This is a multi-center, randomized, double-blind, placebo-controlled, Phase IV Trial to evaluate the efficacy and safety of Choline Alfoscerate compared to placebo in Mild Cognitive Impairment Patients with Cerebrovascular Disease
Subject will be randomised in a 1:1 ratio to receive either Choline Alfoscerate or it's placebo. Investigational Product(IP, Choline Alfoscerate or it's placebo) will be administered 3 times a day per oral during the treatment
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
418
Choline Alfoscerate 400mg per oral 3 times a day during the entrie treatment period
Placebo of Choline Alfoscerate 400mg per oral 3 times a day during the entrie treatment period
Asan Medical Center
Seoul, South Korea
The proportion of subjects whose cognitive function is maintained/improved at 48 weeks compared to baseline
Time frame: Baseline to 48 weeks
The proportion of subjects reduced by more than or eual 0 points for modified ADAS-Cog score at 24 weeks compared to baseline
ADAS-Cog: Alzheimer's Disease Assessment Scale-Cognitive Subscale
Time frame: Baseline to 24 weeks
The proportion of subjects reduced by more than 2 points of modified ADAS-Cog score at 24 to 48 weeks compared to baseline
Time frame: Baseline, 24 weeks, 48 weeks
The proportion of subjects reduced by more than 4 points of modified ADAS-Cog score at 24 to 48 compared to baseline
Time frame: Baseline, 24 weeks, 48 weeks
The change of Modified ADAS-Cog score at 24 to 48 weeks compared to baseline
Time frame: Baseline, 24 weeks, 48 weeks
The proportion of subjects increased by more than 0 point of K-MMSE-2 score at 24 and 48 weeks compared to baseline
K-MMSE-2: Korean version Mini-Mental State Exam-2
Time frame: Baseline, 24 weeks, 48 weeks
The change of K-MMSE-2 score at 24 to 48 weeks compared to baseline
Time frame: Baseline, 24 weeks, 48 weeks
The change of Modified K-MoCA score at 24 to 48 weeks compared to baseline
K-MoCA: Korean-Montreal Cognitive Assessment
Time frame: Baseline, 24 weeks, 48 weeks
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The change of CDR-SB score at 48 weeks compared to baseline
CDR-SB: Sum of Boxes of Clinical Dementia Rating
Time frame: Baseline to 48 weeks