ACTRN12619000467134尚未招募1 期
An Open-Label, Brain Imaging Study Using Positron Emission Tomography with 18F-FDG and MRI with Arterial Spin Labeling to Determine Changes in Brain Glucose Metabolism and Cerebral Blood Flow after Single-Dose Intravenous Administration of CST-101 in Healthy Subjects and Patients with Mild Cognitive Impairment
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 75 Years（—）
- 性别
- All
入选标准
- •Healthy subject volunteers must meet the following:
- •- Male aged 18-70 years
- •- Free from clinical significantly illness or disease
- •- No current use of any prescription medications, over-the-counter medications or nutritional supplements.
- •MCI patients must meet the following:
- •- Male or female aged 50-75 years
- •- Women of child-bearing potential must agree to effective methods of birth control
- •- Meet the criteria for amnestic MCI, as per the National Institute on Aging-Alzheimer's Association core clinical criteria
- •- Mini-Mental Status Exam (MMSE) Score greater than or equal to 26
排除标准
- •All subjects must not meet the following:
- •- History of any clinically significant disease or illness
- •- Clinically significant laboratory or ECG abnormality.
- •- Positive screening test for human immunodeficiency virus (HIV).
- •- Positive screening test for hepatitis C antibody (HCV Ab) or current hepatitis B infection.
- •- History of drug or alcohol abuse >12 months prior to Screening.
- •- History of nicotine use >6 months.
- •- A positive test for drugs of abuse or alcohol
- •- Contraindications for MRI and/or PET scans.
- •Other exclusion criteria may apply.
研究者
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