JPRN-jRCTs051230013招募中2 期
Resveratrol for vascular cognitive impairment investigating cerebralmetabolism and perfusion - REVAMP trial
Hattori Yorito0 个研究点目标入组 100 人开始时间: 2023年4月13日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
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
- >= 20age old 至 < 90age old（—）
- 性别
- All
入选标准
- •1) Age at 20-90 years
- •2) Subjects with asymptomatic carotid artery moderate or severe stenosis, or occlusion
- •* Definition of moderate stenosis: 130 cm/s or faster of peak systokic velocity (PSV) ata stenotic lesion shown by carotid ultrasonography
- •*Definiation of asymptomatic status: no cerebral infarction ipsilateral to carotid artery stenosis/occlusive lesion within 6 months
- •3) Subjects who signed an informed consent form
排除标准
- •1) Severe demented patients who fail to conduct cognitive tests.
- •2) Parients taking donepezil, galantamine, rivastigmine, and memantine.
- •3) Patients with secondary dementia (Parkinson's disease, Huntingon's disease, normal pressure hydrocephalus, pregoressive supranuclear palsy, multiple system atrophy, multiple sclerosis, head injury with sequelae, neurosyphilis, hypothyroidism, vitamin B1/B12 deficiency, folic acid deficiency)
- •4) Patients with more than 50% stenosis or occlusion of intracranial basilar artery, and vertebral artery
- •5) Patients with a past history of intrinsic psychiatric disease, or alcohol or drug dependence within 48 weeks prior to informed consent
- •6) Patients with severe pulmoary diseases (e.g., under home oxygen therapy)
- •7) Patients with a history of dose change in statins, PCSK9 inhibitors, intestinal cholesterol transporter inhibitors, and phosphodiesterase inhibitors within 4 weeks prior to informed consent
- •8) Patients who do not quit intake of resveratrol or nicotinamide mononucleotide by 4 weeks prior to administration of the experimental drugs
- •9) Patients with severe renal dysfunction (eGFR<15 mL/min/1.73m2, or hemodyalisis).
- •10) Patients who experienced malignancy within past five years.
- •11) Pregnant and breastfeeding women, or patients who do not agree with contraception.
- •12) Patients participating in or planning to participate in other clinical trials using other medicines ormedical devices.
- •13) Patients whose participation in this study is regarded as inappropriate by the principal investigator or co-investigators.
研究者
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