Effects of Ginkgo Biloba on Blood Biomarkers in Mild Cognitive Impairment

NCT07579689 | Not Yet Recruiting Phase 4

• 1 other identifier: GURI 2026-04-016-001
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Mild Cognitive Impairment; Alzheimer's Disease

Keywords

Mild Cognitive Impairment; Ginexin; Alzheimer's Disease; Ginkgo Biloba Extract

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Drug: Ginkgo Biloba Extract 240 mg

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.

Drug: Placebo

Interventions

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.

Also known as: Ginexin

Ginkgo Biloba 240 mg

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hanyang University: lead
• SK Chemicals: collaborator

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease

Interventions

Ginkgo biloba extract

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Central Study Contacts

Seong-Ho Koh, MD, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 12, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 12, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share