Cerebral Amyloid Imaging Using Florbetapir (18F-AV-45) for the Etiological Diagnosis of Poststroke Cognitive Impairment and Dementia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- presence of positive amyloid retention
研究概览
简要总结
This study is aimed at examining the interest of amyloid radiotracer Florbetapir (18F-AV-45) for the etiological diagnosis of poststroke cognitive impairment and dementia
详细描述
This study is aimed at examining the interest of amyloid radiotracer Florbetapir (18F-AV-45) for the etiological diagnosis of poststroke cognitive impairment and dementia. This study stems from two converging objectives: (1) the need to refine characteristics of vascular cognitive impairment (VCI) and dementia (VD) in order to propose diagnosis criteria of VCI and of mixed dementia and to improve diagnosis criteria of VD and (2) the need to improve the etiological diagnosis of poststroke cognitive impairment and dementia. It will take advantage from the ongoing GRECOG-VASC study (which determines the cognitive status 6 months poststroke in consecutive patients according to a standardized international battery) coordinated by the Amiens University Hospital center, the opportunity to perform amyloid imaging in vivo using Positron Emission Tomography (PET) and Florbetapir (a production site is located in the city of Amiens) and the collaboration between neurology and imaging departments of Amiens University hospital.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients suffering of parenchymal stroke visualized by imaging (MRI),
- •patients suffering from cognitive impairment on the 6 months assessment (including GRECogVASC patients),
- •age between 40 and 80 years,
- •French-speaking,
- •reliable informant,
- •agreeing to participate in the study,
- •affiliation to a social security system,
排除标准
- •women of childbearing potential (defined as pre-menopausal, less than 2 years postmenopausal, or not surgically sterile), or who are breast-feeding
- •history of relevant severe drug allergy or hypersensitivity,
- •patient receiving any investigational medications at least in the 30 last days,
- •stroke affecting the cerebellum,
- •mental retardation,
- •illiteracy,
- •dementia diagnosed before stroke,
- •history of schizophrenia or psychiatric illness requiring a stay for > 2 days in a psychiatry unit,
- •persons placed under judicial protection,
- •comorbidities affecting cognition (respiratory, renal, liver, heart failure),
- •persistent disturbance of consciousness defined by a score to item 1a of the National Institute of Health Stroke Scale (NIHSS) ≤ 1,
- •contraindication to MRI.
研究组 & 干预措施
Florbetapir
干预措施: florbetapir (Biological)
结局指标
主要结局
presence of positive amyloid retention
时间窗: 12 months
determine the frequency of abnormal amyloid retention using PET with 18F-AV-45 on patients with poststroke cognitive impairment
次要结局
- Final diagnosis(12 months)