Quality Of Life Assessment In AD Patients Receiving Aricept Tablets (Donepezil Hydrochloride)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 628
- 试验地点
- 29
- 主要终点
- Number of Participants for Change From Baseline for Clinical Global Impressions of Improvement (CGI-I) at Week 12
研究概览
简要总结
This study assessed the Hr QoL (Health related Quality of life) of subjects with mild to moderate AD, who received ARICEPT under usual clinical practice.
详细描述
This non-interventional study enrolled patients with mild to moderate dementia of the Alzheimer's type, who have been prescribed treatment with ARICEPT under usual clinical practice.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Alzheimer's Disease
排除标准
- •There are no exclusion criteria
结局指标
主要结局
Number of Participants for Change From Baseline for Clinical Global Impressions of Improvement (CGI-I) at Week 12
时间窗: Baseline, Week 12.
CGI-I is a 7-point physician rated scale ranging from very much improved to very much worse.
Number of Participants for Change From Baseline for the Caregiver's Assessment of Improvement at Week 12
时间窗: Baseline, Week 12.
The caregiver's assessment improvement was a 5-point rated scale ranging from much improved to much worse to the question 'compared to the severity of your relative's condition at baseline, how much do you feel it has changed?'.
Change From Baseline in the Participant's Assessment for Quality of Life for Alzheimer's Dementia (QoL-AD) Overall and Subscale Scores at Week 12
时间窗: Baseline, Week 12.
QoL-AD was comprised of 13 individual items, each measured on a 4-point Likert scale (ranging from 1 \[poor\] to 4 \[excellent\]). Overall QoL-AD score was the sum of the scores for the 13 individual items and ranged from 13 to 52, with higher scores indicating a higher health related quality of life.
Change From Baseline in the Caregiver's Assessment for Quality of Life for Alzheimer's Dementia (QoL-AD) Overall and Subscale Scores at Week 12
时间窗: Baseline, Week 12.
QoL-AD was comprised of 13 individual items, each measured on a 4-point Likert scale (ranging from 1 \[poor\] to 4 \[excellent\]). Overall QoL-AD score was the sum of the scores for the 13 individual items and ranged from 13 to 52, with higher scores indicating a higher health related quality of life.
次要结局
- Change in ARICEPT Dosing: Number of Participants for Time to First ARICEPT Dose Escalation(Baseline to Week 12.)
- Change in ARICEPT Dosing: Number of Participants at Each Final Dose of ARICEPT(Week 12.)
- Number of Participants for the Physician's Assessment of Tolerance to ARICEPT at Week 12(Baseline to Week 12.)