Open Label Positron Emission Tomography Study With [18F]AZD4694 and [11C]AZD2184, Candidate Radioligands for AB Amyloid, to Determine and Compare in Vivo Brain Uptake and Distribution in Healthy Volunteers and Patients With Alzheimer's Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Positron emission tomography using the radioligand [18F]AZD4694 and/or [11C]AZD2184
研究概览
简要总结
The study is carried out in order to investigate if [18F]AZD4694, compared to [11C]AZD2184, is a suitable PET ligand for in vivo imaging of Aβ amyloid depositions in the human brain. In the study the two PET ligands will be examined in both healthy volunteers and patients with Alzheimer's Disease. A whole body dosimetry scanning will be performed in 6 healthy volunteers to obtain human data to estimate a safe dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Alzheimer's Disease patients - 50-85 years, mild to moderate AD: MMSE ≥16 and ≤ 26, clinical progression of AD over 12 months.
- •Healthy volunteers: - 50-75 years
- •BMI 18 and 30 m2/kg
- •Clinically normal physical findings including supine blood pressure and pulse rate.
排除标准
- •Alzheimer's Disease patients - Clinically significant illness the 2 weeks prior to the administration of the PET ligand
- •Significant cerebrovascular disease or depression, central nervous system infarct or infection or lesions
- •Administration of any investigational product within 3 months prior to study and/or PET measurements for scientific purposes within the last 12 months.
- •Healthy volunteers - clinically significant illness within 2 weeks before administration of PET ligand, history of psychiatric or somatic disease/condition that may interfere, first degree relative with dementia. Obvious deterioration of memory functions.
研究组 & 干预措施
1
干预措施: radioligand [18F]AZD4694 (Drug)
1
干预措施: radioligand [11C]AZD2184 (Drug)
结局指标
主要结局
Positron emission tomography using the radioligand [18F]AZD4694 and/or [11C]AZD2184
时间窗: Radioligand [18F]AZD4694: 1-2 PET examinations for AD patients and 1 PET examination for healthy volunteers. Whole body dosimetri for some healthy volunteers. - Radioligand [11C]AZD2184: 1 PET for AD patients respective healthy volunteers.
次要结局
- To assess safety and tolerability of [18F]AZD4694 and the study procedures, by assessment of adverse events, vital signs, and laboratory variables.(3-4 visits with tests for AD patients respective healthy volunteers. All tests are not done at every visit.)