Mild Cognitive ImpairmentPhase 2/3GRACENCT06495476
Study on Ginkgo Biolba Extract Fifty and Mild Cognitive Impairment Associated With CSVD
A Phase 2/3 study testing Ginkgo biloba extract 50 dropping pills and Ginkgo biloba extract Ginkgo biloba extract 50 Drops simulant in people with Mild Cognitive Impairment, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
This study aimed to explore the efficacy and safety of Ginkgo Biolba Extract fifty in treating mild cognitive impairment associated with cerebral small vessel disease (CSVD). Subjects included based on eligibility criteria were randomized into treatment and control groups. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Ginkgo biloba extract 50 dropping pills and Ginkgo biloba extract Ginkgo biloba extract 50 Drops simulant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 siteChina
- Study dates
- 27 Sep 2024to 30 Oct 2026
- Phase
- Phase 2/3
- 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 50-75 years old, with no limitation on sex.
- Head MRI showed SVD lesions. High white matter signal, Fazekas score ≥2 and meet one of the following requirements:
- Have ≥2 vascular risk factors (hypertension, hyperlipidemia, diabetes, current smoking); Combined lacunar foci; Combined with a new subcortical lacunar infarction (within 7 days of onset);
- Mild vascular cognitive impairment (memory and/or other cognitive domain abnormalities lasting for at least 3 months) with a score of 18 ≤MoCA score < 26.
- Insufficient cognitive impairment to affect independence of life (mRS≤2).
- After enrollment, you can live in the local stable for more than two years.
- Sign the informed consent form.
Who cannot join
- Known or suspected allergy to the components of the investigational drug or allergic constitution.
- With other brain diseases: Alzheimer's disease, Lewy body dementia, Parkinson's disease frontotemporal dementia, Crohn's disease, as well as other diseases that can lead to cognitive impairment, such as subdural hematoma, communicating hydrocephalus, brain tumors, drug poisoning, alcoholism, thyroid disease, and vitamin deficiency.
- Previous diagnosis of genetic/degenerative/inflammatory related small cerebral vascular diseases, such as CADASIL, CARASIL, etc.
- Concomitant with major depressive disorder (≥24 score in HAMD-17) or other transient organic psychosis (e.g., schizophrenia) that meets DSM-V criteria.
- Any medication used to treat cognitive impairment in the 4 weeks prior to randomization.
- Combined with severe neurological impairment, such as convenient hand hemiplegia, aphasia, auditory and visual impairment, the relevant examination or scale evaluation can not be completed.
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- Combined with severe gastrointestinal diseases such as indigestion, gastrointestinal obstruction, gastric and duodenal ulcers that can affect drug absorption, or inability to swallow medication.
- Liver enzymes (ALT, AST)>2 times the upper limit of normal value, creatinine>1.2 times the upper limit of normal value, and decreased glomerular filtration rate (<60ml/min).
- Life expectancy < 1 year, or other reasons for not being able to complete follow-up.
- Pregnant or lactating women, or those with fertility plans.
- Has participated in other clinical trials.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070
About this study
Official title: Study on Ginkgo Biolba Extract Fifty in the Treatment of Mild Cognitive Impairment Associated With Cerebral Small Vessel Disease
This study aimed to explore the efficacy and safety of Ginkgo Biolba Extract fifty in treating mild cognitive impairment associated with cerebral small vessel disease (CSVD). Subjects included based on eligibility criteria were randomized into treatment and control groups. Patients will receive the drug or placebo for 12 months. Patients were followed at baseline and at 3 months, 6 months, and 12 months after randomization. The primary outcome was the difference from baseline in the Montreal Cognitive Assessmen (MoCA) score at 12 months after randomization.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Ginkgo biloba extract 50 dropping pills, Ginkgo biloba extract Ginkgo biloba extract 50 Drops simulant
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ginkgo biloba extract 50 dropping pillsDrug
Composition: Ginkgo ketone ester, excipient polyethylene glycol 6000. Size: 10mg ginkgolides/pill.
Ginkgo biloba extract Ginkgo biloba extract 50 Drops simulantDrug
Composition: The main ingredient is polyethylene glycol 6000 + caramel pigment, placebo and ginkgolide drops are basically the same in color, odor and appearance.
