跳至主要内容
临床试验/EUCTR2018-002548-10-IT
EUCTR2018-002548-10-IT进行中(未招募)1 期

PET/MRI study of amyloid burden in patients with Cerebral Amyloid Angiopathy-related inflammation - CAA AMY

OSPEDALE SAN RAFFAELE0 个研究点目标入组 10 人开始时间: 2021年5月24日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
10

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
Male

入选标准

  • male patients; diagnosis of CAA-RI; age>55 years.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 3
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 7

排除标准

  • Evidence of focal cerebral, physical, psychiatric or metabolic disorders that may otherwise account for the cognitive disturbances; patients with hepatic or renal insufficiency; hypersensitivity to the active substance or to any of the following excipients: ascorbic acid, ethanol anhydrous, macrogol 400, sodium ascorbate, water for injections; wearers of pacemakers, clips or metal prostheses; contraindications to PET and MRI.
  • This medicine contains up to 1.5 mmol sodium (ie 33 mg) per dose. This must be taken into consideration in patients on a low sodium diet.
  • This medicine contains 15% by volume of ethanol (alcohol), that is up to 1.2 g per dose equivalent to 30 mL of beer or 12.5 mL of wine. This can be dangerous for those suffering from alcoholism, and must also be taken into consideration in high-risk groups such as patients with liver disease or epilepsy.

研究者

发起方
OSPEDALE SAN RAFFAELE

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