An Observational, Multi-Center Study to Demonstrate That the Change of Attention Measure is Correlated With the Changes of Caregiver's Burden After Treatment With Galantamine in Patients With Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,882
- 主要终点
- Change From Baseline at Week 16 in Attention Questionnaire Scores (AQS)
研究概览
简要总结
The purpose of this study is to demonstrate that the change of attention measure is correlated with the changes of caregiver's burden after treatment with galantamine.
详细描述
This is an open-label (all people know the identity of the intervention), prospective (in which the participants are first identified and then followed forward as time passes), observational (study in which the investigators/ physicians observe the patients and measure their outcomes), multi-center (study conducted at multiple sites) study. The study mainly consists of 2 phases including, the screening phase (14 days before administration of study medication) and treatment phase (16 weeks). In the treatment phase, patients will receive galantamine 8 mg/day for the first 4 weeks and later on the dose will be increased up to 24mg (if tolerable). Safety evaluations will include assessment of adverse events. The total duration of the study will be 18 weeks.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Alzheimer's disease according to the criteria of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), National Institute of Neurological and Communicative Diseases and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA)
- •Measuring standard: K-MMSE is 10 to 24
- •Patient with reliable Guardian
排除标准
- •Patients with brain tumor, nerve syphilis, meningitis, encephalitis, epilepsy
- •Major psychiatric patients such as major depression and schizophrenia
- •Patients with treatment-resistant gastric and peptic ulcer
- •Patients with clinically serious hepatic, renal, lung, endocrinal or metabolic disease (thyroid, parathyroid, pituitary, renal failure, diabetes mellitus)
研究组 & 干预措施
Galantamine
Patients will receive galantamine 8 mg/day for the first 4 weeks and the dose of galantamine will be increased up to 24 mg (if tolerable).
干预措施: Galantamine (Drug)
结局指标
主要结局
Change From Baseline at Week 16 in Attention Questionnaire Scores (AQS)
时间窗: Baseline (Week 1 [Day 1]), Week 16
AQS evaluates the attention of participants with dementia and is designed for their caregivers to evaluate the participant's attention directly. It has 15 questions devised to be suitable for cultural characteristics of Korea through the standardization study considering education and gender/culture gap. Each question is scored from 0 to 2 (0=never, 1=occasionally, 2=usually). In questions 1 to 8, the lower participant attention ability rated the higher score (AQS1), In questions 9 to 15, the higher participant attention ability rated the higher score (AQS2). The total score is calculated by the formula: 16-AQS1+AQS2 and the range is from 0 to 30. Higher score means better attention ability of participant.
Change From Baseline at Week 16 in Burden Interview (BI) Scores
时间窗: Baseline, Week 16
BI is designed to evaluate subjective stress dementia patients' caregivers experience in relation to caregiving. It has total 22 questions with 4 options each and the calculated scores are from 1 to 88 (0-20 = Little or no burden, 21-40 = Mild to moderate burden, 41-60 = Moderate to severe burden, 61-88 = Severe burden). Higher scores indicate worsening.
次要结局
- Change From Screening at Week 16 in Mini Mental State Exam Scores (MMSE)(Baseline, Week 16)