Alzheimer Type Dementia
Conditions
Keywords
Alzheimer disease
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.
Interventions
DRUGAricept
Aricept Comparator Intervention: Drug: Aricept 5\ 10 mg orally every day for 24weeks
DRUGINM-176
INM-176: Experimental Intervention: Drug:INM-176 600\ 1200 mg orally every day for 24weeks
Sponsors
Whanin Pharmaceutical Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
South Korea
Outcome results
None listed