Effect of Ginkgo Biloba Extract on Cognitive Function in Acute Ischemic Stroke

Study Overview
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Brief Summary
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The purpose of this study is to determine the effect of ginkgo biloba extract on cognitive function in acute ischemic stroke.

Detailed Description
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Vascular brain injury is a common post-stroke complication that can reduce cognitive function and lead to vascular cognitive impairment, placing a significant burden on families and society. The purpose of this study is to determine the effect of ginkgo biloba extract on cognitive function in acute ischemic stroke.

Official Title
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Effect of Ginkgo Biloba Extract on Cognitive Function in Acute Ischemic Stroke: a Multicentre, Randomised, Open-label, Blinded-Endpoint Trial

Conditions
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Acute Ischemic Stroke

Intervention / Treatment
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* Drug: Ginkgo Biloba Extract


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a definitive clinical diagnosis of acute ischemic stroke; Age≥18 years, regardless of sex； Primary education level or higher; baseline MoCA score of 10-25 points; Able to complete cognitive scale scoring; Informed consent is signed and ginkgo biloba extract therapy is initiated within 14 days of onset. Exclusion Criteria: Transient ischemic attack； Patients who received emergency reperfusion therapy (including intravenous thrombolysis and endovascular thrombectomy) at onset; Combined with other neurological diseases, such as neurodegenerative diseases (e.g., Alzheimer's disease, Parkinson's disease, Lewy body dementia, and frontotemporal dementia), optic neuritis, epilepsy, central nervous system infections (e.g., AIDS and syphilis), traumatic brain injury dementia, etc； Currently using psychoactive medications (e.g., antidepressants) or anti-epileptic drugs, or if the time since their last use of these medications was less than 5 half-lives (per the pharmacokinetics of each specific medication; for drugs with unknown half-lives, a 1 month washout period was required)； Had a pre-existing diagnosis of a cognitive disorder； Currently taking medications intended to improve cognitive function or prevent dementia (e.g., cholinesterase inhibitors, memantine, nootropics), or if the washout period since their last use of these medications was less than 5 half-lives as specified in each drug's pharmacokinetics. For drugs with unknown half-lives, a minimum 1 month washout period was required； Severe liver and kidney dysfunction; Active ulcer or bleeding diathesis； Allergy to preparations containing ginkgo biloba extract； Pregnant or lactating women, patients with a life expectancy less than 6 months, and those unable to complete the study for other reason； Unwillingness to be followed up or poor treatment compliance; Those who are participating in other clinical investigators, or who have participated in other clinical studies within 3 months prior to enrollment; Other conditions that the investigators deemed unsuitable for enrollment.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The ginkgo biloba extract group<br>Ginkgo biloba extract 8 pills three times per day is administrated. | Drug: Ginkgo Biloba Extract<br>* Ginkgo biloba extract 8 pills three times per day is administrated.<br>|
| No Intervention: The control group<br>Standard medical therapy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of the Montreal Cognitive Assessment (MoCA) score | The MoCA scores in the 180 day of treatment minus baseline MoCA scores. MoCA scores range from 0 to 30, with higher MoCA scores indicating better cognitive function. | 180 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of the Mini-Metal State Examination (MMSE) score | The MMSE scores in the 180 day of treatment minus baseline MMSE scores. MMSE scores range from 0 to 30, with higher MMSE scores indicating better cognitive function. | 180 days | 
| the Montreal Cognitive Assessment (MoCA) score | MoCA scores range from 0 to 30, with higher MoCA scores indicating better cognitive function. | 180 days | 
| the Mini-Metal State Examination (MMSE) score | MMSE scores range from 0 to 30, with higher MMSE scores indicating better cognitive function. | 180 days | 
| the modified rankin scale (mRS) score | mRS Scores range from 0 to 6, with a higher mRS Score indicating a worse prognosis. | 90 days; 180 days |