NCT00746005已完成不适用
Challenge Study: The Efficacy of Fish Oil Supplementation on Cognitive Performance in MCI Patients and the Influence of the APOE-epsilon4 Allele
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- cognitive performance
研究概览
简要总结
To study the short term effects of a pharmacological dose of fish oil on cognitive performance and on cerebral blood flow. Furthermore, we want to investigate whether carriers of the APOEε4 allele respond differently to fish oil treatment compared to non-carriers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women
- •Diagnosed as having amnestic MCI: based on specific memory disturbances (cut-off of 1 sd, single or multiple domain amnestic MCI, according to Busse A et al37)
- •Presence of a principal caregiver willing to assist for a successful participation
- •Informed consent signed
排除标准
- •Current or recent (<4 weeks) use of fish oil supplements
- •Consumption of fish more than 2 times/week
- •Current use of dementia (Alzheimer) medication
- •Current use of acenocoumarol or other anti-thrombotic drugs (because of the high dose of fish oil)
- •Serious liver disease
- •Use of more than 4 glasses of alcohol per day
- •Unable to participate as judged by the responsible medical physician
- •Allergy to fish(oil)
- •Swallowing problems
- •Participation in another clinical trial less than 2 months before the start of the trial or at the same time
结局指标
主要结局
cognitive performance
时间窗: baseline and after 4 weeks
次要结局
- blood flow-velocity in the middle cerebral arteries (assessed with TCD) and cortical tissue oxygenation, cerebral autoregulation, cerebral blood volume (assessed with NIRS(baseline and after 4 weeks)
研究者
研究点 (4)
Loading locations...
相似试验
终止
不适用
Fish Oil Supplements for Recovery after Mild Traumatic Brain Injury (mTBI): A Randomised Control TrialMild Traumatic Brain InjuryInjuries and Accidents - Other injuries and accidentsNeurological - Other neurological disordersACTRN12617000040369Massey University12
已完成
不适用
Effect of Krill Oil on Cognitive Function in AdultsSubjective Memory ImpairmentNCT04347421Pusan National University Yangsan Hospital100
已完成
1 期
Fish Oil vs. Placebo on Subjective Effects of AlcoholAlcohol DependenceNCT03010917Yale University17
尚未招募
不适用
Challenge study: The efficacy of fish oil supplementation on cognitive performance in MCI patients and the influence of the APOE-epsilon4 allele.cognitive decline10012272NL-OMON32051Wageningen Universiteit40
Unknown
4 期
Omega 3 and Ischemic Stroke; Fish Oil as an OptionIschemic StrokeNeurological InjuryStroke, AcuteInflammatory ResponsePermanent InjuryNeurologic DysfunctionNeurological DisorderBrain IschemiaBrain InjuriesNCT04386525King Fahad Medical City60