A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase IIb, Clinical Study to Evaluate the Safety and Efficacy of DHP1401 in Patients With Mild-moderate Alzheimer's Disease Treated With Donepezil(DRAMA)

Daehwa Pharmaceutical Co., Ltd.16 个研究点分布在 1 个国家目标入组 180 人开始时间: 2016年12月28日最近更新: 2019年8月20日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: Daehwa Pharmaceutical Co., Ltd.
入组人数: 180
试验地点: 16
主要终点: Alzheimer's Disease Assessment Scale-cognition Korean version(ADAS-cog)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The objective of this study is to evaluate the efficacy and safety of DHP1401 in patients with mild-moderate Alzheimer's disease treated with donepezil

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: Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围: 55 Years 至 85 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•≥55 and ≤85 years of age
•Patient who was diagnosed mild to moderate Alzheimer's disease by National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association(NINCDS-ADRDA) or National Institute on Aging-Alzheimer's Association(NIAAA)
•Korean Mini-Mental State Examination(K-MMSE) score 15 to 26
•Patient who maintained on donepezil without dose escalation or reduction for at least during 3 months before screening (visit 1)
•Clinical Dementia Rating(CDR) score 0.5 to 2.0 at screening (visit 1)
•Written informed consent voluntarily
•Patient who has a relative/caregiver who support the information of patient's status
•Patient who are deemed adequate to participate in the clinical trial by the investigator
•Infertility or patients and his/her spouse consent with contraception during the study period

排除标准

•A diagnosis of vascular dementia or dementia by other cause according to the criteria of the NINCDS-ADRDA
•Structural brain abnormality or impairment
•Schizophrenia, depressive disorder and bipolar disorder
•Any neurological disease except Alzheimer' disease (ex. Parkinson's disease, Huntington's disease, brain tumor, normal-pressure hydrocephalus, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, epilepsy, delusion and head injury required hospitalization)
•History of any cancer within previous 5 years
•History of stroke within previous 2 years
•Heart failure required medication or interventional treatment including myocardial infarction, valvular heart disease, arrhythmia within previous 1 year
•Uncontrollable diabetes
•Uncontrollable hypertension
•Abnormal liver or kidney function
•Patient with significant clinical meaning to affect cognitive function
•Patient who participated in other clinical trial within previous 3 months or has a plan to participate in other clinical trial during study period
•History of abuse of a drug or alcohol within previous 2 years
•Patient who has administrated other acetylcholinesterase inhibitors except donepezil within previous 4 weeks
•Patient who are deemed inadequate to participate in the clinical trial by the investigator(ex. a illiteracy, etc.)
•History of hypersensitivity reaction to the main ingredient of the investigational drugs
•Patient who has administrated other drugs except donepezil for dementia treatment (it is possible to enroll after washout for 28 days)