Trial | NCT01245530  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    280
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 Started
Jun 30
2008
Primary Completion
Feb 28
2011
Study Completion
Mar 31
2011
Last Update
Jun 13
2011
Estimate

Drug Aricept

Aricept Comparator Intervention: Drug: Aricept 5~10 mg orally every day for 24weeks

  • Other names: Donepezil HCl

Drug INM-176

INM-176: Experimental Intervention: Drug:INM-176 600~1200 mg orally every day for 24weeks

  • Other names: KR-WAP-026

Aricept Active Comparator

Intervention: Drug: Aricept

INM-176 Experimental

Intervention: Drug: INM-176

Criteria 

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
No Results Posted