DRKS00009915已完成4 期
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. - SAPP Demenz
niversitätsklinikum Erlangen0 个研究点目标入组 68 人开始时间: 2016年1月22日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 68
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 45 Years 至 90 Years（—）
- 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 healthy 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;
排除标准
- •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;
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