Effect of Gingko Biloba on the Blood Biomarkers in Mild Cognitive Impairment Patients With Alzheimer's Disease
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 120
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 20 years or older
- •Clinical Dementia Rating (CDR) score of 0.5
- •Patients clinically indicated for treatment with Ginkgo biloba extract
排除标准
- •Current use of cholinesterase inhibitors such as donepezil, rivastigmine, or galantamine.
- •Refusal to provide informed consent.
- •Presence of neurological or psychiatric conditions other than Alzheimer's disease that may affect cognitive function.
- •Known hypersensitivity to Ginkgo biloba extract or any of its components.
- •Pregnant women.
- •Genetic conditions associated with lactose intolerance, including galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
- •Presence of bleeding disorders at screening, or requirement for continuous use of medications that may affect study drug efficacy (e.g., anticoagulants, antiplatelets, thrombolytics, peripheral vasodilators, PGE1 and its derivatives).
- •Any condition that, in the opinion of the investigator or study staff, makes the participant unsuitable for the study or unable to comply with study procedures.
研究组 & 干预措施
Ginkgo Biloba 240 mg
Participants in the experimental group will receive a 240 mg Ginkgo biloba extract tablet orally once daily for 6 months.
干预措施: Ginkgo Biloba Extract 240 mg (Drug)
Placebo
Participants in the placebo group will receive a placebo tablet, identical in appearance to the Ginkgo biloba tablet, orally once daily for 6 months.
干预措施: Placebo (Drug)
研究者
SEONG-HO KOH
Professor
Hanyang University