Study on Ginkgo Biolba Extract Fifty and Mild Cognitive Impairment Associated With CSVD
NCT Number: NCT06495476
Acronym: GRACE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Mild Cognitive Impairment
Interventions: DRUG: Ginkgo biloba extract 50 dropping pills|DRUG: Ginkgo biloba extract Ginkgo biloba extract 50 Drops simulant
Sponsor: Beijing Tiantan Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 144
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2026-06-30

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. 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.

Primary Outcome Measures: 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.
Secondary Outcome Measures: 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, 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.