NCT01138111已完成1 期
ß-amyloid Imaging With BAY94-9172 Positron Emission Tomography for Early Detection of Alzheimer's Disease in Patients With Mild Cognitive Impairment
Life Molecular Imaging SA0 个研究点目标入组 45 人开始时间: 2008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
- 45
- 主要终点
- Quantitative Assessment of Neocortical SUVRs (Mean Standard Uptake Value Ratios) as a Measure of Florbetaben Uptake
研究概览
简要总结
The aim of the study is to investigate whether Florbetaben (BAY94-9172)positron emission tomography (PET) is able to distinguish between subjects with mild cognitive impairment (MCI) progressing to Alzheimer's disease (AD) from those with MCI not progressing to AD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of MCI defined as abnormal cognition on objective testing in the absence of dementia or significant functional loss.
- •Absence of systemic or other neurological disease that may contribute to cognitive impairment or prevent follow-up over two years.
- •Able to give written informed consent.
- •Age >/= 60 years of age
- •>/= 7 years of education
排除标准
- •Mini mental state examination (MMSE) score < 24 at baseline
- •Clinical dementia rating (CDR) score > 0.5 at baseline
- •Patients who receive regular medication of drugs which may adversely impact cognition (e.g. tricyclic antidepressants, antipsychotics and/or large doses of hypnotics or anxiolytics)
- •Existing or history of cancer
- •History of severe head trauma, brain surgery or intracranial hematoma with permanent brain lesion
- •Lifetime history of major affective disorder, schizophrenia, or schizo-affective disorder
- •Contraindications to MRI (Magnetic resonance imaging)
- •Relevant history, physical or imaging findings of neurological disease other than MCI and mild depression
- •History of severe anaphylactic reaction or high risk of allergic reaction to drugs
- •Patient has received another investigational drug in the preceding 14 days
研究组 & 干预措施
Arm 1
Experimental
干预措施: Florbetaben (BAY94-9172) (Drug)
结局指标
主要结局
Quantitative Assessment of Neocortical SUVRs (Mean Standard Uptake Value Ratios) as a Measure of Florbetaben Uptake
时间窗: 1 scanning period post injection to be evaluated at baseline, 12 months and 24 months
Mean SUVRs were calculated for subjects who did and did not progress to Alzheimer's Disease (AD) during the study for each PET scan time point (baseline, 12 and 24 months)
次要结局
- Sensitivity/Specificity/Negative Predictive Value (NPV)/Positive Predictive Value (PPV) at Baseline, 12, and 24 Months in the Detection of Significant Brain ß-amyloid Plaque Load in Patients With MCI Progressing to AD Compared to Those Who do Not Progress(2 scanning periods post injection to be evaluated at baseline)
- Number of Normal and Abnormal Scans in Patients With MCI Progressing to AD and Those Who do Not Progress Based on a Threshold of Neocortical SUVR=1.4(1 scanning period post injection to be evaluated at baseline, at 12 months and at 24 months)
- Number and Proportion of Normal and Abnormal Scans Based on Brain ß-amyloid Plaque Load (BAPL) in Subjects With MCI Converting to AD and Those Who do Not Progress(2 scanning periods post injection to be evaluated each at baseline, at 12 months, and at 24 months)
研究者
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