ACTRN12622001576718招募中2 期
Effects of a biofactor-combination on cognitive function in mildly cognitiveimpaired patients - a randomized, phase IIa, double-blind, placebo-controlledpilot-trial
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 60 Years 至 o limit（—）
- 性别
- All
入选标准
- •Men and women 60 years or older
- •Subjectively felt memory complaints that are defined as worrisome by the subject
- •Impairment in one or more cognitive domains, identified as the person scoring >1 standard deviation below the normative data for their age and/ or estimated levels of
- •premorbid functioning as identified by a neuropsychological screening battery
- •Montreal Cognitive Assessment (MoCA) score equal to or greater than 17
- •Geriatric Depression Scale (short form) score equal to or less than 10
- •Functional Activities Questionnaire score equal to or less than 6
- •Preserved activities of daily living and an absence of dementia
- •Able to comply with all procedures linked to this trial, including the intake of all daily doses of investigational medical product
排除标准
- •Any ongoing concomitant disease that may influence cognitive functions
- •Under treatment with drugs or supplements that interfere with cognitive functions within the two months before randomisation
- •Any previous treatment with acetylcholinesterase inhibitors or other AD disease modifying drugs
- •Any contraindication to the use of the investigational medical product
- •Significant or insufficiently treated hepatic, renal, respiratory, cardiovascular, metabolic, oncological, immunological or hormonal disorders
- •Major cardiovascular event, such as a myocardial infarction or stroke, in the last 12 months before randomisation
- •Carotid stents or severe stenosis
- •Any other existing medical conditions likely to affect the study measures (as judged by the clinical investigator)
- •Uncontrolled hypertension (systolic blood pressure (SBP) >160 mm Hg, diastolic blood pressure (DBP) >100 mm Hg)
- •BMI equal to or greater than 40kg/m2
- •History of allergy/hypersensitivity to drugs or to the investigational medical product
- •Treatment with any drugs or food supplements containing vitamins and minerals in the investigational medical product must be stopped 2 months before randomisation
- •Current smokers, or having stopped smoking < 6 months before randomisation
- •Use of recreational drugs
- •Participation in another clinical study within the 2 months preceding randomisation
- •Not able to comply with the study requirements
- •not willing or able to sign the informed consent
研究者
相似试验
招募中
2 期
A study of effects on cognitive function and neuropsychiatric symptoms in patients with mild to moderate Alzheimer's diseaseCognitive function and neuropsychiatric symptoms in patients with mild to moderate Alzheimer's diseasePericarp mangosteen extract, Alzheimer'TCTR20170509001Department for Development of Thai Traditional and Alternative Medicine, Ministry of Public Health180
已完成
不适用
Effect on cognitive function.Healthy subjectsJPRN-UMIN000031366CPCC Company Limited14
已完成
不适用
Relationships between cognitive function and biomarkersJPRN-UMIN000039486Kao Corporation40
已完成
不适用
Psychological, cognitive and neural factors associated with distinct profiles of mood change following the dissolution of a romantic relationshipemotional statemood10027946NL-OMON48640niversitair Medisch Centrum Groningen130
Unknown
不适用
Romantic relationship breakup and mood changesmooddepressionheartbreakbreakupstemmingdepressieliefdesverdrietrelatieverbrekingNL-OMON25623niversity Medical Center Groningen130