IRCT20200711048075N1尚未招募3 期
The effect of Hydralazine on early stage of Alzheimer’s disease: A randomized clinical trial
ational Institute for Medical Research Development0 个研究点目标入组 424 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 424
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 49 years 至 no limit（—）
- 性别
- All
入选标准
- •Diagnoses of possible or probable Alzheimer's disease (NINCDS-ADRDA).
- •Presence of a caregiver (friend or relative) who can assume responsibility for medication administrations, accompany the patient to all visits, and rate patient's condition.
- •Written informed consent from both the patient (or surrogate) and caregiver.
- •An MMSE score between 12 and 26 inclusive.
- •Administration of a maintenance dosage of donepezil (5-10mg/d), rivastigmine (3-6mg/d), galantamine or galantamine ER (8-16mg/d) for a minimum of 4 weeks prior to randomization.
- •Agreement not to take Hydralazine.
- •Age 49 and over
排除标准
- •A non-Alzheimer primary dementia (e.g., vascular dementia, Lewy body dementia, frontotemporal dementia, vitamin B-12 deficiency, hypothyroidism).
- •Current major depression, delirium, alcohol or psychoactive substance abuse or dependency, schizophrenia, or delusional disorder as defined by DSM-IV.
- •Presence of any uncontrolled systemic illness that would interfere with participation in the study or a life expectancy of less than one year.
- •Currently being treated with Hydralazine or a history of intolerance to oral therapy with Hydralazine
- •Any intravenous treatment for heart failure, except IV furosemide (e.g. IV inotropes, pressors, nitrates or nesiritide) at the time of screening.
- •Systolic blood pressure <100 mmHg
- •Reversible etiology of acute heart failure such as myocarditis, acute myocardial infarction-over the past 4 weeks, arrhythmia and pacing device (Acute MI is defined as symptoms and major electrocardiogram (ECG) changes(i.e., ST segment elevations), and arrhythmia includes unstable heart rates above 120/min or below 50/min).
- •Known severe congenital heart disease (such as uncorrected tetralogy of fallot or transposition of the aorta) and severe aortic or mitral stenosis or severe rheumatic mitral regurgitation.
- •Concurrent use of phosphodiesterase type 5 (PDE5) inhibitors (e.g. Viagra, Sildenafil. Etc.)
- •Have had cardiac revascularisation within the last 3 months or are likely to require coronary revascularisation within the study period.
- •eGFR< 15ml/min/1.73m2, or on regular dialysis, or planned dialysis within the study period
研究者
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