Rationalisation of Antipsychotic Drug Use in Older People, Using [18F]-Fallypride PET
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- dose titration
研究概览
简要总结
Drugs such as amisulpride, known as antipsychotic drugs, are used to treat troublesome and distressing symptoms in older people. Although these drugs can be beneficial, they are associated with side effects, particularly in patients with dementia and schizophrenia- like illness. There is an urgent clinical need to understand why this is the case, to guide treatment strategies.
This study aims to utilise brain imaging techniques that measure the action of antipsychotic drugs in the brain to explore the causes of this susceptibility in older people with dementia and schizophrenia-like illness, and translate these findings into direct patient benefit.
The aim of the study is to investigate and compare the relationship between the action of amisulpride at brain sites during the first 10 weeks of amisulpride treatment in two patient groups - Alzheimer's disease and schizophrenia-like illness. Imaging data will be combined with data on drug dosage, levels of drug in the bloodstream and clinical response (symptom reduction and motor side effects) during dose titration.Dose-response modelling will be carried out in both groups to establish the minimum clinically effective dose of amisulpride, optimum dose range and impact of variability and covariates on exposure-response relationships
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
- 60 Years 至 95 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
Patients - dose titration
Amisulpride 50-200mg, 4-12 weeks, with brain imaging
干预措施: Patients- dose titration (Drug)
结局指标
主要结局
dose titration
时间窗: 12 weeks
receptor occupancy compared across 2 patient groups following dose-titration
次要结局
未报告次要终点
研究者
Suzanne Reeves
Clinician Scientist
Institute of Psychiatry, London
