Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| ChiCTR2500107051 | Registry Identifier | China Clinical Trial Registry |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Beijing Tiantan Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Participants will:
This is a prospective, multicenter, pragmatic, open-label, parallel-group, randomized clinical trial to investigate the effectiveness and safety of Extract of Ginkgo Biloba Leaves Tablets as add-on to standard of care in participants with cognitive impairment after an acute ischemic stroke (AIS). The trial will be conducted at hospitals across China. Participants that had had a non-disabling overt AIS (i. e., NIHSS (National Institutes of Health Stroke Scale) ≤ 5, mRS (Modified Rankin Scale) ≤ 2 at the day of screening), confirmed by MRI (magnetic resonance imaging), 7 to 14 days before screening will be randomized 1:1 to Extract of Ginkgo Biloba Leaves Tablets (240 mg total dose per day, (3 x (2 x 40 mg)) in addition to standard of care or standard of care alone. The total duration of the trial will be 52 weeks per trial participant.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Standard of Care | Sham Comparator | Standard of Care (SoC) Group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and Nature of Adverse Events, Adverse Drug Reactions, and Serious Adverse Events [Safety Assessment] | Safety will be assessed by documenting the frequency and nature of adverse events (AEs), adverse drug reactions (ADRs), and serious adverse events (SAEs) throughout the entire trial period. Investigators will record the number of participants experiencing each type of event, including details on severity, relationship to study treatment, and outcome. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Project Manager | Contact | +497214009583 | sandra.christochowitz@schwabe.de | |
| Senior Medical Advisor, M.D., Ph.D | Contact | +4972140059750 | marilia.soria@schwabe.de |
| Name | Affiliation | Role |
|---|---|---|
| Petra Klement | Dr. Willmar Schwabe GmbH & Co. KG | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The People's Hospital of Anyang City | Recruiting | Anyang | China | |||
| Baotou Central Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23891119 | Background | 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. | |
| 38158224 | 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. |
Not provided
Not provided
Due to ethical reasons and in terms of data protection law, raw data cannot be shared
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Standard of care (SoC) Group | Other | Individualized therapy in accordance with treatment guideline from the Chinese Stroke Association |
|
| 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:
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
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 |
| up to 52 weeks |
| Recruiting |
| Baotou |
| China |
| Tiantan Hospital | Recruiting | Beijing | China |
| Beipiao Central Hospital | Recruiting | Beipiao | China |
| Benxi Central Hospital | Recruiting | Benxi | China |
| The First People's Hospital of Chenzhou | Recruiting | Chenzhou | China |
| Affiliated Hospital of Chifeng University | Active, not recruiting | Chifeng | China |
| Affiliated Zhongshan Hospital of Dalian University | Recruiting | Dalian | China |
| Central Hospital of Dalian University of Technology (Dalian Municipal Central Hospital) | Recruiting | Dalian | China |
| Dalian Lvshunkou District Traditional Chinese Medicine Hospital | Recruiting | Dalian | China |
| Dalian University Affiliated Xinhua Hospital | Recruiting | Dalian | China |
| Hainan General Hospital | Recruiting | Hainan | China |
| The 2nd Affiliated Hospital of Harbin Medical University | Recruiting | Harbin | China |
| Affiliated Hospital of Hebei University | Recruiting | Hebei | China |
| The Second Hospital of Hebei Medical University | Recruiting | Hebei | China |
| The Second Affiliated Hospital of Henan University of Science and Technology | Recruiting | Henan | China |
| Hengshui People's Hospital (Harrison International Peace Hospital) | Recruiting | Hengshui | China |
| Huizhou First Hospital | Recruiting | Huizhou | China |
| The First Affiliated Hospital of Jiamusi University | Recruiting | Jiamusi | China |
| China-Japan Union Hospital of Jilin University | Recruiting | Jilin City | China |
| Jiujiang No.1 People's Hospital | Recruiting | Jiujiang | China |
| Liaocheng People´s Hospital | Recruiting | Liaocheng | China |
| Liuzhou Workers´ Hospital | Recruiting | Liuzhou | China |
| Luoyang Central Hospital | Recruiting | Luoyang | China |
| Nanning First People's Hospital | Recruiting | Nanning | China |
| Puyang Oilfield General Hospital | Recruiting | Pujiang | China |
| Qilu Hospital of Shandong University | Recruiting | Qingdao | China |
| First Hospital of Shanxi Medical University | Active, not recruiting | Shanxi | China |
| Second Hospital of Shanxi Medical University | Recruiting | Shanxi | China |
| Shanxi Cardiovascular Hospital | Recruiting | Shanxi | China |
| The First People's Hospital Of Shenyang | Recruiting | Shenyang | China |
| The People's Hospital of Liaoning Province | Recruiting | Shenyang | China |
| Siping City Central People's Hospital | Recruiting | Siping | China |
| Suining Central Hospital | Recruiting | Suining | China |
| Weifang People´s Hospiztal | Recruiting | Weifang | China |
| Zhongnan Hospital of Wuhan University | Active, not recruiting | Wuhan | China |
| Wuxi No.2 People's Hospital | Recruiting | Wuxi | China |
| Yantaishan Hospital | Recruiting | Yantai | China |
| Zhumadian Central Hospital | Recruiting | Zhumadian | China |
| Zibo Municipal Hospital | Recruiting | Zibo | China |
| 22459264 | 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. |
| 37125534 | 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. |
| 37063270 | 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. |
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| D044382 | Population Groups |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D003710 | Demography |
| D011154 | Population Characteristics |
Not provided
Not provided