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

Primary Purpose

Alzheimer Type Dementia

Status

Completed

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Aricept

INM-176

About this trial

This is an interventional treatment trial for Alzheimer Type Dementia focused on measuring Alzheimer disease

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Whanin Pharm.Co.,Ltd.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Aricept

INM-176

Arm Description

Intervention: Drug: Aricept

Intervention: Drug: INM-176

Outcomes

Primary Outcome Measures

Change in cognition as assessed by the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) total score

Secondary Outcome Measures

Change from baseline to endpoint in Mini-Mental State Examination (MMSE)

Change from baseline to endpoint in Clinical Dementia Rating

Change from baseline to endpoint in Global Deterioration Scale(GDS)

Change from baseline to endpoint in Korean Activity of Living(K-IADL)

Change from baseline to endpoint in Korean Neuropsychiatric Inventory (NPI)

Full Information

NCT ID

NCT01245530

First Posted

November 1, 2010

Last Updated

June 9, 2011

Sponsor

Whanin Pharmaceutical Company

1. Study Identification

Unique Protocol Identification Number

NCT01245530

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

June 2011

Overall Recruitment Status

Completed

Study Start Date

June 2008 (undefined)

Primary Completion Date

February 2011 (Actual)

Study Completion Date

March 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Whanin Pharmaceutical Company

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer Type Dementia

Keywords

Alzheimer disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

280 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Aricept

Arm Type

Active Comparator

Arm Description

Intervention: Drug: Aricept

Arm Title

INM-176

Arm Type

Experimental

Arm Description

Intervention: Drug: INM-176

Intervention Type

Drug

Intervention Name(s)

Aricept

Other Intervention Name(s)

Donepezil HCl

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

INM-176

Other Intervention Name(s)

KR-WAP-026

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in cognition as assessed by the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) total score

Time Frame

up to 24 weeks

Secondary Outcome Measure Information:

Title

Change from baseline to endpoint in Mini-Mental State Examination (MMSE)

Time Frame

up to 24 weeks

Title

Change from baseline to endpoint in Clinical Dementia Rating

Time Frame

up to 24 weeks

Title

Change from baseline to endpoint in Global Deterioration Scale(GDS)

Time Frame

up to 24 weeks

Title

Change from baseline to endpoint in Korean Activity of Living(K-IADL)

Time Frame

up to 24 weeks

Title

Change from baseline to endpoint in Korean Neuropsychiatric Inventory (NPI)

Time Frame

up to 24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

SangYoon Kim, MD

Organizational Affiliation

Seoul National University Bundang Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Whanin Pharm.Co.,Ltd.

City

Seoul

State/Province

Moonjung

ZIP/Postal Code

138-200

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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