NCT01035164已完成1 期
Open-label, Non-randomized, Positron Emission Tomography (PET) Imaging Study to Evaluate a Single Dose of 250 MBq (6.75 mCi) ZK 6032924 (18F-FEDAA1106) for Its Diagnostic Potential in Discriminating Patients With Probable Alzheimer's Disease From Healthy Volunteers and to Evaluate the Radiation Dosimetry of a Single Dose of 185 MBq (5 mCi) ZK 6032924 in Healthy Volunteers.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 25
- 主要终点
- Standardized uptake value (SUV) in various cerebral regions/volumes of interest (ROI/VOI) assumed and found to be involved in the pathophysiology of Alzheimer's disease.
研究概览
简要总结
PET (positron emission tomography) imaging with BAY85-8101 (ZK 6032924) in patients with Alzheimer's Disease compared to healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients for brain imaging:- patient and designee capable of giving fully informed consent in writing- patient fulfils DSM-IV and NINCDS-ADRDA criteria for probable Alzheimer's disease. Other forms of dementia excluded- males or postmenopausal females aged >/= 50 yearsHealthy volunteers for brain imaging: - able to give fully informed consent in writing- absence of any sign of dementia/cognitive impairment in neuropsychological examinations- males or postmenopausal females aged >/= 50 years Healthy volunteers for whole body imaging:- able to give fully informed consent in writing - males or postmenopausal females aged >/= 60 years - no significant disease or drug use
排除标准
- •For all healthy volunteers and patients:- Any disease, condition, or concomitant medications that significantly compromises the function of the body systems and could result in excessive accumulation, impaired metabolism, altered excretion of the radiotracer, or might interfere with the conduct of the study or interpretation of the results
研究组 & 干预措施
Arm 1
Experimental
干预措施: F-18 FEDAA1106 (BAY85-8101) (Drug)
Arm 2
Experimental
干预措施: F-18 FEDAA1106 (BAY85-8101) (Drug)
Arm 3
Experimental
干预措施: F-18 FEDAA1106 (BAY85-8101) (Drug)
结局指标
主要结局
Standardized uptake value (SUV) in various cerebral regions/volumes of interest (ROI/VOI) assumed and found to be involved in the pathophysiology of Alzheimer's disease.
时间窗: Day of study tracer administration
Visual analysis/description of the uptake and description of brain PET scans
时间窗: Day of study tracer administration
次要结局
- Standard quantification variables derived from 3D PET imaging and brain modeling(Day of study tracer administration)
- Standard Safety Measurement:adverse event collection(Maximum time from Screening to Follow up are 37 days)
- Standard Safety Measurement:electrocardiogram(Maximum time from Screening to Follow up are 37 days)
- Standard Safety Measurement: vital signs(Maximum time from Screening to Follow up are 37 days)
- Standard Safety Measurement:safety laboratory(Maximum time from Screening to Follow up are 37 days)
研究者
相似试验
已完成
1 期
Evaluation of the Positron Emission Tomography (PET) Tracer ZK 6032924 in Patients With Multiple Sclerosis Compared to Healthy VolunteersPositron-Emission TomographyMultiple SclerosisNCT01031199Bayer16
已完成
1 期
Evaluation of the Neuroinflammation Pattern of BAY85-8102 F-18, DPA-714 in Probable Alzheimers Disease Patients Versus Healthy Volunteers and Radiation Dosimetry of F 18, DPA-714 in Healthy VolunteersDiagnostic ImagingNCT01009359Bayer22
尚未招募
不适用
Diagnosis of Alzheimer disease using 11C-PIB PETs diseaseAlzheimer's diseaseJPRN-UMIN000015607kyushu university hospital100
招募中
不适用
F 18 T807 Tau PET Imaging of Alzheimer's DiseaseAlzheimer DiseaseNCT02414347Tammie L. S. Benzinger, MD, PhD900
招募中
不适用
Investigation of Inflammation in Alzheimer's Disease and Related Dementias (ADRD) Using [11C]-CS1P1Alzheimer DiseaseNCT06129838Washington University School of Medicine80