Prospective, Single-arm, Multi-centre, Open-label Study to Investigate the Potential to Reduce Concomitant Antipsychotics Use in Patients With Moderate to Severe Dementia of Alzheimer's Type (DAT) Treated With Memantine
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Maximum Dose Reduction of Antipsychotics (AP) in Percent of Defined Daily Dose (DDD) From Baseline to a Post-baseline Visit at Which the Value of the Visual Analogue Scale (VAS) Compared With the Baseline Value Was =< 15 Percent.
研究概览
简要总结
To investigate the potential to reduce concomitant antipsychotic medication use in subjects with moderate dementia of Alzheimer's type, treated with memantine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Memantine
干预措施: Memantine (Drug)
结局指标
主要结局
Maximum Dose Reduction of Antipsychotics (AP) in Percent of Defined Daily Dose (DDD) From Baseline to a Post-baseline Visit at Which the Value of the Visual Analogue Scale (VAS) Compared With the Baseline Value Was =< 15 Percent.
时间窗: Week 8-20 post baseline
VAS: see #8. Mean "percent of the total Defined Daily Dose (DDD)", averaged over one week, was calculated. Total DDD was calculated as sum of DDD for each AP drug. DDD is the assumed average maintenance dose per day defined by WHO. The reduction of AP Δ \[percent\] was calculated as a difference between the mean total DDD recorded at baseline and the mean total DDD recorded at the respective week. Measurements from those post-baseline visits were taken into account only when the value of the VAS was not substantially worse compared to baseline.
次要结局
- Reduction of Antipsychotic Drug Dose From Baseline to Week 8, 12, 16 and/or 20.(Week 8-20 post Baseline)
- Change in the Mini-Mental State Examination (MMSE) Score Value From Baseline to Week 20.(Week 20 post baseline)
- Change of "Test for the Early Detection of Dementia With Discrimination From Depression [TE4D]" Score Value From Baseline to Week 4, 8, 12, 16, and/or 20 - First Part: Total Dementia(Week 4-20 post baseline)
- Change of "Test for the Early Detection of Dementia With Discrimination From Depression [TE4D]" Score Value From Baseline to Week 4, 8, 12, 16, and/or 20 - Second Part: Total Depression(Week 4-20 post Baseline)
- Change of Modified Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADLB19) Score Value From Baseline to Week 4, 8, 12, 16, and/or 20.(Week 4-20 post Baseline)
- Change of Nurses' Observation Scale for Geriatric Patients [NOSGER] Total Score Value From Baseline to Week 4, 8, 12, 16, and/or 20(Week 4-20 post Baseline)
- Change in the VAS Score From Baseline to Week 8, 12, 16 and/or 20.(Week 8-20 post Baseline)