A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment

NCT07220538 | Recruiting Phase 4

• 2 other identifiers: D.01.02.2.04ChiCTR2500107051
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 30

Brief Summary

The goal of this clinical trial is to learn if Extract of Ginkgo Biloba Leaves Tablets help improve thinking and memory in people aged 55 years and older who had an ischemic stroke (a type of stroke caused by a blocked blood vessel in the brain). It will also look at how safe the Extract of Ginkgo Biloba Leaves Tablets are. The main questions it aims to answer are:

• Do the Extract of Ginkgo Biloba Leaves Tablets help people with memory or thinking problems after an ischemic stroke?
• What medical problems do people have when taking the Extract of Ginkgo Biloba Leaves Tablets ? Researchers will compare people who take the Extract of Ginkgo Biloba Leaves Tablets along with their usual post-stroke treatment to people who only receive their usual post-stroke treatment. Participants will:
• Have had an ischemic stroke confirmed by MRI (Magnet Resonance Imaging, a magnetic scan that helps seeing inside the body in great detail) 7 to 14 days before joining the study
• Take Extract of Ginkgo Biloba Leaves Tablets (240 mg per day) in addition to usual post-stroke treatment for 12 months, or receive only usual post-stroke treatment for 12 months
• Be treated initially at hospitals across China
• Visit the clinic 4, 26, and 52 weeks following the baseline for checkups and tests, and receive follow-up calls after 12 and 38 weeks.

Conditions

Impairment, Cognitive; Ischemic Stroke Hospitalized

Keywords

Acute ischemic stroke; Cognitive Impairment

Outcome Measures

Primary Outcomes (8)

• Change in Montreal Cognitive Assessment (MoCA) Total Score

  The Montreal Cognitive Assessment (MoCA) is a validated screening tool for mild cognitive impairment. It assesses multiple cognitive domains including attention, executive functions, memory, language, visuospatial skills, conceptual thinking, calculation, and orientation. The test takes approximately 10 minutes to administer and is scored out of a maximum of 30 points. The total score is calculated by summing all sub-item scores, with an additional 1 point added for individuals with ≤12 years of education (maximum score remains 30). Higher scores indicate better cognitive performance. A score below 23 for individuals with ≤12 years of education, or below 22 for those with \>12 years of education, is considered indicative of cognitive impairment \[Wu et al., 2013\].

  From baseline to Week 26 (Visit 4) and Week 52 (Visit 6)

• Change in Cognitive Function Using Trail Making Test (TMT) Parts A and B

  The Trail Making Test (TMT) is a neuropsychological assessment that provides information on visual search, scanning, processing speed, mental flexibility, and executive functioning. It consists of two parts. Both parts consist of 25 circles distributed over a sheet of paper. In Part A, the circles are numbered 1 - 25, and the patient should draw lines to connect the numbers in ascending order. In Part B, the circles include both Arabic numerals (1 - 13) and Chinese numerals as in Part A. he test is administered on paper, and participants are instructed to complete the task as quickly and accurately as possible without lifting the pen. Performance is measured in seconds.

  Change from baseline to Week 26 (Visit 4) and Week 52 (Visit 6)

• Change in Cognitive Processing Speed Using Symbol Digit Modalities Test (SDMT)

  The Symbol Digit Modalities Test (SDMT) is a validated neuropsychological test used to assess cognitive processing speed, attention, and visual-motor coordination. Participants are presented with a series of symbols, each paired with a digit, and are asked to match as many symbols to their corresponding digits as possible within a fixed time period (typically 90 seconds). Performance is measured by the number of correct symbol-digit matches completed (maximum 110). Higher scores indicate better cognitive processing speed and attention

  Change from baseline to Week 26 (Visit 4) and Week 52 (Visit 6)

• Change in Verbal Fluency Performance Using Verbal Fluency Test (VFT)

  The VFT tests the verbal fluency, the patient is asked to name as many examples of one category, e.g. "fruits", "vegetables", "animal", as possible within one minute. Performance is assessed by counting the number of correct, non-repeated words, along with the number of errors, including incorrect responses and repetitions, which contribute to the total score. Higher scores indicate better verbal fluency and cognitive function.

