Effects of Ginkgo Biloba on Blood Biomarkers in Mild Cognitive Impairment

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.

Inclusion criteria

• Age 20 years or older
• Clinical Dementia Rating (CDR) score of 0.5
• Patients clinically indicated for treatment with Ginkgo biloba extract

Exclusion criteria

• 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.