Clinical Evaluation of Florbetapir F 18 (18F-AV-45) / Determinants of Neurodegenerative Decline in Primary Progressive Aphasia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Detecting amyloid burden in subjects with neurodegenerative diseases
研究概览
简要总结
The purpose of this research is to better understand how dementia affects activity in different parts of the brain.
详细描述
This study is being done to examine the usefulness of Positron Emission Tomography (PET) imaging with florbetapir F 18 as a biomarker in the identification of amyloid-ß peptide (Aß) in the brain. Amyloid-ß peptide (Aß) accumulates in the brains of patients with Alzheimer's disease. Florbetapir F 18 sticks to the amyloid plaques in the brain and emits a low level of gamma rays which can be detected by a PET camera. The development of biomarker and imaging studies that track the development of PPA and reflect the change in people's bodies may help other people who have a similar medical problem in the future.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who, in the opinion of the investigator, can tolerate the PET scan procedures
排除标准
- •Clinically significant cardiovascular disease
- •clinically significant hepatic, renal, pulmonary, metabolic, or endocrine disturbances
- •Breastfeeding
- •Women of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception.
- •History of relevant severe drug allergy or hypersensitivity
- •Patients who have received an investigational medication under an FDA Investigational New Drug (IND) protocol within the last 30 days.
研究组 & 干预措施
Florbetapir F 18 Recipients
Participants in this arm of the study will receive a 10 mCi (370 MBq) bolus injection of florbetapir F 18 and then be scanned in a PET scanner for brain imaging.
干预措施: Florbetapir F 18 (Drug)
Florbetapir F 18 Recipients
Participants in this arm of the study will receive a 10 mCi (370 MBq) bolus injection of florbetapir F 18 and then be scanned in a PET scanner for brain imaging.
干预措施: Positron Emission Tomography (Device)
结局指标
主要结局
Detecting amyloid burden in subjects with neurodegenerative diseases
时间窗: 4 years
The study will provide standardized conditions for florbetapir F 18 use, amyloid binding as measured by PET imaging, and long-term outcome in cognitively normal volunteers, patients with Alzheimer's Disease, patients with Mild Cognitive Impairment, and patients with other neurodegenerative diseases. It will also facilitate evaluation of subject's amyloid burden in companion studies such as longitudinal studies of aging, studies of progressive cognitive impairment, and studies of imaging and blood/cerebrospinal fluid biomarkers of neurodegenerative disease.
次要结局
未报告次要终点
研究者
Emily Rogalski
Principal Investigator
Northwestern University