The Delivery of Essential Fatty Acids to the Brain
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 365
- 试验地点
- 1
- 主要终点
- change in cerebrospinal fluid fatty acid levels after the intervention in 184 subjects
研究概览
简要总结
Carrying the APOE ɛ4 allele is the strongest genetic risk factor for developing Alzheimer's disease. The goal of this project is to identify whether carrying the APOE ɛ4 allele is associated with reduced delivery of DHA to the brain. This information will help us identify the target population that could benefit from DHA supplementation to prevent cognitive decline.
详细描述
The Brain DHA Delivery Trial will examine the effect of APOE genotype on the changes of cerebrospinal fluid (CSF) DHA to Arachidonic acid (AA) ratio in 184 cognitively healthy older individuals in response to DHA supplementation. Randomized clinical trials have yielded mixed results on the effect DHA supplementation on cognitive outcomes. This study asks the critical question of whether DHA gets into the brain in sufficient amounts after supplementation, and whether APOE genotype affects brain penetrance.
This trial will also test the effect of DHA supplementation on changes in brain structural and functional connectivity assessed by MRI, and changes in cognition after two years of supplementation in all 368 participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: ≥ 55 and ≤ 80
- •At least one dementia risk factor (obesity, education years, hypertension, hyperlipidemia)
- •Mini-Mental State Examination (MMSE) ≥ 25
- •Logical Memory II delayed recall score ≥ 6 and ≤ 18 .
排除标准
- •Diagnosis of dementia as assessed by the investigator
- •Use of omega-3 preparations in the last 3 months
- •> 200 mg/day of DHA consumption using a validated questionnaire
- •Use of donepezil, rivastigmine, galantamine and/or memantine
- •Alcohol or drug abuse
- •A concomitant serious disease such as active cancer treatment or HIV.
- •Participation in a clinical trial in the last 30 days
- •Use of anticoagulants such as Plavix or Coumadin or the newer generation blood thinners.
研究组 & 干预措施
DHA
oral DHA supplementation at 2 grams per day
干预措施: DHA (Drug)
Placebo
Placebo for DHA
干预措施: Placebo (Drug)
结局指标
主要结局
change in cerebrospinal fluid fatty acid levels after the intervention in 184 subjects
时间窗: 6 months
cerebrospinal fluid fatty acids assessed by mass spectrometry
次要结局
未报告次要终点
研究者
Hussein Yassine
Assistant Professor
University of Southern California