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.
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.
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.
Parallel
Extract of Ginkgo Biloba Leaves Tablets 240 mg (2 x 40 mg, t.i.d.)
Drug3 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
Standard of care (SoC) Group
Other interventionIndividualized therapy in accordance with treatment guideline from the Chinese Stroke Association
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 \[Wu et al., 2013\].
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 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 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.
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.
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Dr. Willmar Schwabe GmbH & Co. KG
Lead sponsor
Beijing Tiantan Hospital
Collaborator
