Effects of Ginkgo Biloba on Blood Biomarkers in Mild Cognitive Impairment

Phase 4Not Yet RecruitingNCT07579689

Hanyang University120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

120

Conditions

Mild Cognitive Impairment Alzheimer's Disease

Interventions

Ginkgo Biloba Extract 240 mgDRUG

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.

PlaceboDRUG

A placebo tablet identical in appearance to the Ginkgo biloba tablet. Participants take one tablet orally once daily for 6 months.

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: Baseline, 6 months

Central Contacts

Seong-Ho Koh, MD, PhD

CONTACT

+82-31-560-2264 2057069@hyumc.com

Data from ClinicalTrials.gov

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