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

• Sponsor: Yi Yang (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06140888
• Collaborator: (none)
• Enrollment: 356
• Arms: 2
• Anticipated Duration (Months): 39

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Acute Ischemic Stroke	Drug: Ginkgo Biloba Extract	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 356 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effect of Ginkgo Biloba Extract on Cognitive Function in Acute Ischemic Stroke: a Multicentre, Randomised, Open-label, Blinded-Endpoint Trial
• Anticipated Study Start Date: Jan 1, 2024
• Anticipated Primary Completion Date: Oct 1, 2026
• Anticipated Study Completion Date: Apr 1, 2027

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Changes of the Montreal Cognitive Assessment (MoCA) score [180 days]

   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.

Secondary Outcome Measures

1. Changes of the Mini-Metal State Examination (MMSE) score [180 days]

   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.

2. the Montreal Cognitive Assessment (MoCA) score [180 days]

   MoCA scores range from 0 to 30, with higher MoCA scores indicating better cognitive function.

3. the Mini-Metal State Examination (MMSE) score [180 days]

   MMSE scores range from 0 to 30, with higher MMSE scores indicating better cognitive function.

4. the modified rankin scale (mRS) score [90 days; 180 days]

   mRS Scores range from 0 to 6, with a higher mRS Score indicating a worse prognosis.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Yi Yang

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yi Yang, Associated Dean of the First Hospital of Jilin University, The First Hospital of Jilin University
• ClinicalTrials.gov Identifier: NCT06140888
• Other Study ID Numbers: BEFIT
• First Posted: Nov 20, 2023
• Last Update Posted: Nov 22, 2023
• Last Verified: Nov 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia

Study Results

No Results Posted as of Nov 22, 2023