NCT02572219已完成3 期
Effects of a Nutraceutical Preparation on Cognitive Impairment in Hypertensive Patients
Neuromed IRCCS2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2015年11月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Cognitive function assessed by neuropsychological tests
研究概览
简要总结
Aim of this randomized, double-blind clinical study is to evaluate the efficacy of a nutraceutical preparation on early markers of cognitive impairment, in patients affected by arterial hypertension.
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
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent;
- •Males or females between 40 and 65 years of age;
- •Hypertensive patients classified according to their SBP (Systolic Blood Pressure) and DBP (Diastolic Blood Pressure) values. Included patients will be those with stage 1 hypertension (SBP 140-159 mmHg; DBP 90-99 mmHg) and with stage 2 hypertension (SBP 160-179 mmHg; DBP 100-109 mmHg).
排除标准
- •Previous acute myocardial infarction (AMI);
- •Previous stroke and/or transient ischemic attack (TIA);
- •Diabetes mellitus;
- •History of atrial fibrillation or other severe arrhythmias;
- •Severe cardiovascular diseases;
- •Renal pathologies (creatinine > 1.4 mg/dL);
- •Preexisting psychiatric pathologies;
- •Neurodegenerative diseases, such as multiple sclerosis, lateral amyotrophic sclerosis, Parkinson, Alzheimer, neuromuscular pathologies, epilepsy;
- •Diagnosis of dementia;
- •Depression;
- •Long-term regular use of anxiolytics drugs, antidepressant drugs, antipsychotic drugs, hypnoinducing drugs, cognitive stimulators.
结局指标
主要结局
Cognitive function assessed by neuropsychological tests
时间窗: 6 months
Patients will be subjected to Montreal Cognitive Assessment (MoCA), Verbal fluency test, Word coupling test, Stroop test, and Instrumental Activities of Daily Living - IADL test. Assessments of cognitive functions will be performed by using unique score measurements defined in Units on a Scale.
次要结局
未报告次要终点
研究者
Giuseppe Lembo
prof. Giuseppe Lembo
Neuromed IRCCS
研究点 (2)
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