  Change from baseline to Week 26 (Visit 4) and Week 52 (Visit 6)

• Change in Clinical Global Impression of Change Using ADCS-CGIC (Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change)

  The Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) is a validated clinician-rated instrument used to assess overall change in a participant's cognitive, functional, and behavioral status over time. It is based on a structured interview with both the participant and caregiver, incorporating clinical judgment and observation. The ADCS-CGIC uses a 7-point scale to rate change from baseline: 1. \- Marked improvement 2. \- Moderate improvement 3. \- Minimal improvement 4. \- No change 5. \- Minimal worsening 6. \- Moderate worsening 7. \- Marked worsening Lower scores indicate improvement, while higher scores reflect deterioration.

  Change from baseline to Week 26 (Visit 4) and Week 52 (Visit 6)

• Change in Neurological Impairment Using National Institutes of Health Stroke Scale (NIHSS)

  The National Institutes of Health Stroke Scale (NIHSS) is a standardized tool used to assess the severity of neurological deficits in patients following a stroke. It consists of 11 items evaluating functions such as consciousness, vision, motor skills, sensation, language, and attention. Each item is scored individually, and the total score ranges from 0 to 42, with higher scores indicating more severe neurological impairment. A decrease in score over time reflects improvement in neurological function, while an increase indicates worsening impairment.

  Change from Baseline to Week 4 (Visit 1), Week 26 (Visit 4) and Week 52 (Visit 6)

• Change in Neurological Impairment Using Modified Rankin Scale (mRS)

  The Modified Rankin Scale (mRS) is a clinical tool for measuring the degree of disability or dependence in daily activities of people who have suffered a stroke. It assesses functional recovery and neurological impairment on a scale ranging from 0 to 6: 0 - No symptoms at all 1. \- No significant disability despite symptoms; able to carry out all usual duties and activities 2. \- Slight disability; unable to carry out all previous activities but able to look after own affairs without assistance 3. \- Moderate disability; requiring some help, but able to walk without assistance 4. \- Moderately severe disability; unable to walk without assistance, and unable to attend to own bodily needs without assistance 5. \- Severe disability: bedridden, incontinent, and requiring constant nursing care and attention 6. \- Dead Lower scores indicate better functional outcomes.

  Change from Baseline to Week 4 (Visit 1), Week 26 (Visit 4) and Week 52 (Visit 6)

• Any new stroke event (ischemic stroke or hemorrhagic stroke) at Week 4, Week 12, Week 26, Week 38 and Week 52.

  Week 4, Week 12, Week 26, Week 38 and Week 52

Other Outcomes (1)

• Incidence and Nature of Adverse Events, Adverse Drug Reactions, and Serious Adverse Events [Safety Assessment]

  up to 52 weeks

Study Arms (2)

Extract of Ginkgo Biloba Leaves Tablets 240 mg (2 x 40 mg, t.i.d.) add-on to standard of care

EXPERIMENTAL

Extract of Ginkgo Biloba Leaves Tablets 240 mg (2 x 40 mg, t.i.d.) add-on to standard of care

Drug: Extract of Ginkgo Biloba Leaves Tablets 240 mg (2 x 40 mg, t.i.d.)

Standard of Care

SHAM COMPARATOR

Standard of Care (SoC) Group

Other: Standard of care (SoC) Group

Interventions

Standard of care (SoC) Group OTHER

Individualized therapy in accordance with treatment guideline from the Chinese Stroke Association

Standard of Care

Extract of Ginkgo Biloba Leaves Tablets 240 mg (2 x 40 mg, t.i.d.) DRUG

3 x 2 film-coated tablets with 40 mg Extract of Ginkgo Biloba Leaves Tablets daily for 52 weeks plus standard of care in accordance with treatment guidelines

Extract of Ginkgo Biloba Leaves Tablets 240 mg (2 x 40 mg, t.i.d.) add-on to standard of care

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female participants aged ≥ 55 years who gave their informed consent.
• Non-disabling overt acute ischemic stroke (NIHSS (National Institutes of Health Stroke Scale) ≤ 5, mRS (Modified Rankin Scale) ≤ 2 at the day of screening) confirmed by magnetic resonance imaging, and at least 7 but no longer than 14 days before baseline.
• Cognitive impairment (MoCA (Montreal Cognitive Assessment)) total score (corrected) \< 23 for participants with up to 12 years of education, or MoCA total score \< 22 if more than 12 years of education).
• Sufficient Chinese language skills to understand and respond to all interview questions, complete questionnaires and undergo neuropsychological testing.

