Alzheimer Type Dementia Clinical Trial
Official title:
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
| Verified date | June 2011 |
| Source | Whanin Pharmaceutical Company |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Korea: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 280 |
| Est. completion date | March 2011 |
| Est. primary completion date | February 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 50 Years to 80 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Whanin Pharm.Co.,Ltd. | Seoul | Moonjung |
| Lead Sponsor | Collaborator |
|---|---|
| Whanin Pharmaceutical Company |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in cognition as assessed by the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) total score | up to 24 weeks | No | |
| Secondary | Change from baseline to endpoint in Mini-Mental State Examination (MMSE) | up to 24 weeks | No | |
| Secondary | Change from baseline to endpoint in Clinical Dementia Rating | up to 24 weeks | No | |
| Secondary | Change from baseline to endpoint in Global Deterioration Scale(GDS) | up to 24 weeks | No | |
| Secondary | Change from baseline to endpoint in Korean Activity of Living(K-IADL) | up to 24 weeks | No | |
| Secondary | Change from baseline to endpoint in Korean Neuropsychiatric Inventory (NPI) | up to 24 weeks | No |