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

This study has been completed.
Sponsor:
Information provided by:
Whanin Pharmaceutical Company
ClinicalTrials.gov Identifier:
NCT01245530
First received: November 1, 2010
Last updated: June 9, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Alzheimer Type Dementia
Drug: Aricept
Drug: INM-176
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Whanin Pharmaceutical Company:

Primary Outcome Measures:
  • Change in cognition as assessed by the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) total score [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline to endpoint in Mini-Mental State Examination (MMSE) [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to endpoint in Clinical Dementia Rating [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to endpoint in Global Deterioration Scale(GDS) [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to endpoint in Korean Activity of Living(K-IADL) [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to endpoint in Korean Neuropsychiatric Inventory (NPI) [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 280
Study Start Date: June 2008
Study Completion Date: March 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Aricept
Intervention: Drug: Aricept
Drug: Aricept
Aricept Comparator Intervention: Drug: Aricept 5~10 mg orally every day for 24weeks
Other Name: Donepezil HCl
Experimental: INM-176
Intervention: Drug: INM-176
Drug: INM-176
INM-176: Experimental Intervention: Drug:INM-176 600~1200 mg orally every day for 24weeks
Other Name: KR-WAP-026

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.

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01245530

Locations
Korea, Republic of
Whanin Pharm.Co.,Ltd.
Seoul, Moonjung, Korea, Republic of, 138-200
Sponsors and Collaborators
Whanin Pharmaceutical Company
Investigators
Principal Investigator: SangYoon Kim, MD Seoul National University Bundang Hospital
  More Information

No publications provided

Responsible Party: Heesook Nam, Whanin Pharmaceutical Company
ClinicalTrials.gov Identifier: NCT01245530     History of Changes
Other Study ID Numbers: INM-176
Study First Received: November 1, 2010
Last Updated: June 9, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Whanin Pharmaceutical Company:
Alzheimer disease

Additional relevant MeSH terms:
Dementia
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Tauopathies
Neurodegenerative Diseases
Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014