PREVENTION OF ALZHEIMER'S BY VITAMIN E AND SELENIUM

本申请是一项名为《维生素预防阿尔茨海默氏病》的研究的五年续展申请 E和硒“(PREADVISE)。PREADVISE是对前列腺硒和维生素E的补充研究 癌症预防试验(SELECT)，国家癌症研究所资助的III期，双盲，2x2因素 一项随机对照试验，以评估硒或维生素E或两者联合使用对降低高血压的效果 35,534名健康男性的前列腺癌发病率。研究时间为12年。 预防是消除阿尔茨海默病(AD)的关键。多项研究表明， 脂质、蛋白质、DNA和RNA的氧化损伤在神经变性的发病机制中起作用 广告。最近的研究表明，轻度认知障碍存在明显的氧化损伤， 这种疾病最早可检测到的形式。人群研究也建议使用抗氧化剂预防AD 并强调在AD中进行大规模、长期、随机对照抗氧化剂试验的必要性。因此， 将减少氧化应激/损伤作为减缓或预防阿尔茨海默病的一种手段的理由是成立的 坚实的基础。PREADVISE的目的是确定Se和/或维生素E对减少 AD和其他神经退行性疾病的发生率，并评估硒和维生素E对 参与者中的一小部分人的正常认知老化。同样在这个五年计划阶段，重点将是 放置在PREADVISE和SELECT中保留主题。 PREADVISE招募了5100名参与者，其中18%是少数民族。另有1300人 有资格参加PREADVISE。PREADVISE的受试者被随机分为四组：维生素 维生素E加Se，维生素E加Se安慰剂，Se加维生素E安慰剂，Se安慰剂加维生素E安慰剂。 作为初始评估的一部分，参与者将接受记忆障碍筛查检查 此后每年一次。那些低于分界点的人会接受更彻底的认知评估 使用该联盟建立阿尔茨海默病注册中心(CERAD)的一系列认知测试。 CERAD电池失败的受试者将接受全面的痴呆症评估，该评估由一名 共识会议。DNA可用于载脂蛋白E基因测试和其他遗传因素的未来研究 在公元后。这是国内和国际上最大的AD预防试验，基于一项创新和 具有独特成本效益的跨学院协作分项研究模式

This application is for a five-year renewal of the study entitled, "Prevention of Alzheimer's Disease by Vitamin E and Selenium" (PREADVISE). PREADVISE is an add-on study to the Selenium and Vitamin E Prostate Cancer Prevention Trial (SELECT), a National Cancer Institute funded phase III, double blind, 2x2 factorial randomized control trial to assess the effect of Se or vitamin E or the combination of both on the reduction of the incidence of prostate cancer in 35,534 healthy men. The study duration is 12 years. Prevention is the key to eliminating Alzheimer's disease (AD). Multiple studies have demonstrated that oxidative damage to lipids, proteins, DMA, and RNA plays a role in the pathogenesis of neurodegeneration in AD. Recent studies have shown that marked oxidative damage is present in mild cognitive impairment, the earliest detectable form of the disease. Population studies also suggest using antioxidants for AD prevention and underscore the need for large scale, long term, randomized controlled trials of antioxidants in AD. Thus, the rationale for diminishing oxidative stress/damage as a means of slowing the onset or preventing AD is on a solid basis. The aims of PREADVISE are to define the effect of Se and/or vitamin E on the reduction of the incidence of AD and other neurodegenerative diseases, and to assess the effect of Se and vitamin E on normal cognitive aging in a sub-sample of participants. Also during this five year phase, emphasis will be placed on retention of subjects in PREADVISE and SELECT. PREADVISE has recruited 5,100 participants and 18% of these are ethnic minorities. Another 1,300 men are eligible for enrollment in PREADVISE. PREADVISE subjects are randomized to one of four arms:vitamin E plus Se, vitamin E plus Se placebo, Se plus vitamin E placebo, and Se placebo plus vitamin E placebo. Participants undergo a memory impairment screening examination as part of the initial evaluation and annuallly thereafter. Those that fall below the cut off point undergo a more thorough cognitive evaluation using the Consortium to Establish a Registry for Alzheimer's Disease (CERAD) battery of cognitive tests. Subjects who fail the CERAD battery receive a thorough dementia evaluation that is reviewed by a consensus conference. DNA is available for APOE genotype testing and future study of other genetic factors in AD. This is the largest national and international prevention trial of AD and is based on an innovative and inter-institute collaborative sub-study model that is uniquely cost effective