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

  • Korea, Republic of
    • 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:

  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 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
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

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

Whanin Pharmaceutical Company

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

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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