Ginkgo biloba extract added to usual care for memory and thinking problems after ischemic stroke

Pragmatic Open-label, Parallel-group Clinical Trial on the Effectiveness of Extract of Ginkgo Biloba Leaves Tablets as add-on to Standard of Care in Participants With Cognitive Impairment After an Acute Ischemic Stroke (GiCIIS)

This trial will test whether adding Ginkgo biloba extract tablets to usual post-stroke care improves thinking and memory in people aged 55 and older who had an ischemic stroke.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 400 (estimated)
• Ages: 55 Years and up
• Sex: All
• Sponsor: Dr. Willmar Schwabe GmbH & Co. KG (Industry-sponsored)
• Locations: 30 sites (Anyang and 29 other locations)
• Trial ID: NCT07220538 on ClinicalTrials.gov

What this trial studies

This is a prospective, multicenter, pragmatic, open-label, parallel-group randomized trial conducted at hospitals across China. Adults aged 55 and older who had a non-disabling ischemic stroke 7–14 days before enrollment and who meet MoCA-based cognitive impairment criteria are randomized 1:1. One group receives Extract of Ginkgo Biloba Leaves Tablets (240 mg/day) in addition to standard of care and the other receives standard of care alone, with follow-up lasting 52 weeks. The trial tracks cognitive outcomes and safety events to determine whether the add-on therapy improves post-stroke cognitive function.

Who should consider this trial

Good fit: Ideal candidates are adults aged 55 or older with a non-disabling ischemic stroke confirmed by MRI 7–14 days earlier, NIHSS ≤5 and mRS ≤2 at screening, MoCA scores meeting the trial cutoff for cognitive impairment, and sufficient Chinese language skills.

Not a fit: People with severe disability, major speech or motor impairments preventing testing, severe uncorrected vision or hearing loss, hemorrhagic stroke, recent participation in another drug trial, or who do not meet the MoCA cutoffs are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, adding Ginkgo biloba extract could improve thinking and memory for some people recovering from an ischemic stroke.

How similar studies have performed: Previous trials of Ginkgo biloba for cognitive impairment, including post-stroke settings, have shown mixed or modest results, so the approach has preliminary but not definitive support.

Eligibility criteria

Inclusion Criteria:

1. Male and female participants aged ≥ 55 years who gave their informed consent.
2. 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.
3. 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).
4. Sufficient Chinese language skills to understand and respond to all interview questions, complete questionnaires and undergo neuropsychological testing.

Exclusion Criteria:

1. Participation in another experimental drug trial at the same time or within the past 4 weeks before enrollment.
2. 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.
3. 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).
4. Cardiogenic ischemic stroke, atrial fibrillation, or any other conditions that require the intake of anticoagulants.
5. Conditions that require the administration of thrombolytics at day of Screening or Visit 1.
6. Index acute ischemic stroke with hemorrhagic transformation.
7. Intake of traditional Chinese medicines.
8. 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.
9. Major depression or generalized anxiety disorder.
10. Active malignant disease.
11. Alcohol addiction or substance abuse.
12. Known hypersensitivity to Ginkgo biloba, Ginkgo biloba extract or any ingredient of the drug under trial.
13. 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).
14. Severe comorbidity with life expectancy \< 12 months.

Where this trial is running

Anyang and 29 other locations

• 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 — Liuzhou, 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)

Study contacts

• Study coordinator: Clinical Project Manager

Conditions Ischemic Stroke Hospitalized; Impairment, Cognitive; Acute ischemic stroke; Cognitive Impairment