You may not qualify if:

• Participation in another experimental drug trial at the same time or within the past 4 weeks before enrollment.
• Aphasia, dysarthria, apraxia or paresis of the dominant upper extremity, severe and insufficiently corrected loss of vision or hearing, severe language difficulties or any other disability that may prevent the participant from cooperating adequately in the trial or that may interfere with neuropsychological test performance.
• Pre-stroke cognitive impairment (16-item Informant Questionnaire on Cognitive Decline (IQCODE) score ≥ 3.3), preexisting major neurocognitive disorder (e. g., dementia due to Alzheimer's disease, vascular dementia, dementia with Lewy bodies, frontotemporal dementia).
• Cardiogenic ischemic stroke, atrial fibrillation, or any other conditions that require the intake of anticoagulants.
• Conditions that require the administration of thrombolytics at day of Screening or Visit 1.
• Index acute ischemic stroke with hemorrhagic transformation.
• Intake of traditional Chinese medicines.
• Major neurological disorder, including intracranial hemorrhage, delirium, Parkinson's disease, brain tumor, alcohol-associated brain damage, infectious CNS disease, epilepsy, recent brain trauma, subdural hematoma, HIV-associated cognitive disorder, Huntington's disease, Pick's disease, Wilson's disease, normal pressure hydrocephalus, hydrocephalus, progressive supra-nuclear palsy, Creutzfeldt-Jakob disease, etc.
• Major depression or generalized anxiety disorder.
• Active malignant disease.
• Alcohol addiction or substance abuse.
• Known hypersensitivity to Ginkgo biloba, Ginkgo biloba extract or any ingredient of the drug under trial.
• Any circumstances that prevent the participant to be followed up at the scheduled intervals. Hospitalization of the participant for long-term treatment or nursing home placement for bedside care (assisted living facility residence or stay in a rehabilitation facility is acceptable if the participant is not bedridden and does not need general bedside nursing, and if an informant is available who sees the participant on a regular basis and accompanies him/her to the trial visits).
• Severe comorbidity with life expectancy \< 12 months.

Sponsors & Collaborators

• Dr. Willmar Schwabe GmbH & Co. KG: lead
• Beijing Tiantan Hospital: collaborator

Study Sites (30)

