2024-510601-29-00招募中4 期
ADAPT: Treatment of Agitated behaviour in patients with Dementia non-responsive to guideline recommended interventions by Argued Personalised Treatment using an N-of-1 approach
Amsterdam UMC19 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年4月7日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 19
- 主要终点
- Agitation over time measured on the Cohen Mansfield Agitation Inventory (CMAI) under psychotropic drug treatment (quetiapine, olanzapine or lorazepam) compared to placebo treatment.
研究概览
简要总结
The main objective is to determine the effectiveness of psychotropic drugs not recommended by guidelines on agitated behaviour in patients with dementia.
入排标准
- 年龄范围
- 65 years 至 65+ years（65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Nursing home resident with dementia and agitated behaviour
- •The treating physician has decided to prescribe quetiapine, olanzapine or lorazepam, in shared decision making with the patient and/or representative, independently of this trial.
排除标准
- •A life expectancy of <4 weeks, as estimated by the physician
- •Inability to swallow the study capsules, assessed by the physician
- •Actual alcohol and/or drug abuse
- •The agitated behaviour is too unstable, as estimated by the physician
- •Insufficient mastery of Dutch language, also applies to representatives if they provide informed consent
- •The agitated behaviour is only present at night
结局指标
主要结局
Agitation over time measured on the Cohen Mansfield Agitation Inventory (CMAI) under psychotropic drug treatment (quetiapine, olanzapine or lorazepam) compared to placebo treatment.
Agitation over time measured on the Cohen Mansfield Agitation Inventory (CMAI) under psychotropic drug treatment (quetiapine, olanzapine or lorazepam) compared to placebo treatment.
次要结局
- Agitation over time measured on the Clinical Global Impression of Severity (CGI-S) and the Clinical Global Impression of Change (CGI-C) under psychotropic drug treatment (quetiapine, olanzapine or lorazepam) compared to placebo treatment.
- Frequency, severity, and burden of targeted agitated behaviour over time under psychotropic drug treatment (quetiapine, olanzapine or lorazepam) compared to placebo treatment.
- The incidence and severity of side effects under psychotropic drug treatment (quetiapine, olanzapine or lorazepam) compared to placebo treatment.
研究者
Eefje Sizoo
Scientific
Amsterdam UMC
研究点 (19)
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