An Open-Label Trial Of Donepezil in Vascular and Mixed Dementia
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 149
- 试验地点
- 1
- 主要终点
- Change in Total Score of Standardized Mini-Mental State Examination (sMMSE); Full Analysis Set
研究概览
简要总结
To document effectiveness, safety, and tolerability of donepezil in patients with mixed AD/VaD, and to further document the effectiveness, safety, and tolerability of donepezil in patients with VaD. The effects of donepezil on executive functioning, behavior, general cognition, ADLs and global functioning will be assessed.
详细描述
The trial was terminated on October 15, 2007 due to difficulties in recruiting the subjects. There were no safety or efficacy concerns regarding the study medication in the decision to terminate the trial.
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
- 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
- •Subjects must meet DSM-IV-TR criteria for the clinical diagnosis of Vascular Dementia or the clinical diagnosis of dementia due to multiple etiologies.
- •Subjects must have a reliable caregiver or family member who agrees to accompany the subject to all scheduled visits, provide information about the subject as required.
排除标准
- •Subjects with any current primary psychiatric diagnosis other than dementia of the Alzheimer's type or Vascular Dementia.
研究组 & 干预措施
1
干预措施: Donepezil (Drug)
结局指标
主要结局
Change in Total Score of Standardized Mini-Mental State Examination (sMMSE); Full Analysis Set
时间窗: Baseline, week 12, week 24
Change from baseline in sMMSE total score. Change: mean total score at observation minus mean total score at baseline. Total score is derived by adding all subscores and ranges from 0 to 30; a higher score indicates a better cognitive state.
次要结局
- Disability Assessment for Dementia (DAD) Change From Baseline Total Score; Full Analysis Set (FAS)(Baseline, week 12, week 24)
- Copied Clock Drawing Test (CLOX 2) Change From Baseline; Full Analysis Set (FAS)(Baseline, 12 weeks, 24 weeks)
- Neuropsychiatric Inventory Questionnaire (NPI-Q) Score Change From Baseline; Full Analysis Set (FAS)(Baseline, 12 weeks, 24 weeks)
- CLOX Differential Score Change From Baseline; Full Analysis Set (FAS)(Baseline, 12 weeks, 24 weeks)
- Phonectic Fluency Total Score From Baseline; Full Analysis Set (FAS)(Baseline, 12 weeks, week 24)
- Clinical Global Impressions Severity Score (CGI-S) Clinical Global Impressions Severity Score Improvement(CGI-I)Change From Baseline, Full Analysis Set (FAS)(Baseline, week 24)
- Clinical Global Impressions Improvement (CGI-I)(Week (wk) 24)
- Disability Assessment for Dementia Change From Baseline; Activities of Daily Living (ADL) Domain.(Baseline, week 12, week 24)
- Disability Assessment for Dementia Change From Baseline; Instrumental ADL (IADL) Domain.(Baseline, 12 weeks, 24 weeks)
- Free-hand Drawing Test (CLOX 1) Change From Baseline; Full Analysis Set (FAS)(Baseline, 12 weeks, 24 weeks)
- Neuropsychiatric Inventory Questionnaire Distress (NPI-Q-D) Score Change From Baseline; Full Analysis Set (FAS)(Baseline, week 12, week 24)
- Clinical Global Impressions Severity (CGI-S)(Baseline)
- Clinical Global Impressions Improvement (CGI-I) Dichotomized Response(Baseline, week 24)