Clinical trial NCT07003386: Galantamine Improves Motor and Sensory Dysfunction in Patients With Acute Ischemic Stroke
Official title: Clinical Efficacy and Mechanism of Action of Galantamine in Improving Motor and Sensory Dysfunction in Patients With Acute Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Acute Ischemic Stroke AIS
Lead sponsor: Shanghai Yueyang Integrated Medicine Hospital
Sponsor class: OTHER
First posted: 2025-06-04
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

As an acetylcholinesterase inhibitor (AChEI), galantamine has been widely recognized for its role in improving cerebral blood flow in ischemic stroke (IS).

Galantamine has demonstrated good safety in treating sensory and motor dysfunction caused by neurological diseases or trauma. To this end, the applicant will conduct an international-standard, randomized controlled clinical trial with conventional treatment as a comparator to evaluate the efficacy of galantamine in improving motor and sensory dysfunction in patients with acute ischemic stroke (AIS).


Eligibility criteria: Inclusion Criteria:

* 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)
* The mRS score before stroke is 0-1
* Patient and family members sign informed consent

Exclusion Criteria:

* Cranial imaging examinations confirm the presence of diseases causing similar symptoms such as brain tumors, encephalitis, brain abscess, etc., or confirm hemorrhagic cerebral infarction, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, etc
* Patients with active bleeding or bleeding tendency, malignancies, severe liver (the serum level of AST and/or ALT \> 2 times the upper limit of normal), or renal failure (the serum level of creatinine \> 1.5 times the upper limit of normal or GFR \< 40 ml/min/1.73m2)
* Elderly people with weak constitutions or patients complicated with infections
* Patients with a history of mental illness or severe dementia
* A significant history of drug or alcohol abuse
* Allergic constitution, or allergic to two or more drugs or foods
* Pregnancy, lactation, or planning to get pregnant
* Patients who are currently participating in or have participated in other clinical trials within the past 1 month
* Currently using or having used other cholinesterase inhibitor drugs within the past 3 months
* Having taken galantamine within 1 month before randomization, or being required to take galantamine for other diseases within the next 90 days
* Patients with epilepsy, hyperkinesia, mechanical intestinal obstruction, bronchial asthma, angina pectoris, bradycardia, or glaucoma
* Individuals with contraindications to MRI examination
* Individuals who are allergic to the ingredients of the administered drug

Primary outcomes:
measure: The change in NIHSS score from admission to discharge (ΔNIHSS=NIHSS score at discharge-NIHSS score at admission)
timeFrame: 24 hours and day 10
Secondary outcomes:
measure: Scores assessed by Fugl-Meyer motor assessment (FMA)
timeFrame: 24 hours,10 days
measure: Cerebral Blood Flow
timeFrame: 24 hours,10 days
measure: Fractional anisotropy (FA) values
timeFrame: 24 hours,10 days
measure: TNF-α
timeFrame: 24 hours,10 days
measure: IL-6
timeFrame: 24 hours,10 days
measure: Modified Rankin Scale (mRS) score
timeFrame: 24 hours,10 days,90±14 days after randomization
measure: Scores assessed by Mini-Mental State Examination (MMSE)
timeFrame: 24 hours,10 days,90±14 days after randomization
measure: Scores assessed by Montreal Cognitive Assessment (MoCA)
timeFrame: 24 hours,10 days,90±14 days after randomization
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Yueyang Integrated Medicine Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Yueyang Integrated Medicine Hospital
name: Jia Zhou
role: STUDY_CHAIR
References: