lower scores indicating more severe the motor dysfunction
Measured: Randomization Day,Day 10 (±2 days),Day 30 (±4 days) and Day 90 (±7 days)
Cerebral Blood Flow
The cerebral blood flow is evaluated by MRI
Measured: Randomization Day,Day 30 (±4 days)
Fractional anisotropy (FA) values
The fractional anisotropy (FA) values is evaluated by MRI
Measured: Randomization Day,Day 30 (±4 days)
TNF-α
Laboratory parameters obtained through venous blood analysis
Measured: Randomization Day,Day 10 (±2 days)
IL-6
Laboratory parameters obtained through venous blood analysis
Measured: Randomization Day,Day 10 (±2 days)
Modified Rankin Scale (mRS) score
The mRs is an ordinal disability score of 7 categories (0=no symptoms to 5=severe disability, and 6=death)
Measured: Randomization Day,Day 10 (±2 days),Day 30 (±4 days) and Day 90 (±7 days)
Scores assessed by Mini-Mental State Examination (MMSE)
The MMSE is a brief 30-point questionnaire test that is used to screen for cognitive impairment. A score greater than or equal to 25 points is effectively normal (intact). Below this, scores can indicate severe (≤9 points), moderate (10-20 points) or mild (21-24 points) cognitive impairment
Measured: Randomization Day,Day 10 (±2 days),Day 30 (±4 days) and Day 90 (±7 days)
Scores assessed by Montreal Cognitive Assessment (MoCA)
MoCA scores range between 0 and 30. Higher scores indicate a better outcome, and a score of 26 or over is considered to be normal
Measured: Randomization Day,Day 10 (±2 days),Day 30 (±4 days) and Day 90 (±7 days)
Traditional Chinese Medicine (TCM) syndrome manifestations
Under the guidance of Traditional Chinese Medicine (TCM) theory, evaluate the drug's effect on improving TCM syndrome manifestations (such as hemiplegia, deviated mouth and tongue, and speech impairment).
Measured: Randomization Day,Day 10 (±2 days),Day 30 (±4 days) and Day 90 (±7 days)
Barthel Index Score
It is used to measure the ability of patients (especially those with stroke, geriatric diseases, or in the rehabilitation period) to independently complete daily activities such as eating, dressing, walking, and using the toilet. The scoring range is 0-100 points, with higher scores indicating stronger self-care ability in daily life.
Measured: Randomization Day,Day 10 (±2 days),Day 30 (±4 days) and Day 90 (±7 days)
EQ-5D Scale Score
It is an internationally accepted assessment tool for "Health-Related Quality of Life (HRQoL)". Its core function is to quantitatively evaluate an individual's health status and quality of life through five dimensions: "mobility, self-care, usual activities, pain/discomfort, and anxiety/depression". It is widely used in clinical trials, health economics research, and chronic disease management (e.g., comprehensive evaluation of treatment effects in stroke patients).
Measured: Randomization Day,Day 10 (±2 days),Day 30 (±4 days) and Day 90 (±7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start15 Sep 2025 (estimated)
- Primary completion14 Sep 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic Stroke AISStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Yueyang Integrated Medicine Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chunxiang Chen, Study chair, Shanghai Yueyang Integrated Medicine Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07003386
- Sponsor's protocol ID
- AISCBF2025
- Status last verified
- Aug 2025
- First submitted
- 26 May 2025
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of the Efficacy and Mechanism of Galantamine (an Extract From Lycoris Aurea) in Treating Ischemic Stroke Based on the Neurovascular Unit
- ClinicalTrials.gov ID
- NCT07003386
- Acronym / sponsor ID
- AISCBF2025
- Conditions
- Acute Ischemic Stroke AIS
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Shanghai Yueyang Integrated Medicine HospitalUniversity, hospital or other
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- 14 Sep 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 4 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| galantamine group | Experimental | Drug: Galantamine, Drug: Standard treatment for acute ischemic strokeStandard treatment for acute ischemic stroke and galantamine |
| Control group | Sham comparator | Drug: Standard treatment for acute ischemic strokeStandard treatment for acute ischemic stroke |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GalantamineAlso: Galantamine from Lycoris aurea extractStart within 24 hours of hospitalization, administer 5.0 mg of galantamine via intramuscular injection once daily, and continue the treatment for 10 days. | Drug | galantamine group |
| Standard treatment for acute ischemic strokeAlso: Routine Western medical treatment according to guidelinesStandard treatment for acute ischemic stroke | Drug | Control group, galantamine group |
Primary outcome
The change in NIHSS score
Time frame: Randomization Day,Day 10 (±2 days),Day 30 (±4 days) and Day 90 (±7 days)
Scores on the National Institutes of Health Stroke Scale (NIHSS) range from 0 to 42, with higher scores indicating more severe neurologic deficits
11 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chunxiang Chen study chair
Shanghai Yueyang Integrated Medicine Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Galantamine and Standard treatment for acute ischemic stroke in people with Acute Ischemic Stroke AIS, run by Shanghai Yueyang Integrated Medicine Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chunxiang Chen (+8618616537797, 768449109@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in NIHSS score (time frame: Randomization Day,Day 10 (±2 days),Day 30 (±4 days) and Day 90 (±7 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.