Size: 10 mg analog ingredient/pill.
| Study group | Role | What they receive |
|---|---|---|
| Ginkgo biloba extract 50 dropping pills treatment group | Active comparator | Ginkgo biloba extract 50 dropping pills, oral administration, 8 dropping pills /time, 3 times/day Receives: Drug: Ginkgo biloba extract 50 dropping pills |
| Ginkgo biloba extract 50 dropping pills Simulant treatment group | Placebo comparator | Ginkgo biloba extract 50 dropping pills simulant, oral administration, 8 dropping pills /time, 3 times/day Receives: Drug: Ginkgo biloba extract Ginkgo biloba extract 50 Drops simulant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Montreal Cognitive Assessment Scale
Montreal Cognitive Assessment Scale (Beijing Edition) scores from 0 to 30. A higher score indicates better cognitive function.
Measured: At 12months±14days after randomization.
Secondary outcomes (6)
Change from baseline in Montreal Cognitive Assessment Scale
Montreal Cognitive Assessment Scale (Beijing Edition) scores from 0 to 30. Higher score indicates better cognitive function.
Measured: At 3months±7days and 6months±14days after randomization.
Changes from baseline in total cerebral small vessel disease burden
The severity of periventricular WMH (PV-WMH) and the deep-WMH were rated by Fazekas rating scale. The numbers of lacune and cerebral microbleed (CMB) will be collected. Perivascular spaces (PVS) in the basal ganglia was rated with the semi-quantitative rating scale developed by the Edinburg group. Total CSVD burden was the sum of points awarded for the presence or absence of four MRI markers: one point was awarded if lacunes were present, one point was awarded if CMBs were present, one point was awarded if there were moderate to severe PVS (>10) in the basal ganglia, and one point was awarded for either confluent deep WMH (Fazekas scale 2 or 3) or irregular PV-WMH extending into the deep white matter (Fazekas score 3).
Measured: At 12months±14days after randomization.
Changes from baseline in Mini-mental State Examination score
Mini-mental State Examination (MMSE) scores from 0 to 30. A higher score indicates better cognitive function.
Measured: At 3months±7days, 6months±14days and 12months±14days after randomization.
Change from baseline in the Ability Daily Living score
Ability Daily Living (ADL) scores from 14 to 56. A higher score indicates a worse ability of daily living.
Measured: At 3months±7days, 6months±14days and 12months±14days after randomization.
Change from baseline in Social functioning questionnaire
Social functioning questionnaire (FAQ) scores from 0 to 30. A higher score indicates a worse capacity of action.
Measured: At 3months±7days, 6months±14days and 12months±14days after randomization.
Change from baseline in biomarkers
Biomarkers including hs-CRP, IL-6, TNF-α, Hcy, D-dimer, Fib
Measured: At 3months±7days, 6months±14days and 12months±14days after randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start27 Sep 2024
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2026 (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.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This trial was a randomized, multicenter, double-blind, placebo-controlled parallel trial. Participants were randomly assigned according to the ratio of the experimental group: control group =1:1.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yilong Wang, Beijing Tiantan Hospital
- Investigators
- Yuesong Pan, Study director, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06495476
- Sponsor's protocol ID
- KY2024-090-01
- Acronym
- GRACE
- Status last verified
- Oct 2026
- First submitted
- 16 Jun 2024
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Ginkgo Biolba Extract Fifty in the Treatment of Mild Cognitive Impairment Associated With Cerebral Small Vessel Disease
- ClinicalTrials.gov ID
- NCT06495476
- Acronym / sponsor ID
- GRACE / KY2024-090-01
- Conditions
- Mild Cognitive Impairment
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 27 Sep 2024 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 10 Jul 2024 (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 aimed to explore the efficacy and safety of Ginkgo Biolba Extract fifty in treating mild cognitive impairment associated with cerebral small vessel disease (CSVD). Subjects included based on eligibility criteria were randomized into treatment and control groups. Patients will receive the drug or placebo for 12 months. Patients were followed at baseline and at 3 months, 6 months, and 12 months after randomization. The primary outcome was the difference from baseline in the Montreal Cognitive Assessmen (MoCA) score at 12 months after randomization.
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
- This trial was a randomized, multicenter, double-blind, placebo-controlled parallel trial. Participants were randomly assigned according to the ratio of the experimental group: control group =1:1.
| Arm | Type | Receives |
|---|---|---|
| Ginkgo biloba extract 50 dropping pills treatment group | Active comparator | Drug: Ginkgo biloba extract 50 dropping pillsGinkgo biloba extract 50 dropping pills, oral administration, 8 dropping pills /time, 3 times/day |
| Ginkgo biloba extract 50 dropping pills Simulant treatment group | Placebo comparator | Drug: Ginkgo biloba extract Ginkgo biloba extract 50 Drops simulantGinkgo biloba extract 50 dropping pills simulant, oral administration, 8 dropping pills /time, 3 times/day |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 50-75 years old, with no limitation on sex.
- Head MRI showed SVD lesions. High white matter signal, Fazekas score ≥2 and meet one of the following requirements:
- Have ≥2 vascular risk factors (hypertension, hyperlipidemia, diabetes, current smoking); Combined lacunar foci; Combined with a new subcortical lacunar infarction (within 7 days of onset);
- Mild vascular cognitive impairment (memory and/or other cognitive domain abnormalities lasting for at least 3 months) with a score of 18 ≤MoCA score < 26.
- Insufficient cognitive impairment to affect independence of life (mRS≤2).
Key exclusion criteria (11 listed)
- Known or suspected allergy to the components of the investigational drug or allergic constitution.
- With other brain diseases: Alzheimer's disease, Lewy body dementia, Parkinson's disease frontotemporal dementia, Crohn's disease, as well as other diseases that can lead to cognitive impairment, such as subdural hematoma, communicating hydrocephalus, brain tumors, drug poisoning, alcoholism, thyroid disease, and vitamin deficiency.
- Previous diagnosis of genetic/degenerative/inflammatory related small cerebral vascular diseases, such as CADASIL, CARASIL, etc.
- Concomitant with major depressive disorder (≥24 score in HAMD-17) or other transient organic psychosis (e.g., schizophrenia) that meets DSM-V criteria.
- Any medication used to treat cognitive impairment in the 4 weeks prior to randomization.
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 50 dropping pillsComposition: Ginkgo ketone ester, excipient polyethylene glycol 6000. Size: 10mg ginkgolides/pill. | Drug | Ginkgo biloba extract 50 dropping pills treatment group |
| Ginkgo biloba extract Ginkgo biloba extract 50 Drops simulantComposition: The main ingredient is polyethylene glycol 6000 + caramel pigment, placebo and ginkgolide drops are basically the same in color, odor and appearance. Size: 10 mg analog ingredient/pill. | Drug | Ginkgo biloba extract 50 dropping pills Simulant treatment group |
Primary outcome
Change from baseline in Montreal Cognitive Assessment Scale
Time frame: At 12months±14days after randomization.
Montreal Cognitive Assessment Scale (Beijing Edition) scores from 0 to 30. A higher score indicates better cognitive function.
6 secondary outcomes
Change from baseline in Montreal Cognitive Assessment Scale
Time frame: At 3months±7days and 6months±14days after randomization.
Changes from baseline in total cerebral small vessel disease burden
Time frame: At 12months±14days after randomization.
Changes from baseline in Mini-mental State Examination score
Time frame: At 3months±7days, 6months±14days and 12months±14days after randomization.
Change from baseline in the Ability Daily Living score
Time frame: At 3months±7days, 6months±14days and 12months±14days after randomization.
Change from baseline in Social functioning questionnaire
Time frame: At 3months±7days, 6months±14days and 12months±14days after randomization.
Change from baseline in biomarkers
Time frame: At 3months±7days, 6months±14days and 12months±14days after randomization.
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 8 Oct 2026.
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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. This study is not recruiting at the moment.
Yuesong Pan study director
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ginkgo biloba extract 50 dropping pills and Ginkgo biloba extract Ginkgo biloba extract 50 Drops simulant in people with Mild Cognitive Impairment, run by Beijing Tiantan Hospital at 1 site in China.
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 7 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Montreal Cognitive Assessment Scale (time frame: At 12months±14days after randomization.). 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 8 Oct 2026.