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临床试验/EUCTR2012-001583-29-DE
EUCTR2012-001583-29-DE进行中（未招募）不适用

Prospective, open-label, two-arm, parallel-group, single center phase IV clinical trial to evaluate the diagnostic value of a Gadobutrol enhanced dynamic susceptibility perfusion MRI (DSC-MRP) and a non contrast arterial spin labeling perfusion MRI (ASL-MRP) in subjects with minor cognitive impairment or minor Alzheimer's disease compared to age matched mentally healthy subjects

niversity Hospital Erlangen0 个研究点开始时间: 2012年7月12日最近更新:
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适应症
相关药物

试验速览

阶段
不适用
状态
进行中（未招募）
发起方
研究概览入排标准研究者记录与标识符相似试验

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
All

入选标准

  • •1.Adult subjects, age >45 years
  • •2.Subjects with symptoms of MCI or minor AD referred for diagnostic work-up with MRI -
  • •or mentally healtyh control subjects in the same age range.
  • •3.Willing to undergo all study procedures
  • •4.Subjects who have completed a neuropsychologic assessment or a MMSE with a score that allows full understanding of the study procedures and ability to give informed consent – for control subjects a normal MMSE is required.
  • •5.Subject has voluntarily given written informed consent
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) no
  • •F.1.2.1 Number of subjects for this age range
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 50

排除标准

  • •1. 1.Having any physical or mental status that interferes with the informed consent procedure including self-signed consent
  • •2.Having an underlying disease or concomitant medication which may interfere with efficacy or safety evaluations as planned in this study.
  • •3.GFR <60ml/m²/1.73m² (MDRD) as determined from a serum creatinine value not older than 1 week before MR contrast media injection, or subjects on hemodialysis
  • •4.Renal or liver transplant subjects, including subjects with scheduled liver transplant are excluded due to the potential risk for nephrogenic systemic fibrosis (NSF)
  • •5.MR contraindications (pacemaker, magnetic clips, severe claustrophobia)
  • •6.Known allergy to Gadobutrol
  • •7.Subjects presenting with a history of anaphylactoid or anaphylactic reaction to any allergen including drugs and contrast medias
  • •8.Having received any investigational drug within 7 days prior to entering this study.
  • •9.Not being able to remain lying down for at least 30-45min (e.g. subjects with unstable angina, dyspnea at rest, severe pain at rest, severe back pain)
  • •10.Close affiliation with the investigational site; e.g. a close relative of the investigator or staff members of the coordinating investigators department.
  • •11.Having been previously enrolled in this clinical trial.
  • •12.Women who are pregnant, lactating or who are of childbearing potential and have not had a negative urine pregnancy test the same day as administration of the investigational contrast media. The manufacturer’s instructions for performing the urinary pregnancy test are to be followed.

研究者

发起方
niversity Hospital Erlangen

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