- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01245530
An Efficacy and Safety Study of INM-176 for the Treatment of Patients With Alzheimer Type Dementia
June 9, 2011 updated by: Whanin Pharmaceutical Company
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
280
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Moonjung
-
Seoul, Moonjung, Korea, Republic of, 138-200
- Whanin Pharm.Co.,Ltd.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female, age range : 50 ~ 80 years old
- Informed consent signed and dated by patient or legal representative
- Subjects diagnosed with Alzheimer's disease according to DSM-IV criteria
- 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
- MMSE score 10 to 26
- CDR(Clinical Dementia Rating) score 1~2 or GDS(Global Deterioration Scale) 3~5 stage
- 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
- Subjects menopause women or her/his spouse consent with contraception during the study period and 90 days after end of study
Exclusion Criteria:
- Subjects with psychiatric disorders other than Alzheimer's disease, such as schizophrenia, depression, bipolar disorder, etc
- Subjects diagnosed or accompanied with Dementia due to other Neurodegenerative disorders (AIDS, syphilis, creutzfeldt-jacob disease, Picks Disease, Huntingtons Disease, Parkinsons disease related dementia)
- Subjects diagnosed with vascular dementia
- Subjects diagnosed with stroke within last 3 months prior to screening visit
- Subjects who have medical history of significant hepatic disease in screening visit (2 ULN≤ALT, AST)
- Subjects who have medical history of significant renal disease in screening visit (1.5mg/dl≤Serum creatinine)
- Subjects who have difficult with regulating blood glucose level with anti-diabetes drug (8.0%<HbA1c)
- Subjects who have medical history of myocardial infarction or arrhythmia
- Subjects who take warfarin with Atrial fibrillation
- Pregnant or nursing women
- Subjects who p0articipated in other clinical trail within last 3 months
- Subjects who have hypersensitivity to AchEl (acetylcholinesterase inhibitor)
- Subjects who have unstable clinical laboratory result in screening visit
- Subjects doubted the pulmonary disease on the chest X-ray in screening visit
- Subjects considered unsuitable to participate in clinical trail by investigator
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Aricept
Intervention: Drug: Aricept
|
Aricept Comparator Intervention: Drug: Aricept 5~10 mg orally every day for 24weeks
Other Names:
|
Experimental: INM-176
Intervention: Drug: INM-176
|
INM-176: Experimental Intervention: Drug:INM-176 600~1200 mg orally every day for 24weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in cognition as assessed by the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) total score
Time Frame: up to 24 weeks
|
up to 24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline to endpoint in Mini-Mental State Examination (MMSE)
Time Frame: up to 24 weeks
|
up to 24 weeks
|
Change from baseline to endpoint in Clinical Dementia Rating
Time Frame: up to 24 weeks
|
up to 24 weeks
|
Change from baseline to endpoint in Global Deterioration Scale(GDS)
Time Frame: up to 24 weeks
|
up to 24 weeks
|
Change from baseline to endpoint in Korean Activity of Living(K-IADL)
Time Frame: up to 24 weeks
|
up to 24 weeks
|
Change from baseline to endpoint in Korean Neuropsychiatric Inventory (NPI)
Time Frame: up to 24 weeks
|
up to 24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: SangYoon Kim, MD, Seoul National University Bundang Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2008
Primary Completion (Actual)
February 1, 2011
Study Completion (Actual)
March 1, 2011
Study Registration Dates
First Submitted
November 1, 2010
First Submitted That Met QC Criteria
November 18, 2010
First Posted (Estimate)
November 22, 2010
Study Record Updates
Last Update Posted (Estimate)
June 13, 2011
Last Update Submitted That Met QC Criteria
June 9, 2011
Last Verified
June 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurocognitive Disorders
- Neurodegenerative Diseases
- Tauopathies
- Dementia
- Alzheimer Disease
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Cholinergic Agents
- Enzyme Inhibitors
- Nootropic Agents
- Cholinesterase Inhibitors
- Donepezil
Other Study ID Numbers
- INM-176
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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