NCT01153607已完成1 期
Open-label, Non-randomized, Multicenter Positron Emission Tomography (PET) Imaging Study to Evaluate a Single Dose of BAY1006578 for Its Diagnostic Potential in Discriminating Patients With Probable Alzheimers Disease From Healthy Volunteers and to Evaluate the Radiation Dosimetry of a Single Dose of BAY1006578 in Healthy Volunteers
Life Molecular Imaging SA0 个研究点目标入组 24 人开始时间: 2010年6月最近更新:
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
- 入组人数
- 24
- 主要终点
- Discrimination of probable Alzheimer's Disease patients from healthy volunteers by BAY1006578 brain Positron Emission Tomography (PET) imaging as evaluated by different quantification approaches
研究概览
简要总结
PET (positron emission tomography) imaging with BAY1006578 for investigation of diagnostic potential in probable Alzheimer Disease patients versus healthy volunteers and radiation dosimetry in 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
- •Males or females aged >/- 50 years
- •Participants must be able to understand the information provided on purpose and conduct of the clinical study, must be capable of giving fully informed consent in writing, and have read and signed the informed consent prior to study participation
- •Healthy volunteers for brain imaging:
- •Mini-Mental State Examination (MMSE) score of >/= 28
- •CDR score of zero (0)
- •Patients for brain imaging:
- •Patient fulfills Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) and National Institute of Neurological and Communicative Disorders and Stroke, Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria for probable Alzheimer's Disease (AD), which are cognitive deficits such as memory decline and impairment in at least one other cognitive domain (e.g. aphasia, apraxia, agnosia or executive dysfunction)
- •Patient has mild to moderate dementia with a dementia score of >/= 20 on the Mini Mental State Examination (MMSE) / with a Clinical Dementia Rating score of 1 or 2 (CDR)
排除标准
- •No significant disease or drug use
- •Patients for brain imaging:
- •Evidence for any other neurological or psychiatric disease
- •Healthy volunteers for brain imaging:
- •Family history of Alzheimer's Disease in a 1st or 2nd degree relative under 75 years of age
研究组 & 干预措施
Arm 1
Experimental
干预措施: BAY1006578 (Drug)
Arm 2
Experimental
干预措施: BAY1006578 (Drug)
Arm 3
Experimental
干预措施: BAY1006578 (Drug)
结局指标
主要结局
Discrimination of probable Alzheimer's Disease patients from healthy volunteers by BAY1006578 brain Positron Emission Tomography (PET) imaging as evaluated by different quantification approaches
时间窗: Day 1 - day of study tracer administration
次要结局
- Discrimination of probable Alzheimer's Disease patients from healthy volunteers by BAY1006578 brain Positron Emission Tomography (PET) imaging as evaluated by visual analysis and by standard parameters (e.g. Standardized Uptake Values=SUV)(Day 1 - day of study tracer administration)
- Electrocardiogram (ECG)(At least once within 8 days after treatment)
- Blood pressure(At least 2 times within 8 days after treatment)
- Adverse events collection(Continuously and for a maximum of 28 days after end of observation phase)
研究者
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