NCT01245530已完成3 期
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
Whanin Pharmaceutical Company1 个研究点 分布在 1 个国家目标入组 280 人开始时间: 2008年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Change in cognition as assessed by the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) total score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Aricept
Active Comparator
Intervention: Drug: Aricept
干预措施: Aricept (Drug)
INM-176
Experimental
Intervention: Drug: INM-176
干预措施: INM-176 (Drug)
结局指标
主要结局
Change in cognition as assessed by the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) total score
时间窗: up to 24 weeks
次要结局
- 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)
研究者
研究点 (1)
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