RecruitingPhase 4

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

China400 participantsStarted 2025-11-28

Plain-language 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.

Who can participate

Age range55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

Change in Montreal Cognitive Assessment (MoCA) Total Score

Timeframe: 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

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

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

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

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

Timeframe: 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)

Timeframe: 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)

Timeframe: 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)

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

Trial details

NCT IDNCT07220538

SponsorDr. Willmar Schwabe GmbH & Co. KG

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-12-31

Contact for this trial

Clinical Project Manager

+497214005243 anne-katrin.maly@schwabe.de

View on ClinicalTrials.gov More Ischemic Stroke Hospitalized trials

Plain-language summary

Who can participate

Age range55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.