Effects of Ginkgo Biloba on Blood Biomarkers in Mild Cognitive Impairment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ginkgo Biloba Extract 240 mg, Placebo.
- Who it may be relevant to
- Registry conditions: Mild Cognitive Impairment, Alzheimer's Disease. Basic parameters: from 20 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Gingko Biloba on the Blood Biomarkers in Mild Cognitive Impairment Patients With Alzheimer's Disease
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.
Detailed description
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.
Interventions
- Drug Ginkgo Biloba Extract 240 mg
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. - Drug Placebo
A placebo tablet identical in appearance to the Ginkgo biloba tablet. Participants take one tablet orally once daily for 6 months.
Primary outcome measures
- Change from Baseline in Plasma p-tau217 at 6 Months [Time frame: Baseline, 6 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07579689 · GURI 2026-04-016-001 · U1111-1342-9252