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

Sponsor
Whanin Pharmaceutical Company (Industry)
Overall Status
Completed
CT.gov ID
NCT01245530
Collaborator
(none)
280
Enrollment
1
Location
2
Arms
33
Duration (Months)
8.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

Probable Alzheimer type dementia compare INM-176 12001600mg/day with Donepezil 510mg/day of safety and efficacy to randomization, multicenter, double-blind, double-dummy, parallel Phase III clinical study.

Study Design

Study Type:
Interventional
Actual Enrollment :
280 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, 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
Study Start Date :
Jun 1, 2008
Actual Primary Completion Date :
Feb 1, 2011
Actual Study Completion Date :
Mar 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Aricept

Intervention: Drug: Aricept

Drug: Aricept
Aricept Comparator Intervention: Drug: Aricept 5~10 mg orally every day for 24weeks
Other Names:
  • 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 Names:
  • KR-WAP-026

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Change from baseline to endpoint in Mini-Mental State Examination (MMSE) [up to 24 weeks]

    2. Change from baseline to endpoint in Clinical Dementia Rating [up to 24 weeks]

    3. Change from baseline to endpoint in Global Deterioration Scale(GDS) [up to 24 weeks]

    4. Change from baseline to endpoint in Korean Activity of Living(K-IADL) [up to 24 weeks]

    5. Change from baseline to endpoint in Korean Neuropsychiatric Inventory (NPI) [up to 24 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts 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 12 or GDS(Global Deterioration Scale) 35 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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01245530
    Other Study ID Numbers:
    • INM-176
    First Posted:
    Nov 22, 2010
    Last Update Posted:
    Jun 13, 2011
    Last Verified:
    Jun 1, 2011
    Keywords provided by , ,
    Alzheimer disease
    Additional relevant MeSH terms:
    Dementia
    Alzheimer Disease
    Donepezil

    Study Results

    No Results Posted as of Jun 13, 2011