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

Acute Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06140888
• Other study ID #: BEFIT
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 15, 2024
• Est. completion date: April 1, 2027

Study information

• Verified date: February 2024
• Source: The First Hospital of Jilin University
• Contact: Yi Yang, PhD
• Phone: 13756661217
• Email: doctoryangyi[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 356
• Est. completion date: April 1, 2027
• Est. primary completion date: October 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Drug:
• Ginkgo Biloba Extract
Ginkgo biloba extract 8 pills three times per day is administrated.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yi Yang

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	the Montreal Cognitive Assessment (MoCA) score	MoCA scores range from 0 to 30, with higher MoCA scores indicating better cognitive function.	180 days
Secondary	the Mini-Metal State Examination (MMSE) score	MMSE scores range from 0 to 30, with higher MMSE scores indicating better cognitive function.	180 days
Secondary	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