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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1342-9252 | Registry Identifier | WHO |
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| Name | Class |
|---|---|
| SK Chemicals | UNKNOWN |
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This study evaluates the effects of Ginkgo biloba on blood biomarkers related to Alzheimer's disease in patients with mild cognitive impairment. Participants will be randomly assigned to receive either Ginkgo biloba or a placebo for 6 months. Changes in blood biomarkers, including p-tau217 and neurofilament light (NfL), as well as cognitive function, will be assessed to determine whether Ginkgo biloba may influence disease-related biological processes.
Ginkgo biloba has been widely used for cognitive impairment and is suggested to exert neuroprotective effects through antioxidant, anti-inflammatory, and anti-amyloid mechanisms. However, its effects on Alzheimer's disease-related blood biomarkers remain unclear. Alzheimer's disease is characterized by amyloid and tau pathology, which can be partially reflected by plasma p-tau217, while neurofilament light (NfL) reflects neuroaxonal injury.
This is a multicenter, randomized, double-blind, placebo-controlled study conducted in patients with mild cognitive impairment due to Alzheimer's disease. Participants will be assigned in a 1:1 ratio to receive either Ginkgo biloba 240 mg or placebo once daily for 6 months.
The study aims to evaluate whether Ginkgo biloba administration affects these blood biomarkers (p-tau217, NfL) and whether changes in biomarkers are associated with cognitive outcomes measured by the Clinical Dementia Rating-Sum of Boxes (CDR-SB). By analyzing these relationships, this research seeks to explore the potential disease-modifying effects of Ginkgo biloba.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ginkgo Biloba 240 mg | Experimental | Participants in the experimental group will receive a 240 mg Ginkgo biloba extract tablet orally once daily for 6 months. |
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| Placebo | Sham Comparator | Participants in the placebo group will receive a placebo tablet, identical in appearance to the Ginkgo biloba tablet, orally once daily for 6 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ginkgo Biloba Extract 240 mg | Drug | The intervention consists of Ginkgo biloba extract administered as a 240 mg film-coated tablet. Participants take one tablet orally once daily for 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Plasma p-tau217 at 6 Months | Plasma p-tau217 levels will be measured using a validated blood assay at baseline and 6 months after treatment. The concentration of p-tau217 will be used as a biomarker of Alzheimer's disease-related pathology, and changes from baseline will be assessed following administration of Ginkgo biloba extract. | Baseline, 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Seong-Ho Koh, MD, PhD | Contact | +82-31-560-2264 | 2057069@hyumc.com |
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There is no plan to share individual participant data to protect the privacy of study participants and comply with institutional data protection policies.
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003704 | Dementia |
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| ID | Term |
|---|---|
| C063170 | Ginkgo biloba extract |
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Participants are randomly assigned in a 1:1 ratio to either the Ginkgo Biloba 240 mg group or the placebo group. Randomization is performed using a computer-generated random sequence of permutations, applied sequentially from the first enrolled subject, with a block randomization method using randomly varying block sizes. Stratification by clinical site is applied to ensure balanced allocation across study sites. The randomization list is generated by an independent individual not otherwise involved in the study
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| Placebo | Drug | A placebo tablet identical in appearance to the Ginkgo biloba tablet. Participants take one tablet orally once daily for 6 months. |
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| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |