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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ginkgo biloba extract 50 dropping pills | Drug | Composition: Ginkgo ketone ester, excipient polyethylene glycol 6000. Size: 10mg ginkgolides/pill. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At 12months±14days after randomization. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At 3months±7days and 6months±14days after randomization. |
| Changes from baseline in total cerebral small vessel disease burden |
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Inclusion Criteria:
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.
Exclusion Criteria:
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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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.
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This trial is a double-blind design using simulants to ensure blinding. In order to ensure the unbiased clinical operation, observation, and evaluation of this trial, a centralized randomization system will be used to achieve the allocation of subject random numbers and therapeutic drugs.
The simulants are consistent with the corresponding subject medications in terms of specifications, appearance, packaging, labeling, and marking, and are labeled for clinical trial use.
| Ginkgo biloba extract Ginkgo biloba extract 50 Drops simulant | Drug | 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. |
|
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). |
| 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. | 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. | 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. | 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 | At 3months±7days, 6months±14days and 12months±14days after randomization. |