An Efficacy and Safety Study of INM-176 for the Treatment of 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.

Inclusion criteria

• Male or female, age range : 50 ~ 80 years old
• Informed consent signed and dated by patient or legal representative
• Subjects diagnosed with Alzheimer's disease according to DSM-IV criteria
• Subjects diagnosed with probable Alzheimer's disease according to the National Institute of Neurological and Communicative Disorders and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
• MMSE score 10 to 26
• CDR(Clinical Dementia Rating) score 1~2 or GDS(Global Deterioration Scale) 3~5 stage
• Subjects who didn't take any medication for AchEI (donepezil, memantine, galantamin, etc) before treating or can stop medication at least 4 weeks more prior to screening visit
• Subjects menopause women or her/his spouse consent with contraception during the study period and 90 days after end of study

Exclusion criteria

• Subjects with psychiatric disorders other than Alzheimer's disease, such as schizophrenia, depression, bipolar disorder, etc
• Subjects diagnosed or accompanied with Dementia due to other Neurodegenerative disorders (AIDS, syphilis, creutzfeldt-jacob disease, Picks Disease, Huntingtons Disease, Parkinsons disease related dementia)
• Subjects diagnosed with vascular dementia
• Subjects diagnosed with stroke within last 3 months prior to screening visit
• Subjects who have medical history of significant hepatic disease in screening visit (2 ULN≤ALT, AST)
• Subjects who have medical history of significant renal disease in screening visit (1.5mg/dl≤Serum creatinine)
• Subjects who have difficult with regulating blood glucose level with anti-diabetes drug (8.0%<HbA1c)
• Subjects who have medical history of myocardial infarction or arrhythmia
• Subjects who take warfarin with Atrial fibrillation
• Pregnant or nursing women
• Subjects who p0articipated in other clinical trail within last 3 months
• Subjects who have hypersensitivity to AchEl (acetylcholinesterase inhibitor)
• Subjects who have unstable clinical laboratory result in screening visit
• Subjects doubted the pulmonary disease on the chest X-ray in screening visit
• Subjects considered unsuitable to participate in clinical trail by investigator