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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Alzheimer Type Dementia

Intervention / Treatment
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* Drug: Aricept
* Drug: INM-176


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Aricept<br>Intervention: Drug: Aricept | Drug: Aricept<br>* Aricept Comparator Intervention: Drug: Aricept 5 10 mg orally every day for 24weeks<br>* Other names: Donepezil HCl;|
| Experimental: INM-176<br>Intervention: Drug: INM-176 | Drug: INM-176<br>* INM-176: Experimental Intervention: Drug:INM-176 600 1200 mg orally every day for 24weeks<br>* Other names: KR-WAP-026;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cognition as assessed by the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) total score |  | up to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to endpoint in Mini-Mental State Examination (MMSE) |  | up to 24 weeks | 
| Change from baseline to endpoint in Clinical Dementia Rating |  | up to 24 weeks | 
| Change from baseline to endpoint in Global Deterioration Scale(GDS) |  | up to 24 weeks | 
| Change from baseline to endpoint in Korean Activity of Living(K-IADL) |  | up to 24 weeks | 
| Change from baseline to endpoint in Korean Neuropsychiatric Inventory (NPI) |  | up to 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alzheimer disease