NCT00870519终止1 期
Evaluation of [123I] MNI-168 and SPECT as a Marker of Beta-amyloid Protein Deposition in Subjects With Alzheimer Disease in Comparison to Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- To assess the uptake and washout of {I123}MNI-168, a potential imaging biomarker for β-amyloid burden in brain,
研究概览
简要总结
The underlying goal of this study is to assess 123-I MNI-168 SPECT imaging as a tool to detect ß-amyloid deposition in the brain of Alzheimer's Disease (AD) research participants and similarly aged and gender matched healthy subjects.
详细描述
The overall research questions to be addressed by this protocol are as follows:
- To assess the dynamic uptake and washout of (123I) MNI-168, a potential imaging biomarker for β-amyloid burden in brain, using single photon emission computed tomography (SPECT) in Alzheimer's (AD) subjects and similarly aged and gender matched healthy controls.
- To perform blood metabolite characterization of (123I) MNI-168 in healthy and AD subjects to determine the metabolic fate and nature of metabolites in assessment of (123I) MNI-168 as a single photon computed tomography (SPECT) brain imaging agent.
- To acquire initial safety data following injection of (123I) MNI-168.
- Obtain test/retest reproducibility information in AD subjects with (123I) MNI-168 based on initial studies.
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
- •Subjects who have a clinical diagnosis of AD will be recruited for this study
- •The participant is 50 years or older
- •Written informed consent is obtained
- •Participants have a clinical diagnosis of probable Alzheimer's disease based on National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria
- •Subjects will have a clinical dementia rating (CDR) assessment score of ≥ 0.5 and < 2.0
- •Modified Hachinski Ischemia Scale score of ≤ 4
- •For females, non-child bearing potential or negative urine and blood pregnancy test on day of 123-I MNI-168 injection
排除标准
- •The subject has signs or symptoms of another neurodegenerative disease including Parkinson's disease, diffuse Lewy body dementia, or history of significant cerebrovascular disease
- •The subject has clinically significant abnormal laboratory value and/or clinically significant unstable medical or psychiatric illness
- •The subject has any disorder that may interfere with drug absorption distribution, metabolism, or excretion (including gastrointestinal surgery)
- •The subject has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency, pulmonary, or other disorder or disease
- •The subject has participated in another clinical study within the previous 30 days
- •Clinically significant MRI evidence of vascular disease or alternative neurologic disorder
- •Pregnancy
研究组 & 干预措施
I 123-MNI-168
Experimental
干预措施: I-123-MNI-168 (Drug)
I 123-MNI-168
Experimental
干预措施: 123-I MNI-168 (Drug)
I123 MNI168
Experimental
brain imaging using I123MNI168
干预措施: I-123-MNI-168 (Drug)
I123 MNI168
Experimental
brain imaging using I123MNI168
干预措施: 123-I MNI-168 (Drug)
结局指标
主要结局
To assess the uptake and washout of {I123}MNI-168, a potential imaging biomarker for β-amyloid burden in brain,
时间窗: 1 year
次要结局
- To acquire initial safety data following injection of (123I) MNI-168.(1 year)
研究者
研究点 (1)
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