The purpose of this clinical trial is to exploratively evaluate the efficacy and safety of NVP -NK4146 in improving mild cognitive impairment (MCI) in patients with due to Alzheimer's disease (AD) compared to placebo
36-week, single-center, randomized, double-blind, parallel-design, placebo-controlled trial
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
BID for 36 weeks orally
BID for 36 weeks orally
amyloid PET scan
Changes in brain amyloid measured by amyloid PET scan from baseline to 36 weeks
Time frame: baseline and 36 weeks
ADAS-Cog(Alzheimer's Disease Assessment Scale-Cognitive Subscale)13
Changes in ADAS-Cog 13 total score, memory score, and subscales from baseline to 36 weeks
Time frame: baseline and 36 weeks
CDR-SB(Clinical Dementia Rating-Sum of Boxes)
Changes in CDR-SB(Clinical Dementia Rating-Sum of Boxes) and CDR total score from baseline to 36 weeks
Time frame: baseline and 36 weeks
GDS (Global Deterioration Scale)
Change in GDS total score from baseline to 36 weeks
Time frame: baseline and 36 weeks
K-MMSE (the Korean Mini-Mental State Examination)
Change in K-MMSE total score from baseline to 36 weeks
Time frame: baseline and 36 weeks
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