Sex-Specific Effects of Endocrine Disruption on Aging and Alzheimer's Disease
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 614
- 试验地点
- 1
- 主要终点
- 18F-Flortaucipir PET imaging
研究概览
简要总结
The researchers are trying to determine whether ovarian hormones are associated with aging processes and with the risk of developing Alzheimer's disease in women.
详细描述
The proposed project will enroll a total of 614 women.
Mayo Clinic Rochester Participants: Each women will have 2-3 clinic visits consisting of cognitive testing, tests of physical function, questionnaires, and a blood draw. All women will also undergo clinical neuroimaging, which includes structural MRI, β-amyloid (Aβ) deposition on PET as a biomarker of Aβ pathology, and tau deposition on PET as a marker of neurofibrillary tangles using AV-1451. All participants will have previously participated and will return by invitation only.
Mayo Clinic Jacksonville Participant: Only African American Women will be enrolled at this site. Each women will have 1-3 clinic visits consisting of physical function testing and neuroimaging, which includes structural MRI, β-amyloid (Aβ) deposition on PET as a biomarker of Aβ pathology, and tau deposition on PET as a marker of neurofibrillary tangles using AV-1451.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women who previously participated in this study
- •Currently aged 60 years and older
- •More than six months post chemotherapy or major surgery requiring general anesthesia
- •Willing and able to sign informed consent
排除标准
- •Not able to read and speak English
- •In hospice
- •Claustrophobic
- •If undergoing Tau imaging, cannot have QT Prolongation
- •Mayo Clinic Jacksonville-
- •Inclusion Criteria:
- •African American Women
- •Currently aged 60 years and older
- •More than six months post chemotherapy or major surgery requiring general anesthesia
- •Willing and able to sign informed consent
- •Exclusion Criteria:
- •Not able to read and speak English
- •In hospice
- •Claustrophobic
- •If undergoing Tau imaging, cannot have QT Prolongation
研究组 & 干预措施
Women
18F-Flortaucipir and 11C-Pittsburgh compound-B radioligands will be used for experimental PET imaging of beta-amyloid and neurofibrillary tau pathology
干预措施: 18-F-Flortaucipir (Drug)
结局指标
主要结局
18F-Flortaucipir PET imaging
时间窗: 1 day
Cortical 18F-Flortaucipir PET imaging measured once in each participant
Pittsburgh compound-B PET imaging
时间窗: 1 day
Global cortical SUVR measured once in each participant
次要结局
未报告次要终点
研究者
Kejal Kantarci
Principal Investigator
Mayo Clinic