The purpose of this study is to evaluate the efficacy and safety of two fixed dose (1200mg/day, 1600mg/day) of INM-176 (a drug of treating dementia) comparing with donepezil for treatment for patients with Alzheimer type dementia.
Probable Alzheimer type dementia compare INM-176 1200\~1600mg/day with Donepezil 5\~10mg/day of safety and efficacy to randomization, multicenter, double-blind, double-dummy, parallel Phase III clinical study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
280
Whanin Pharm.Co.,Ltd.
Seoul, Moonjung, South Korea
Change in cognition as assessed by the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) total score
Time frame: up to 24 weeks
Change from baseline to endpoint in Mini-Mental State Examination (MMSE)
Time frame: up to 24 weeks
Change from baseline to endpoint in Clinical Dementia Rating
Time frame: up to 24 weeks
Change from baseline to endpoint in Global Deterioration Scale(GDS)
Time frame: up to 24 weeks
Change from baseline to endpoint in Korean Activity of Living(K-IADL)
Time frame: up to 24 weeks
Change from baseline to endpoint in Korean Neuropsychiatric Inventory (NPI)
Time frame: up to 24 weeks
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