NCT01940952Unknown3 期
Efficacy of Zydena (Udenafil) on Cognitive Function of Alzheimer's Disease Patients: A Randomized, Double Blind, Placebo-controlled Multicenter Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Change in cognitive function
研究概览
简要总结
The purpose of this study is to determine whether Zydena (Udenafil) has positive effect on cognitive function in patients with Alzheimer's disease.
This study is a randomized, double blind, placebo-controlled multicenter study.
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
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent;
- •Male or female subjects 50 to 90 years of age;
- •Diagnosis of probable Alzheimer's disease according to National Institute of Neurological Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria;
- •A Mini-Mental State Examination (MMSE) score of ≥10 and ≤26;
- •Global Clinical Dementia Rating ≥ 0.5;
- •Mild to moderate (not severe) white matter hyperintensities on brain MRI performed within three years from screening;
- •Good enough hearing and visual function to complete neuropsychological tests
- •Caregivers living with patients or spending 10 or more hours a week with patients;
- •Stable dose of donepezil (5mg to 10mg) for at least 60 days;
- •If patients have been on memantine, it should be washed out for at least 60 days;
- •Medications including anxiolytics, antipsychotics, and hypnotics may be taken if the dose has been stable for at least two weeks
排除标准
- •History of stroke within 6 months;
- •Previous diagnosis of severe (more than 80%) intracranial artery stenosis;
- •History of heart failure, ischemic heart disease (myocardial infarction, unstable angina, and stable angina), hypertrophic cardiomyopathy, and life-threatening arrhythmia;
- •Previous history of coronary artery bypass graft surgery;
- •Severe symptom of orthostatic hypotension (orthostatic syncope or presyncope), especially when patients take alpha-adrenergic blocker (Alfuzosin, Doxazosin, Naftopidil, Tamsulosin, Terazosin, Arotinolol, Carvedilol, Labetalol, Trazodone, typical and atypical antipsychotics);
- •Uncontrolled diabetes mellitus;
- •Proliferative diabetic retinopathy;
- •Severe hypotension (blood pressure less than 90/50mmHg) or severe hypertension (blood pressure more than 170/100mmHg);
- •Hepatic dysfunction (AST or ALT more than three times of upper normal limit) or renal dysfunction (serum creatinine more than 2.5mg/dL);
- •Retinitis pigmentosa;
- •Previous history of active peptic ulceration within one year before screening;
- •Hematodyscrasia susceptible to priapism including sickle cell anemia, multiple myeloma, leukemia, and various bleeding disorders;
- •History of drug abuse;
- •Medication including nitrates/nitric oxide donor (ex: nitroglycerin, isosorbide mononitrate, isosorbide dinitrate, amyl nitrate/nitrite, and Sodium nitroprusside), androgen (ex: testosterone), anti-androgen, and anticoagulants;
- •Current cancer chemotherapy;
- •Usage of PDE5i (Zydena, Viagra®, Levitra®, or Cialis®) within two weeks before study start;
- •History of hypersensitive reaction to PDE5i (Zydena, Viagra®, Levitra®, or Cialis®)
研究组 & 干预措施
Zydena 50mg
Active Comparator
Zydena (Udenafil) 50mg + Donepezil 5mg or 10mg
干预措施: Zydena (Udenafil) 50mg + Donepezil 5mg or 10mg (Drug)
Placebo
Placebo Comparator
Placebo + Donepezil 5mg or 10mg
干预措施: Placebo + Donepezil 5mg or 10mg (Drug)
Zydena 100mg
Active Comparator
Zydena (Udenafil) 100mg + Donepezil 5mg or 10mg
干预措施: Zydena (Udenafil) 100mg + Donepezil 5mg or 10mg (Drug)
结局指标
主要结局
Change in cognitive function
时间窗: from baseline to Week 12 and Week 24 after the administration of the medication
measured by ADAS-cog
次要结局
- Change in cognitive function(from baseline to Week 12 and Week 24)
- Change in behavioral symptoms(from baseline to Week 12 and Week 24)
- Change in brain function(from baseline to Week 12 and Week 24)
研究者
Duk Lyul Na
Professor
Samsung Medical Center
研究点 (1)
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