Clinical trial NCT01245530: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alzheimer Type Dementia
Keywords: Alzheimer disease
Lead sponsor: Whanin Pharmaceutical Company
Sponsor class: INDUSTRY
First posted: 2010-11-22
Enrollment: 280
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in cognition as assessed by the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) total score
timeFrame: up to 24 weeks
Secondary outcomes:
measure: Change from baseline to endpoint in Mini-Mental State Examination (MMSE)
timeFrame: up to 24 weeks
measure: Change from baseline to endpoint in Clinical Dementia Rating
timeFrame: up to 24 weeks
measure: Change from baseline to endpoint in Global Deterioration Scale(GDS)
timeFrame: up to 24 weeks
measure: Change from baseline to endpoint in Korean Activity of Living(K-IADL)
timeFrame: up to 24 weeks
measure: Change from baseline to endpoint in Korean Neuropsychiatric Inventory (NPI)
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Whanin Pharm.Co.,Ltd.
state: Moonjung
Study officials:
affiliation: Seoul National University Bundang Hospital
name: SangYoon Kim, MD
role: PRINCIPAL_INVESTIGATOR
References: