NCT01029132已完成不适用
Characteristics of Treatment Responders to Galantamine Administration in the Patients With Alzheimer's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Alzheimer's Disease Assessment Scale-cognitive subscale-preliminary Korean version (ADAS-cog-K)
研究概览
简要总结
To investigate the characteristics of treatment responders to galantamine.
详细描述
The purposes of this study are:
- to investigate the characteristics of treatment responders to galantamine by examining the clinical response of galantamine in patients with mild to moderate AD for 52 weeks.
- to examine the specific cognitive sub-domains that are more sensitive to galantamine administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of probable AD according to the criteria of the NINCDS-ADRDA
- •Korean version Mini-Mental State Examination scores between 10 and 26
- •History of cognitive decline that had been gradual in onset and progressive over at least 6 months
- •A caregiver who could assist the patient with medication, attend the assessment and provide information about the patient.
排除标准
- •they had evidence of any neurodegenerative diseases other than AD (i.e. Parkinson's disease, Huntington's disease)
- •Psychiatric disorder or severe behavioral disturbances that required psychotropic medications
- •Cerebral injuries induced by trauma, hypoxia, and/or ischemia
- •Clinically active cerebrovascular disease; History of seizure disorder
- •Other physical conditions that required acute treatment.
研究组 & 干预措施
non-responder group
Experimental
patients who did not maintained or improved cognitive function
干预措施: galantamine (Drug)
responder group
Experimental
patients who maintained or improved cognitive function
干预措施: galantamine (Drug)
结局指标
主要结局
Alzheimer's Disease Assessment Scale-cognitive subscale-preliminary Korean version (ADAS-cog-K)
时间窗: baseline, 4w, 13w, 26w, 39w, 52w
次要结局
- Seoul-Activities of Daily Living (S-ADL) Seoul-Instrumental Activities of Daily Living (S-IADL) Korean version Neuropsychiatric Inventory (K-NPI)(baseline, 4w, 13w, 26w, 39w, 52w)
研究者
Doh Kwan Kim
Principal Investigator
Samsung Medical Center
研究点 (1)
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