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

NCT01245530 | Completed Phase 3 DMC

• 1 other identifier: INM-176
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Type Dementia

Keywords

Alzheimer disease

Outcome Measures

Primary Outcomes (1)

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

  up to 24 weeks

Secondary Outcomes (5)

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

  up to 24 weeks

• Change from baseline to endpoint in Clinical Dementia Rating

  up to 24 weeks

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

  up to 24 weeks

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

  up to 24 weeks

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

  up to 24 weeks

Study Arms (2)

Aricept

ACTIVE COMPARATOR

Intervention: Drug: Aricept

Drug: Aricept

INM-176

EXPERIMENTAL

Intervention: Drug: INM-176

Drug: INM-176

Interventions

Aricept DRUG

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

Also known as: Donepezil HCl

Aricept

INM-176 DRUG

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

Also known as: KR-WAP-026

INM-176

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Whanin Pharmaceutical Company: lead

Study Sites (1)

Whanin Pharm.Co.,Ltd.

Seoul, Moonjung, 138-200, South Korea

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Donepezil

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Officials

• SangYoon Kim, MD

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 1, 2010
• First Posted: November 22, 2010
• Study Start: June 1, 2008
• Primary Completion: February 1, 2011
• Study Completion: March 1, 2011
• Last Updated: June 13, 2011

Record last verified: 2011-06

Locations

KR (1)