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 patients with degenerative mild cognitive impairment.
Subjects will be randomised in a 1:1 ratio to receive either Choline Alfoscerate or its placebo. Investigational Products(IP, Choline Alfoscerate or its placebo) will be administered 3 times a day per oral during the treatment period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
418
Choline Alfoscerate 400mg per oral 3 times a day during the entire treatment period.
Placebo of Choline Alfoscerate 400mg per oral 3 times a day during the entire treatment period.
Asan Medical Center Institutional Review Board
Seoul, South Korea
The proportion of subjects whose cognitive function is maintained/improved at 48 weeks compared to baseline
Definition of maintained/improved of cognitive function: decreased by more than or equal to 0 point of modified ADAS-Cog score
Time frame: Baseline to 48 weeks
The proportion of subjects reduced by more than or equal to 0 points for modified ADAS-Cog score at 24 weeks compared to baseline
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 weeks 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
The Modified ADAS-Cog 13 scale has a total of 85 points, and the higher the score, the higher the severity.
Time frame: Baseline, 24 weeks, 48 weeks
The proportion of subjects increased by more than or equal to 0 point of K-MMSE-2 score at 24 and 48 weeks compared to baseline
Time frame: Baseline, 24 weeks, 48 weeks
The change of K-MMSE-2 score at 24 to 48 weeks compared to baseline
K-MMSE-2 scale has a total of 30 points, and the lower the score, the higher the severity.
Time frame: Baseline, 24 weeks, 48 weeks
The change of CDR-SB score at 48 weeks compared to baseline
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
CDR-SB calculates the CDR score as Sum of Boxes, in which case, the score in the six areas obtained by the evaluation is added as it is, and the range of the total score is 0 to 30, and the higher the score, the more severe the degree of dementia.
Time frame: Baseline to 48 weeks