Vascular Mechanisms for the Effects of Loss of Ovarian Hormone Function on Cognition in Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Changes in Prefrontal Cortex Brain Activation at 9 Months
研究概览
简要总结
Complaints about memory and thinking are common in women as they go through menopause and estrogen levels fall. The ovarian hormone estrogen is important for supporting normal cognitive function, and changes in brain activity and function occur when estrogen levels are decreased. Estrogen is also important for maintaining healthy blood vessels which also support normal cognitive function. In Alzheimer's disease and other types of dementia, there is significant damage to the blood vessels in the brain. This study will test whether changes in brain activity and function with the loss of estrogen are related to changes in vascular function. The investigators will measure vascular function using ultrasound, and brain activity using MRI scans in women who are enrolled in the Females, Aging, Metabolism and Exercise (FAME) study (NCT01712230). In the FAME study, healthy premenopausal women either take a medication to decrease their estrogen levels, or a placebo. This sub-study may provide new information about how estrogen affects vascular function and cognitive function, and lead to new ways to prevent or delay cognitive impairment or dementia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Volunteers will be healthy women aged 40 to 60 years
- •Are enrolled in the parent FAME study (NCT01712230).
- •The Investigators will consent up to 80 subjects with the aim of enrolling 17 in each of the 2 groups (placebo, GnRH agonist).
排除标准
- •mini-mental state examination (MMSE) score 27 or less
- •history of neurologic disease or major psychiatric illness
- •major depressive episode within the past 12 months
- •history of learning disability
- •less than high-school education
- •current smoking
- •use of psychoactive medications in the past 3 months (stable use of anti- depressant medication is allowed)
- •contraindications to MRI scanning
研究组 & 干预措施
Placebo
Monthly placebo injections for 6 months under parent study (FAME) protocol (NCT01712230)
干预措施: Placebo (Drug)
GnRH agonist
Monthly injections of leuprolide acetate 3.75mg for 9 months; first 6 months under parent study (FAME) protocol (NCT01712230); months 6-9 under sub-study protocol.
Weekly application of estradiol patch 0.075mg/d months 6-9.
Daily medroxyprogesterone acetate 5mg by mouth for 12 days at week 30.
干预措施: Leuprolide acetate (Drug)
GnRH agonist
Monthly injections of leuprolide acetate 3.75mg for 9 months; first 6 months under parent study (FAME) protocol (NCT01712230); months 6-9 under sub-study protocol.
Weekly application of estradiol patch 0.075mg/d months 6-9.
Daily medroxyprogesterone acetate 5mg by mouth for 12 days at week 30.
干预措施: Estradiol (Drug)
GnRH agonist
Monthly injections of leuprolide acetate 3.75mg for 9 months; first 6 months under parent study (FAME) protocol (NCT01712230); months 6-9 under sub-study protocol.
Weekly application of estradiol patch 0.075mg/d months 6-9.
Daily medroxyprogesterone acetate 5mg by mouth for 12 days at week 30.
干预措施: Medroxyprogesterone (Drug)
结局指标
主要结局
Changes in Prefrontal Cortex Brain Activation at 9 Months
时间窗: Baseline, 9 months
Changes in patterns of brain activation in the prefrontal cortex using functional magnetic resonance imaging (fMRI) during a task of working memory will be measured at baseline, 6 months, and 9 months (GnRH agonist arm only). Beta weight is the percent signal change on the FMRI from one condition to another. The FMRI is measuring blood oxygen levels and blood flow in different regions of the brain and using that to determine activity changes in the brain. A positive number/increase indicates more blood flow and brain activity in that area.
Changes in Prefrontal Cortex Brain Activation at 6 Months
时间窗: Baseline, 6 months
Changes in patterns of brain activation in the prefrontal cortex using functional magnetic resonance imaging (fMRI) during a task of working memory will be measured at baseline, 6 months, and 9 months (GnRH agonist arm only). Beta weight is the percent signal change on the FMRI from one condition to another. The FMRI is measuring blood oxygen levels and blood flow in different regions of the brain and using that to determine activity changes in the brain. A positive number/increase indicates more blood flow and brain activity in that area.
次要结局
- Changes in Endothelial Function at 9 Months(Baseline, 9 months)
- Changes in Artery Compliance at 6 Months(Baseline, 6 months)
- Changes in Executive Cognitive Function: Stroop, 6 Months(Baseline, 6 months)
- Changes in Endothelial Function at 6 Months(Baseline, 6 months)
- Changes in Executive Cognitive Function: Digits, 9 Months(Baseline, 9 months)
- Changes in Executive Cognitive Function: Trails A, 6 Months(Baseline, 6 months)
- Changes in Executive Cognitive Function: RAVLT, 6 Months(Baseline, 6 months)
- Changes in Executive Cognitive Function: RAVLT, 9 Months(Baseline, 9 months)
- Changes in Executive Cognitive Function: Trails B, 9 Months(Baseline, 9 months)
- Changes in Artery Compliance at 9 Months(Baseline, 9 months)
- Changes in Executive Cognitive Function: Trails B, 6 Months(Baseline, 6 months)
- Changes in Executive Cognitive Function: Trails A, 9 Months(Baseline, 9 months)
- Changes in Executive Cognitive Function: Digits Span Forward and Backward, 6 Months(Baseline, 6 months)
- Changes in Executive Cognitive Function: Controlled Oral Word Association Test, 9 Months(Baseline, 9 months)
- Changes in Executive Cognitive Function: Stroop, 9 Months(Baseline, 9 months)
- Changes in Executive Cognitive Function: Controlled Oral Word Association Test, 6 Months(Baseline, 6 months)