Hormones and Cognitive Processing in Early Postmenopausal Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Changes in Brain Activation Patterns in Visual Tasks Determined With the Functional Magnetic Resonance Imaging (fMRI) Scans
研究概览
简要总结
The objective of this study is to evaluate the neurobiological effects of hormone therapy (HT) in healthy early postmenopausal women. The studies proposed in this project seek to define the association between different hormone forms (estradiol only and progesterone only) versus placebo on brain functional measures. The functional measures will include the performance of the volunteers on a comprehensive neuropsychological testing battery, and the brain functional responses to episodic memory (verbal and non-verbal) challenges as well as emotional processing determined with functional magnetic resonance imaging (fMRI).
详细描述
Specific Aims
Aim 1. To examine the effects of estradiol alone on brain functioning in early post-menopausal women during verbal and non-verbal cognitive tasks.
Hypothesis: It is expected that with estradiol treatment brain activation will be more prominent in the hippocampus and prefrontal cortical areas compared to placebo. The magnitude of activation in these regions will be positively correlated with task performance in the scanner and with the results of neuropsychological tests assessing verbal and non-verbal delayed recall.
Aim 2. To determine the effects of progesterone alone on brain functioning in early postmenopausal women during verbal and non-verbal cognitive tasks.
Hypothesis: It is expected that with progesterone treatment brain activation in the hippocampus and prefrontal cortical areas will be decreased compared to both the placebo condition (within subjects) and the estradiol condition (between subjects). Interindividual variations in the magnitude of activation in these regions will be positively correlated with task performance in the scanner and with the results of neuropsychological tests assessing verbal and non-verbal delayed recall.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Postmenopausal women
- •Ages 45-55, 6 - 36 months from their last menstrual period.
排除标准
- •Left handedness
- •Acute medical illness
- •Neurologic illness
- •Psychiatric illness
- •Heart disease
- •Thromboembolic disease
- •Liver disease
- •Uncorrected thyroid disease
- •Neurological disease
- •Porphyria
- •Allergy to estradiol
- •Progesterone or lactose
- •Lactose intolerance
- •Claustrophobia
- •Contraindications to MRI (including pacemakers, surgical clips or metallic surgical devices)
- •Smoking within the last 3 years
- •Use of hormones within the last 3 months
- •Current or past history of substance abuse
- •History of head injury or loss of consciousness
- •Medications with actions on the central nervous system
- •Endometrial lining greater than 5mm
- •Ovarian pathology on ultrasound
- •Abnormal mammogram
- •Migraines
- •Fasting cholesterol >300 mg/dl, and fasting triglycerides >300 mg/dl
- •Creatinine level > 1.5 mg/dl
- •Aspartate transaminase (AST) or Alanine transaminase (ALT) greater than two times the top normal range
- •Follicle stimulating hormone (FSH) values <40 IU/L
- •estradiol >40 pg/ml.
- •Subjects with HAM-D score > 8, HAM-A > 6 during screening will not be eligible.
研究组 & 干预措施
Estrogen followed by Placebo
Estrogen treatment with Estradiol (E2) followed by Placebo.
干预措施: Estradiol (E2) (Drug)
Estrogen followed by Placebo
Estrogen treatment with Estradiol (E2) followed by Placebo.
干预措施: Progesterone (P10) x10 (Drug)
Progesterone followed by Placebo
Progesterone (P10) treatment followed by Placebo.
干预措施: Progesterone (P10) x90 (Drug)
Placebo followed by Estrogen
Placebo followed by Estrogen treatment with Estradiol (E2)
干预措施: Estradiol (E2) (Drug)
Placebo followed by Estrogen
Placebo followed by Estrogen treatment with Estradiol (E2)
干预措施: Progesterone (P10) x10 (Drug)
Placebo followed by Progesterone
Placebo followed by Progesterone (P10) treatment.
干预措施: Progesterone (P10) x90 (Drug)
结局指标
主要结局
Changes in Brain Activation Patterns in Visual Tasks Determined With the Functional Magnetic Resonance Imaging (fMRI) Scans
时间窗: August 2010 - March 2012
Measure the changes in brain activity in visual tasks with hormone use (either estradiol or progesterone) versus placebo. The test is a visual working memory task, where the women are presented with 3 geometric grids on the screen. The target grid is on top, and 2 test grids are on the bottom. The women must decide if the right or left test grid matches the grid on top. There are 3 conditions: a match condition where all 3 grids are shown simultaneously, and 2 delay conditions, where the target grid is shown first, disappears, and the test grids appear after a 1 or a 4 second delay. The test was administered 3 months after baseline and 38 weeks after baseline.
Changes in Brain Activation Patterns in Verbal Tasks Determined With the Functional Magnetic Resonance Imaging (fMRI) Scans
时间窗: August 2010 - March 2012
Measure the changes in brain activity in verbal tasks with hormone use (either estradiol or progesterone) versus placebo. The test is a deep and shallow verbal processing task, where the subjects are presented lists of words, one word at a time, and are asked to make one of 2 decisions about each list. One decision is whether each word is written in upper or lower case letters (shallow processing), and the other decision is whether each word denotes an abstract or concrete concept (deep processing). The test was administered 3 months after baseline and 38 weeks after baseline.
次要结局
- Neuropsychological Testing Scores - Visual Learning Retention(August 2010 - March 2012)
- Neuropsychological Testing Scores - Verbal Learning Retention(August 2010 - March 2012)
研究者
Yolanda Smith, M.D.
Professor
University of Michigan