Prevention of Alzheimer's Disease in Women: Risks and Benefits of Hormone Therapy -Continuation of: "The Kronos Early Estrogen Prevention Study (KEEPS)"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 299
- 试验地点
- 6
- 主要终点
- AV-1451
研究概览
简要总结
The purpose of this study is to investigate how blood flow to the brain affects cognition in women who are postmenopausal, and how the use of hormone therapy early in menopause might change brain function. The testing in this study will add to the knowledge about brain aging in women. Researchers will determine if blood flow to the brain, brain structure, and cognition differences among women who took hormones in the past as part of Kronos Early Estrogen Prevention Study (KEEPS; NCT00154180), are currently taking hormones, or never took menopausal hormones.
详细描述
This is a continuation of the Kronos Early Estrogen Prevention Study (KEEPS) (KEEPS; NCT00154180), a multicenter double blinded, placebo-controlled, randomized trial funded by the Kronos Longevity Research Institute, Phoenix, AZ to test the hypothesis that hormone therapy started early in menopause (within the "window of opportunity") would slow progression of atherosclerosis as measured by changes in carotid artery intima-medial thickening and coronary arterial calcification.
This study will involve a single follow-up evaluation of brain imaging and cognitive function of women who were randomized to menopausal hormone therapy (mHT) or placebo, approximately 13 years post-randomization and nine years after the end of mHT administration phase in KEEPS (NCT00154180). No interventions are given as part of this study; any current hormonal treatments are by choice and prescribed by the participant's personal physician.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 49 Years 至 72 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Participated in the original KEEPS trial.
- •Able to understand study procedures.
- •Willing to sign an authorization of consent in order to participate in this study.
排除标准
- •Women who have contraindications to MRI or PET for safety reasons, such as an MRI-incompatible implant or claustrophobia.
结局指标
主要结局
AV-1451
时间窗: 4 years
This measure is derived from a PET imaging study that images the deposition of the tau protein of Alzheimer's disease in the brain
WMH volume
时间窗: 4 years
This measure is derived from an MRI study that images the brain structure. WMH is measured from specific regions of the brain that are vulnerable to cerebrovascular disease related injury.
Global cognitive function
时间窗: 4 years
This measurement is derived from multiple neuropsychometric tests that measure various cognitive abilities.
Aβ PET SUVR
时间窗: 4 years
This measure is derived from a PET imaging study that images the deposition of the amyloid plaques of Alzheimer's disease in the brain
Regional cortical thickness
时间窗: 4 years
This measure is derived from an MRI study that images the brain structure. The cortical thickness is measured from specific regions of the brain that are vulnerable to Alzheimer's disease related neurodegeneration.
次要结局
未报告次要终点
研究者
Kejal Kantarci
Professor of Radiology, Cons-Research Neuroradiology
Mayo Clinic