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:
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
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
相似试验
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.MCI and minor Alzheimer´s disease (AD)F03Unspecified dementiaDRKS00009915niversitätsklinikum Erlangen68
进行中（未招募）
1 期
Efficacy and safety of LNP023 compared with rituximab in subjects with idiopathic membranous nephropathy.Idiopathic Membranous nephropathyMedDRA version: 21.1Level: LLTClassification code 10027170Term: Membranous nephropathySystem Organ Class: 100000004857EUCTR2019-001734-34-NLovartis Pharma AG52
已完成
不适用
Bacterial contamination of antibacterial contact lens cases during daily wear of marketed contact lensesACTRN12609000165280Institute for Eye Research40
已完成
Unknown
A Phase 1 Study to Compare the Pharmacokinetics and Safety of CT-P13 (CT-P13 SC) Auto-injector and Pre-filled Syringe for Subcutaneous Administration in Healthy Adult SubjectsKCT0009574Celltrion148
进行中（未招募）
1 期
Efficacy and safety of LNP023 compared with rituximab in subjects with idiopathic membranous nephropathy.Idiopathic Membranous nephropathyMedDRA version: 21.1Level: LLTClassification code 10027170Term: Membranous nephropathySystem Organ Class: 100000004857EUCTR2019-001734-34-DEovartis Pharma AG52