NCT06495476 · Phase 4 · NOT YET RECRUITING
Study on Ginkgo Biolba Extract Fifty and Mild Cognitive Impairment Associated With CSVD
This trial is testing whether a concentrated Ginkgo biloba extract, taken daily for 12 months, can slow or reduce cognitive decline in people who already have mild cognitive impairment caused by small vessel disease in the brain. Researchers will measure changes in standard cognitive scores at 3, 6, and 12 months. Phase 4 means the drug is already approved in its market — this is a deeper look at a specific use case.
Eligibility criteria
Inclusion Criteria: 1. Age 50-75 years old, with no limitation on sex. 2. Head MRI showed SVD lesions. High white matter signal, Fazekas score ≥2 and meet one of the following requirements: Have ≥2 vascular risk factors (hypertension, hyperlipidemia, diabetes, current smoking); Combined lacunar foci; Combined with a new subcortical lacunar infarction (within 7 days of onset); 3. Mild vascular cognitive impairment (memory and/or other cognitive domain abnormalities lasting for at least 3 months) with a score of 18 ≤MoCA score \< 26. 4. Insufficient cognitive impairment to affect independence of life (mRS≤2). 5. After enrollment, you can live in the local stable for more than two years. 6. Sign the informed consent form. Exclusion Criteria: 1. Known or suspected allergy to the components of the investigational drug or allergic constitution. 2. With other brain diseases: Alzheimer's disease, Lewy body dementia, Parkinson's disease frontotemporal dementia, Crohn's disease, as well as other diseases that can lead to cognitive impairment, such as subdural hematoma, communicating hydrocephalus, brain tumors, drug poisoning, alcoholism, thyroid disease, and vitamin deficiency. 3. Previous diagnosis of genetic/degenerative/inflammatory related small cerebral vascular diseases, such as CADASIL, CARASIL, etc. 4. Concomitant with major depressive disorder (≥24 score in HAMD-17) or other transient organic psychosis (e.g., schizophrenia) that meets DSM-V criteria. 5. Any medication used to treat cognitive impairment in the 4 weeks prior to randomization. 6. Combined with severe neurological impairment, such as convenient hand hemiplegia, aphasia, auditory and visual impairment, the relevant examination or scale evaluation can not be completed. 7. Combined with severe gastrointestinal diseases such as indigestion, gastrointestinal obstruction, gastric and duodenal ulcers that can affect drug absorption, or inability to swallow medication. 8. Liver enzymes (ALT, AST)>2 times the upper limit of normal value, creatinine>1.2 times the upper limit of normal value, and decreased glomerular filtration rate (\<90ml/min). 9. Life expectancy \< 1 year, or other reasons for not being able to complete follow-up. 10. Pregnant or lactating women, or those with fertility plans. 11. Has participated in other clinical trials.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2024-08-28