An Efficacy and Safety Study of INM-176 for the Treatment of Patients With Alzheimer Type Dementia

• Change from baseline to endpoint in Mini-Mental State Examination (MMSE) [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
• Change from baseline to endpoint in Clinical Dementia Rating [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
• Change from baseline to endpoint in Global Deterioration Scale(GDS) [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
• Change from baseline to endpoint in Korean Activity of Living(K-IADL) [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
• Change from baseline to endpoint in Korean Neuropsychiatric Inventory (NPI) [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]

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.

• Drug: Aricept
  Aricept Comparator Intervention: Drug: Aricept 5~10 mg orally every day for 24weeks
  Other Name: Donepezil HCl
• Drug: INM-176
  INM-176: Experimental Intervention: Drug:INM-176 600~1200 mg orally every day for 24weeks
  Other Name: KR-WAP-026

• Active Comparator: Aricept
  Intervention: Drug: Aricept
  Intervention: Drug: Aricept
• Experimental: INM-176
  Intervention: Drug: INM-176
  Intervention: Drug: INM-176

Inclusion Criteria:

1. Male or female, age range : 50 ~ 80 years old
2. Informed consent signed and dated by patient or legal representative
3. Subjects diagnosed with Alzheimer's disease according to DSM-IV criteria
4. 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
5. MMSE score 10 to 26
6. CDR(Clinical Dementia Rating) score 1~2 or GDS(Global Deterioration Scale) 3~5 stage
7. 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
8. Subjects menopause women or her/his spouse consent with contraception during the study period and 90 days after end of study

Exclusion Criteria:

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