Open Label Positron Emission Tomography (PET) Study With [11C]AZD2995 and [11C]AZD2184, Candidate PET Ligands for β 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
- 13
- 试验地点
- 1
- 主要终点
- Positron emission tomography using the radioligand (11C)AZD2995 or (11C)AZD2184
研究概览
简要总结
The study is carried out in order to investigate if [11C]AZD2995, compared to [11C]AZD2184, is a more suitable PET ligand for in vivo imaging of β 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.
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
- 20 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, clinical progression of AD over 12 months.
- •Healthy male volunteers: - Age 20-50 years, Body Mass Index: 18-30 kg/m
- •Clinically normal physical findings including normal blood pressure and pulse rate.
排除标准
- •Alzheimer´s Disease patients:
- •significant cerebrovascular disease or depression, central nervous system infarct or infection or lesions
- •clinically significant illness within 2 weeks before the study start.
- •administration of any investigational product with effect on brain beta amyloid levels within 3 months prior to study and/or participation in a PET investigation other than study D0180C00011 as part of a scientific study during the past 12 months,.
- •Healthy volunteers; - clinically significant illness within 2 weeks before the study start, 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
Alzheimer's Disease (AD) patients
干预措施: Radioligand (11C)AZD2995 (Drug)
1
Alzheimer's Disease (AD) patients
干预措施: Radioligand (11C)AZD2184 (Drug)
2
Healthy volunteers
干预措施: Radioligand (11C)AZD2995 (Drug)
2
Healthy volunteers
干预措施: Radioligand (11C)AZD2184 (Drug)
结局指标
主要结局
Positron emission tomography using the radioligand (11C)AZD2995 or (11C)AZD2184
时间窗: Radioligand (11C)AZD2995.1-2 PET examinations for AD patients and 1 PET examination for healthy volunteers. - Radioligand (11C) AZD2184.One PET for AD patients respective healthy volunteers.
次要结局
- To assess safety and tolerability of [11C]AZD2995, [11C]AZD2184 and the study procedures, by assessment of adverse events, vital signs and laboratory variables.(3-4 visits with tests for the AD patients. 3 visits with tests for the healthy volunteers. All tests are not done at every visit.)