Alzheimer's Disease: Therapeutic Potential of Estrogen
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Cognition: delayed recall on Buschke Selective Reminding Test; Stroop Interference condition--completion time and errors; Clinician-rated Interview Based Impression of Change
研究概览
简要总结
This is a 15-month study to determine the effectiveness of hormone replacement therapy in improving memory and the ability to live independently in postmenopausal women with Alzheimer's disease.
详细描述
Estrogen is a naturally occurring hormone produced in a woman's body. The purpose of this 15-month study is to determine the effectiveness of hormone replacement therapy in improving memory and the ability to live independently in postmenopausal women with Alzheimer's disease and without other dementias.
Patients who volunteer for this study will either receive a patch containing 17-ß-estradiol or will receive an inactive placebo patch. In addition, patients will be given either medroxyprogesterone or an inactive placebo pill. Neither the volunteers nor the study staff will know which type of patch or pill a patient receives. Patients must be generally healthy and have mild-to-moderate dementia. There must be a patient caregiver who can watch for side effects and ensure that the patient takes the study medications on schedule. Patients will undergo neuropsychological tests and an evaluation of the ability to live independently at each visit as well as laboratory evaluations, such as the taking of blood. Each visit will last approximately 3 hours. A total of 160 participants are being recruited.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women with Alzheimer's disease and without other dementias (diagnosed by study staff or from an outside clinic)
- •Mini Mental State Examination score greater than 15/30
排除标准
- •History of cancer of reproductive tissues
- •History of deep vein thrombosis or blot clots
- •Heart disease or stroke
- •Liver problems including hepatitis
- •Severe vision or hearing problems
- •Tobacco use
- •Lack of an adequate caregiver
- •inability to perform psychometric testing
研究组 & 干预措施
1
estradiol patch and medroxyprogesterone
干预措施: Transdermal estradiol (Drug)
1
estradiol patch and medroxyprogesterone
干预措施: Medroxyprogesterone (Drug)
2
estradiol patch and placebo pill
干预措施: Transdermal estradiol (Drug)
2
estradiol patch and placebo pill
干预措施: Placebo (Drug)
3
placebo patch and medroxyprogesterone
干预措施: Medroxyprogesterone (Drug)
3
placebo patch and medroxyprogesterone
干预措施: Placebo Patch (Drug)
4
placebo patch and placebo pill
干预措施: Placebo Patch (Drug)
4
placebo patch and placebo pill
干预措施: Placebo (Drug)
结局指标
主要结局
Cognition: delayed recall on Buschke Selective Reminding Test; Stroop Interference condition--completion time and errors; Clinician-rated Interview Based Impression of Change
时间窗: Baseline and 1, 3, 6, 12, and 15 months
次要结局
- Skills of Independent Living: Physical functioning Performance (PFP)(Baseline and 1, 3, 6, 12, and 15 months)
- Bioassays (Estradiol, estrone, medroxyprogesterone, FSH, influence of ApoE genotype in responsivity to estrogen)(Baseline and 1, 3, 6, 12, and 15 months)