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

NCT ID: NCT01245530

Last Updated: 2011-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 280 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2011-03-31

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.

Conditions

Alzheimer Type Dementia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Aricept

Intervention: Drug: Aricept

Group Type: ACTIVE_COMPARATOR

Aricept

Intervention Type: DRUG

Aricept Comparator Intervention: Drug: Aricept 5\~10 mg orally every day for 24weeks

INM-176

Intervention: Drug: INM-176

Group Type: EXPERIMENTAL

INM-176

Intervention Type: DRUG

INM-176: Experimental Intervention: Drug:INM-176 600\~1200 mg orally every day for 24weeks

Interventions

Aricept

Aricept Comparator Intervention: Drug: Aricept 5\~10 mg orally every day for 24weeks

Intervention Type: DRUG

INM-176

INM-176: Experimental Intervention: Drug:INM-176 600\~1200 mg orally every day for 24weeks

Intervention Type: DRUG

Other Intervention Names

Donepezil HCl; KR-WAP-026

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Whanin Pharmaceutical Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Whanin Pharmaceutical Company

Principal Investigators

SangYoon Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

Whanin Pharm.Co.,Ltd.

Seoul, Moonjung, South Korea

Countries

South Korea

Other Identifiers

INM-176

Identifier Type: -

Identifier Source: org_study_id