PREVENTION OF ALZHEIMER'S BY VITAMIN E AND SELENIUM

描述：阿尔茨海默病(AD)，是美国的一个主要健康问题 在各州，它影响到大约400万老年人。的确有 阿尔茨海默病没有有效的治疗方法和预防措施，是解决这一障碍的关键。 氧化应激，表现为脂肪、蛋白质、碳水化合物和DNA氧化 在AD神经元变性的发病机制中起重要作用 作为一个潜在的治疗靶点来延缓发病或预防 这种疾病。本申请称为PREADVISE，基于 假说早期使用维生素E和硒(Se)治疗 本病症状前阶段可延缓或预防AD的发病。这些 两种抗氧化剂都有很强的抗氧化性，还没有一起使用 在一项大规模的人体研究中。建议对AD预防进行的评估将被添加 硒和维生素E化学预防试验(SELECT)，一项由NCI支持的， 第三阶段，双盲，安慰剂对照的2X2析因研究，评估 这两种抗氧化剂联用和单独作用对小鼠脑缺血再灌注损伤的影响 55岁及以上(50岁或以上)健康男性32,400人的前列腺癌发病率 如果是非裔美国人)。遴选的期限为12年，其中5年为 统一应计期。PREADVISE向65岁或65岁以上的男性开放(60岁或以上，如果 少数族裔)，估计将有10,368人参加。他们 将被随机分成四组：维生素E加硒，维生素E加硒 安慰剂，硒加维生素E安慰剂，或维生素E加硒安慰剂。他们会 接受记忆障碍筛查检查，作为初始和 年度精选评估，低于分界点的将 使用该联盟进行更全面的认知评估，以建立 阿尔茨海默病(CERAD)系列认知测试登记。 未能通过CERAD电池测试的参与者将患上彻底的痴呆症 用于诊断的医学评估，并在协商一致的会议上由 神经学家和在痴呆症方面有长期经验的神经心理学家。它是 估计AD的相对风险(相对风险0.60)可通过 在这场审判中80%的权力。这项研究提供了一个廉价的机会来 评估两种抗氧化剂延缓发病的长期效果 在大量的受试者中预防AD。这项研究还将评估 筛查方法在配对样本中的敏感性和特异性 法线。此外，它还将评估抗氧化治疗的效果。 200名老年人纵向跟踪正常对照组。

DESCRIPTION: Alzheimer's disease (AD), is a major health problem in the United States, where it affects approximately four million older individuals. There is no effective treatment of AD and prevention is the key to this disorder. Oxidative stress, in the form of lipid, protein, carbohydrate and DNA oxidation plays a significant role in the pathogenesis of neuron degeneration in AD and serves as a potential therapeutic target for slowing the onset or preventing the disease. The present application, termed PREADVISE, is based on the hypothesis that early treatment with vitamin E and selenium (Se) in the presymptomatic stage of the disease may delay the onset or prevent AD. These two agents have strong antioxidant properties and have not been used together in a large human study. This proposed evaluation of AD prevention will be added to the Selenium and Vitamin E Chemoprevention Trial (SELECT), a NCI-supported, phase III, double-blind, placebo-controlled 2X2 factorial study that assesses the combined and single effect of these two antioxidants on the reduction of the incidence of prostate cancer in 32,400 healthy men 55 or older (50 or older if African American). The duration of SELECT will be 12 years with a five-year uniform accrual period. PREADVISE is open to men 65 or older (60 or older if a minority) and it is estimated that 10,368 participants will be enrolled. They will be randomized to one of four arms: vitamin E plus Se, vitamin E plus Se placebo, Se plus vitamin E placebo, or vitamin E and Se placebos. They will undergo a memory impairment screening examination as part of the initial and annual SELECT evaluation, and those that fall below the cutoff point will undergo a more thorough cognitive evaluation using the Consortium to Establish a Registry for Alzheimer's Disease (CERAD) battery of cognitive tests. Participants who fail the CERAD battery will receive a thorough dementia medical evaluation for diagnosis and be reviewed in a consensus conference by neurologists and a neuropsychologist with lengthy experience in dementia. It is estimated that the relative risk for AD (relative risk 0.60) is detectable with 80 percent power in this trial. The study offers an inexpensive opportunity to evaluate the long-term effect of two antioxidant agents in slowing the onset or preventing AD in a large number of subjects. The study also will evaluate the sensitivity and specificity of the screening measure in a matched sample of normals. In addition, it will evaluate the effect of antioxidant therapy in a group of 200 elderly longitudinally followed normal controls.