Hormone Replacement Trial Against ALzheimers' Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- identify BACE1 in blood
研究概览
简要总结
The influence of postmenopausal hormone treatment on dementia is not clear. Dysfunctions in the metabolism of amyloid in the disease of Alzheimer result in an elevated presence of degradation products in cerebrospinal fluid.
The degradation products in blood will be analysed during the trial, to get better insight in menopause and the start of hormonal therapy.
Postmenopausal women with and without history of breast cancer will be recruited for the trial.
详细描述
The influence of postmenopausal hormone treatment on dementia is not clear. Recently an overview was published.
Dysfunctions in the metabolism of amyloid in the disease of Alzheimer result in an elevated presence of degradation products in cerebrospinal fluid. There are tests developed to detect those degradation products in blood.
The degradation products in blood will be analysed during the trial, to get better insight in menopause and the start of hormonal therapy. The participants will be asked to come 2 times to the hospital. At every study visit, blood will be taken and questionnaires will be completed. The first study visit will take place before the start of the hormonal treatment, the second visit will take place 6 months after the start of the hormonal treatment.
There will be 30 patients included per study group. There are 10 groups in total:
- Postmenopausal women who start oral hormonal treatment
- Postmenopausal women who start transdermal hormonal treatment
- Postmenopausal women who start oral hormonal treatment and had a hysterectomy in their medical history
- Postmenopausal women who start transdermal hormonal treatment and had a hysterectomy in their medical history
- Postmenopausal women who start oral hormonal treatment and have an intra-uterine device
- Postmenopausal women who start transdermal hormonal treatment and have an intra-uterine device
- Postmenopausal women with breast cancer taking selective oestrogen receptor modulators
- Postmenopausal women with breast cancer taking aromatase inhibitors
- Postmenopausal women with breast cancer taking duavive
- Postmenopausal women with no breast cancer and do not start with hormonal therapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •postmenopausal women
- •40 - 65 years
排除标准
- •Longer than 10 years in menopause
- •thyroid dysfunction
- •hypertension
- •medical history of psychiatric comorbidity
- •Alcohol and/or drug abuse
- •medical history of neurologic symptoms with cognitive symptoms
结局指标
主要结局
identify BACE1 in blood
时间窗: 2 years after the first patient was included, the first batch of samples will be analysed.
The influence of hormone treatment (menopause) and anti-hormone treatment (breastcancer) on the amyloid metabolism and the development of Alzheimer will be evaluated. BACE1 will also be identified in the blood.
APOE-genotyping in blood
时间窗: 2 years after the first patient was included, the first batch of samples will be analysed.
The influence of hormone treatment (menopause) and anti-hormone treatment (breastcancer) on the amyloid metabolism and the development of Alzheimer will be evaluated. APOE-genotyping will be performed
Degradation products of the Amyloid metabolism in blood
时间窗: 2 years after the first patient was included, the first batch of samples will be analysed.
The influence of hormone treatment (menopause) and anti-hormone treatment (breastcancer) on the amyloid metabolism and the development of Alzheimer will be evaluated. Different laboratory analysis will be performed to evaluate the degradation products of the metabolism of amyloid in blood. Different parts of the degradation products will be analysed namely: Plasma total-tau
次要结局
未报告次要终点