Fish oil & alpha lipoic acid in mild Alzheimer's disease

鱼油

• 批准号: 6804713
• 负责人: LYNNE H SHINTO
• 金额: $ 17.96万
• 依托单位: OREGON HEALTH & SCIENCE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-09-30 至 2007-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6804713
• 关键词: Alzheimer' s disease; acute phase protein; antioxidants; brain disorder chemotherapy; clinical research; clinical trials; cognition disorders; diet therapy; dietary supplements; human middle age (35-64); human old age (65+); human subject; human therapy evaluation; inflammation; marine animal oil; nutrition related tag; oxidative stress; patient oriented research; quality of life

DESCRIPTION (provided by applicant): The heterogeneous nature of the biological mechanisms associated with Alzheimer's disease (AD) pathology make therapies that can target multiple mechanisms of action rather than a single mechanism attractive candidates to delay or prevent disease progression. Oxidative stress has been highly implicated in Alzheimer's disease pathology and recent studies show there is also an association between an increase in inflammation and cholesterol (respectively), and AD pathology. Fish oil and alpha lipoic also have the ability to decrease oxidative stress, inflammation, and lipid levels, making them strong candidates as therapeutic agents in slowing the progression of Alzheimer's disease. These supplements also have few reported side effects. Based on their mechanisms of action, a combination of the two supplements has the potential to maximize the therapeutic benefit in delaying the progression in AD. The proposed study will be a pilot trial designed to collect preliminary data to aid in the design of a larger clinical trial powered to assess both treatments' effect on mechanisms associated with AD pathology and clinical markers of AD pathology. This pilot study is designed as a 3-arm, parallel group, double-blind placebo-controlled trial. Subjects >55 yrs. diagnosed with probable AD and having mild cognitive impairment will be randomized to one of three groups (13 subjects/group): 1. fish oil alone, 2. fish oil plus alpha lipoic acid, 3. placebo. The treatment intervention will be for 1-year. Our primary objective, Aim 1, is to assess the treatments' effect on oxidative stress by measuring urine F2-isoprotane levels. We will also collect preliminary data on the treatments' effect on plasma lipid levels and high-sensitivity C-reactive protein. Our secondary objective, Aim 2, is to collect preliminary data on AD-related clinical outcome measures which will include: the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog), Clinical Dementia Rating scale (CDR), Mini Mental State Examination (MMSE), Alzheimer's Disease Cooperative Study Activities of Daily Living Scale, SF-36, and Logical Memory I1.Our tertiary objective, Aim 3, is to assess treatment safety by a monthly monitoring of adverse events and laboratory tests (metabolic panel, including liver function tests and platelet function assay). Compliance of fish oil supplementation will be assessed by red blood cell membrane fatty acid analysis.

描述（由申请人提供）：与阿尔茨海默氏病（AD）病理学相关的生物学机制的异质性质，使疗法可以针对多种作用机理，而不是一种有吸引力的候选者来延迟或防止疾病进展。氧化应激与阿尔茨海默氏病的病理高度涉及，最近的研究表明，炎症和胆固醇分别（分别）（分别）（分别）与AD病理学之间存在关联。鱼油和αlipoic还具有降低氧化应激，炎症和脂质水平的能力，使其成为强大的候选者，成为降低阿尔茨海默氏病进展的治疗剂。这些补充剂也很少报道的副作用。根据它们的作用机制，两种补充剂的组合具有最大化治疗益处在延迟AD进展方面的最大程度。拟议的研究将是一项试点试验，旨在收集初步数据，以帮助设计较大的临床试验，该试验旨在评估两种治疗方法对与AD病理学和AD病理学的临床标志物相关的机制的影响。这项试验研究被设计为一项3臂平行组，双盲安慰剂对照试验。受试者> 55岁。被诊断为可能的AD和轻度认知障碍的可能会随机分为三组之一（13个受试者/组）：1。单独使用鱼油，2。鱼油加α脂酸，3。安慰剂。治疗干预措施将持续1年。我们的主要目标是目标1，是通过测量尿液F2-异丙烷水平来评估治疗对氧化应激的影响。我们还将收集有关治疗对等离子体脂质水平和高敏C反应蛋白的影响的初步数据。我们的次要目标（目的2）是收集有关与广告相关的临床结局指标的初步数据，其中包括：阿尔茨海默氏病评估评估量表量表认知子量表（ADAS-COG），临床痴呆率评级量表（CDR），MINI心理状态检查，MINI心理状态检查（MMSE），Alzheimer的Alzheimer疾病合作的研究量表，其目的是TRIG TORICER ITION ITION ITIOL IT TROMITION IT i尺度和SF-36，SF-3。 3，是通过每月监测不良事件和实验室测试（代谢面板，包括肝功能测试和血小板功能测定法）来评估治疗安全。补充鱼油的依从性将通过红细胞膜脂肪酸分析评估。