KCT0002516招募中未知
Effect of hormone therapy combined with donepezil in women with mild cognitive impairment
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 162
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 50(Year) 至 85(Year)（—）
- 性别
- Female
入选标准
- •Age: 50-85 years old
- •- Postmenopausal women: natural or surgical
- •- A diagnosis of mild cognitive impairment (amnestic subtype) according to Peterson’s criteria
- •- MMSE score > (normal average – 1x standard deviation)
- •- In good physical ability which allows the patient to visit outpatient clinic with some assistance
排除标准
- •- An advanced, severe, progressive, or unstable disease of any type that may interfere with efficacy and safety assessments or put the patient at special risk
- •- Any medical or neurological condition that might cause dementia or cognitive impairment (e.g., abnormal thyroid function tests, vitamine B12 or folate deficiency, posttraumatic conditions, Huntington’s disease, Parkinson’s disease, multiple sclerosis, cerebral palsy, encephalitis, encephalomeningitis, syphilis)
- •- A current DSM-IV diagnosis of major depression, unless successfully treated with a stable dose of an antidepressant without anticholinergic properties for least 4 weeks
- •- Severe liver disease or impaired renal function severe enough to need a dialysis
- •- Past history of hospital admission due to psychosis or affective disorders for the past five years.
- •- Past history within the past five years of alcohol or other drug intoxication that had to be treated
- •- Past history of prolonged loss of consciousness more than one hour or serious head injury that needed to be admitted for treatment.
- •- A disability that may prevent the patient from completing all study requirements (e.g., blindness, deafness, sever language difficulty)
- •- Induced menopause with anti-cancer chemotherapy or radiation therapy
- •- Breast cancer
- •- Active thrombophlebitis (deep vein thrombosis, pulmonary thromboembolism)
- •- Undiagnosed vaginal bleeding
- •- Acute liver disease (GOT/GPT: above twice the upper limit of normal range)
- •- Allergy against the trial medicine
- •- Current or recent user (< 3 months) of HT
- •- Current or recent user (< 3 months) of donepezil
研究者
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