An Efficacy and Safety Study of INM-176 for the Treatment of Patients With Alzheimer Type Dementia

Phase 3

Completed

• Conditions: Alzheimer Type Dementia
• Interventions: Drug: Aricept; Drug: INM-176

• Registration Number: NCT01245530
• Lead Sponsor: Whanin Pharmaceutical Company

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.

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2010-11-01
• Study First Submitted QC: 2010-11-18
• Study First Posted: 2010-11-22
• Primary Completion: 2011-02
• Study Completion: 2011-03
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-09
• Last Update Posted: 2011-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 280

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aricept	Aricept	Intervention: Drug: Aricept
INM-176	INM-176	Intervention: Drug: INM-176

Primary Outcome Measures

Name	Time	Method
Change in cognition as assessed by the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) total score	up to 24 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Whanin Pharm.Co.,Ltd.; 🇰🇷 Seoul, Moonjung, Korea, Republic of