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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
144
Composition: Ginkgo ketone ester, excipient polyethylene glycol 6000. Size: 10mg ginkgolides/pill.
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.
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.
Time frame: At 12months±14days after randomization.
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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: 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
Time frame: At 3months±7days, 6months±14days and 12months±14days after randomization.