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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: Drug: Ginkgo Biloba Extract

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 356
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yi Yang, PhD; Phone Number: 0086 13756661217; Email: doctoryangyi@163.com
• Study Contact Backup: Name: ZhenNi Guo, PhD; Phone Number: 0086 18186872986; Email: zhen1ni2@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients with a definitive clinical diagnosis of acute ischemic stroke;
2. Age≥18 years, regardless of sex；
3. Primary education level or higher; baseline MoCA score of 10-25 points;
4. Able to complete cognitive scale scoring;
5. Informed consent is signed and ginkgo biloba extract therapy is initiated within 14 days of onset.

Exclusion Criteria:

1. Transient ischemic attack；
2. Patients who received emergency reperfusion therapy (including intravenous thrombolysis and endovascular thrombectomy) at onset;
3. 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；
4. 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)；
5. Had a pre-existing diagnosis of a cognitive disorder；
6. 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；
7. Severe liver and kidney dysfunction;
8. Active ulcer or bleeding diathesis；
9. Allergy to preparations containing ginkgo biloba extract；
10. Pregnant or lactating women, patients with a life expectancy less than 6 months, and those unable to complete the study for other reason；
11. Unwillingness to be followed up or poor treatment compliance;
12. Those who are participating in other clinical investigators, or who have participated in other clinical studies within 3 months prior to enrollment;
13. Other conditions that the investigators deemed unsuitable for enrollment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Yi Yang
• Investigators: Principal Investigator: Yi Yang, PhD, The First Hospital of Jilin University

Study record dates

Study Major Dates

• Study Start (Estimated): March 15, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: November 15, 2023
• First Submitted That Met QC Criteria: November 15, 2023
• First Posted (Actual): November 20, 2023

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 25, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Infarction; Brain Infarction; Stroke; Ischemic Stroke; Ischemia; Cerebral Infarction
• Other Study ID Numbers: BEFIT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No