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

Whanin Pharmaceutical Company1 site in 1 country280 target enrollmentJune 2008

ConditionsAlzheimer Type Dementia

InterventionsAricept INM-176

DrugsAricept INM-176

Overview

Phase: Phase 3
Intervention: Aricept
Conditions: Alzheimer Type Dementia
Sponsor: Whanin Pharmaceutical Company
Enrollment: 280
Locations: 1
Primary Endpoint: Change in cognition as assessed by the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) total score
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

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.

Registry

clinicaltrials.gov

Start Date

June 2008

End Date

March 2011

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Whanin Pharmaceutical Company

Eligibility 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

Arms & Interventions

Aricept

Intervention: Drug: Aricept

Intervention: Aricept

INM-176

Intervention: Drug: INM-176

Intervention: INM-176

Outcomes

Primary Outcomes

Change in cognition as assessed by the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) total score

Time Frame: up to 24 weeks

Secondary Outcomes

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)