Mild Cognitive ImpairmentPhase 4NCT07579689
Effects of Ginkgo Biloba on Blood Biomarkers in Mild Cognitive Impairment
A Phase 4 study testing Ginkgo Biloba Extract 240 mg in people with Mild Cognitive Impairment and Alzheimer's Disease, run by Hanyang University.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Mild Cognitive Impairment, Alzheimer's Disease
- What is being tested?
- Ginkgo Biloba Extract 240 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to 31 Dec 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 20 years or older
- Clinical Dementia Rating (CDR) score of 0.5
- Patients clinically indicated for treatment with Ginkgo biloba extract
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Gingko Biloba on the Blood Biomarkers in Mild Cognitive Impairment Patients With Alzheimer's Disease
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.
Read the 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.
- Conditions
- Mild Cognitive Impairment, Alzheimer's Disease
- Being tested
- Ginkgo Biloba Extract 240 mg, Placebo
- Keywords
- Mild Cognitive Impairment, Ginexin, Alzheimer's Disease, Ginkgo Biloba Extract
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ginkgo Biloba Extract 240 mgDrug
Also called Ginexin
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study startJun 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanyang University
- Sponsor type
- University, hospital or other
- Collaborators
- SK Chemicals
- Responsible party
- Principal investigator, SEONG-HO KOH, Hanyang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07579689
- Sponsor's protocol ID
- GURI 2026-04-016-001
- Other IDs
- U1111-1342-9252
- Status last verified
- Jun 2026
- First submitted
- 5 May 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data to protect the privacy of study participants and comply with institutional data protection policies.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Gingko Biloba on the Blood Biomarkers in Mild Cognitive Impairment Patients With Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT07579689
- Acronym / sponsor ID
- GURI 2026-04-016-001
- Conditions
- Mild Cognitive Impairment, Alzheimer's Disease
- Keywords
- Mild Cognitive Impairment, Ginexin, Alzheimer's Disease, Ginkgo Biloba Extract
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hanyang UniversityUniversity, hospital or other
- Collaborators
- SK Chemicals
- Study start
- Jun 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 12 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Ginkgo Biloba 240 mg | Experimental | Drug: Ginkgo Biloba Extract 240 mgParticipants in the experimental group will receive a 240 mg Ginkgo biloba extract tablet orally once daily for 6 months. |
| Placebo | Sham comparator | Drug: PlaceboParticipants in the placebo group will receive a placebo tablet, identical in appearance to the Ginkgo biloba tablet, orally once daily for 6 months. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 20 years or older
- Clinical Dementia Rating (CDR) score of 0.5
- Patients clinically indicated for treatment with Ginkgo biloba extract
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ginkgo Biloba Extract 240 mgAlso: GinexinThe 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 | Ginkgo Biloba 240 mg |
| PlaceboA placebo tablet identical in appearance to the Ginkgo biloba tablet. Participants take one tablet orally once daily for 6 months. | Drug | Placebo |
Primary outcome
Change from Baseline in Plasma p-tau217 at 6 Months
Time frame: Baseline, 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data to protect the privacy of study participants and comply with institutional data protection policies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ginkgo Biloba Extract 240 mg in people with Mild Cognitive Impairment and Alzheimer's Disease, run by Hanyang University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Seong-Ho Koh, MD, PhD (+82-31-560-2264, 2057069@hyumc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Plasma p-tau217 at 6 Months (time frame: Baseline, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.