Status:
COMPLETED
An Efficacy and Safety Study of INM-176 for the Treatment of Patients With Alzheimer Type Dementia
Lead Sponsor:
Whanin Pharmaceutical Company
Conditions:
Alzheimer Type Dementia
Eligibility:
All Genders
50-80 years
Phase:
PHASE3
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...
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 clinic...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT01245530
Start Date
June 1 2008
End Date
March 1 2011
Last Update
June 13 2011
Active Locations (1)
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1
Whanin Pharm.Co.,Ltd.
Seoul, Moonjung, South Korea, 138-200