The People's Hospital of Anyang City

Anyang, China

RECRUITING

Baotou Central Hospital

Baotou, China

RECRUITING

Tiantan Hospital

Beijing, China

RECRUITING

Beipiao Central Hospital

Beipiao, China

RECRUITING

Benxi Central Hospital

Benxi, China

RECRUITING

The First People's Hospital of Chenzhou

Chenzhou, China

RECRUITING

Affiliated Hospital of Chifeng University

Chifeng, China

ACTIVE NOT RECRUITING

Dalian Lvshunkou District Traditional Chinese Medicine Hospital

Dalian, China

RECRUITING

Dalian University Affiliated Xinhua Hospital

Dalian, China

RECRUITING

Affiliated Hospital of Hebei University

Hebei, China

RECRUITING

The Second Hospital of Hebei Medical University

Hebei, China

RECRUITING

The Second Affiliated Hospital of Henan University of Science and Technology

Henan, China

RECRUITING

The First Affiliated Hospital of Jiamusi University

Jiamusi, China

RECRUITING

Liaocheng People´s Hospital

Liaocheng, China

RECRUITING

Liuzhou Workers´ Hospital

Liuchow, China

RECRUITING

Luoyang Central Hospital

Luoyang, China

RECRUITING

Puyang Oilfield General Hospital

Pujiang, China

RECRUITING

Qilu Hospital of Shandong University

Qingdao, China

RECRUITING

First Hospital of Shanxi Medical University

Shanxi, China

ACTIVE NOT RECRUITING

Second Hospital of Shanxi Medical University

Shanxi, China

RECRUITING

Shanxi Cardiovascular Hospital

Shanxi, China

RECRUITING

The First People's Hospital Of Shenyang

Shenyang, China

RECRUITING

Siping City Central People's Hospital

Siping, China

RECRUITING

Suining Central Hospital

Suining, China

RECRUITING

Weifang People´s Hospiztal

Weifang, China

RECRUITING

Zhongnan Hospital of Wuhan University

Wuhan, China

ACTIVE NOT RECRUITING

Wuxi No.2 People's Hospital

Wuxi, China

RECRUITING

Yantaishan Hospital

Yantai, China

RECRUITING

Zhumadian Central Hospital

Zhumadian, China

RECRUITING

Zibo Municipal Hospital

Zibo, China

RECRUITING

Related Publications (5)

• Wu Y, Wang M, Ren M, Xu W. The effects of educational background on Montreal Cognitive Assessment screening for vascular cognitive impairment, no dementia, caused by ischemic stroke. J Clin Neurosci. 2013 Oct;20(10):1406-10. doi: 10.1016/j.jocn.2012.11.019. Epub 2013 Jul 24.

  PMID: 23891119 BACKGROUND

• Liu L, Li Z, Zhou H, Duan W, Huo X, Xu W, Li S, Nie X, Liu H, Liu J, Sun D, Wei Y, Zhang G, Yuan W, Zheng L, Liu J, Wang D, Miao Z, Wang Y. Chinese Stroke Association guidelines for clinical management of ischaemic cerebrovascular diseases: executive summary and 2023 update. Stroke Vasc Neurol. 2023 Dec 29;8(6):e3. doi: 10.1136/svn-2023-002998.

  PMID: 38158224 BACKGROUND

• Herrschaft H, Nacu A, Likhachev S, Sholomov I, Hoerr R, Schlaefke S. Ginkgo biloba extract EGb 761(R) in dementia with neuropsychiatric features: a randomised, placebo-controlled trial to confirm the efficacy and safety of a daily dose of 240 mg. J Psychiatr Res. 2012 Jun;46(6):716-23. doi: 10.1016/j.jpsychires.2012.03.003. Epub 2012 Mar 27.

  PMID: 22459264 BACKGROUND

• El Husseini N, Katzan IL, Rost NS, Blake ML, Byun E, Pendlebury ST, Aparicio HJ, Marquine MJ, Gottesman RF, Smith EE; American Heart Association Stroke Council; Council on Cardiovascular and Stroke Nursing; Council on Cardiovascular Radiology and Intervention; Council on Hypertension; and Council on Lifestyle and Cardiometabolic Health. Cognitive Impairment After Ischemic and Hemorrhagic Stroke: A Scientific Statement From the American Heart Association/American Stroke Association. Stroke. 2023 Jun;54(6):e272-e291. doi: 10.1161/STR.0000000000000430. Epub 2023 May 1.

  PMID: 37125534 BACKGROUND

• Cui M, You T, Zhao Y, Liu R, Guan Y, Liu J, Liu X, Wang X, Dong Q. Ginkgo biloba extract EGb 761(R) improves cognition and overall condition after ischemic stroke: Results from a pilot randomized trial. Front Pharmacol. 2023 Mar 29;14:1147860. doi: 10.3389/fphar.2023.1147860. eCollection 2023.

  PMID: 37063270 BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction; Ischemic Stroke

Interventions

Standard of Care; Population Groups

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Demography; Population Characteristics

Study Officials

• Petra Klement

  Dr. Willmar Schwabe GmbH & Co. KG

  STUDY DIRECTOR

Central Study Contacts

Clinical Project Manager

CONTACT

+497214005243; anne-katrin.maly@schwabe.de

Senior Medical Advisor, M.D., Ph.D

CONTACT

+4972140059750; marilia.soria@schwabe.de

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2025
• First Posted: October 24, 2025
• Study Start: November 28, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 23, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (30)