Prevention of Alzheimer's Diseae by Vitamin E and Selenium

描述（由申请人提供）：阿尔茨海默病（AD）是最常见的迟发性痴呆症，在美国影响约四百万人，预计到2050年将影响1400万至1600万人。预防可能是消除AD的关键。很明显，氧化损伤在AD的发病机制中起作用，我们的研究表明，它存在于轻度认知障碍（MCI），AD的最早阶段，因此，预防措施应在症状前阶段开始。该研究项目是硒（Se）和维生素E前列腺癌预防试验（SELECT）的附加研究。SELECT研究由NCI资助，旨在评估硒和维生素E单独或联合使用对35，534名55岁或以上健康男性（如果是非裔美国人，则为50岁或以上）前列腺癌发病率降低的影响。通过维生素E和硒预防阿尔茨海默病（PREADVISE）评估了这些补充剂对减少6，100多名男性（其中17%是少数民族，从SELECT研究中招募）的AD和其他痴呆症的有效性。研究时间为12年。虽然SELECT已达到其招募目标，但PREADVISE已获准继续招募超过6，500名参与者。这是第一个随机对照试验，以评估抗氧化剂（维生素E和硒）对预防老年痴呆症的影响。具体目的是：1）确定Se和维生素E联合或单独使用在降低AD发病率方面的作用，如通过临床评价确定的，在参与SELECT的62岁或以上（60岁，如果是少数民族）的男性人群中; 2）评估Se和维生素E对减少其他神经退行性痴呆疾病的作用，同时确定补充剂对从正常到MCI和从MCI到AD和痴呆的转变的作用。3)在500名“通过”初始筛选的受试者中，通过深入的纵向认知评估验证两阶段筛选方法; 4）将PREADVISE中的受试者数量增加至6，504名或更多; 5）强调PREADVISE和SELECT中受试者的保留。

DESCRIPTION (provided by applicant): Alzheimer's Disease (AD), the most common late-onset dementing disorder, affects approximately four million individuals in the USA and is projected to affect 14 to 16 million individuals by the year 2050. Prevention may be the key to eliminate AD. It is clear that oxidative damage plays a role in the pathogenesis of AD, and our studies show that it is present in mild cognitive impairment (MCI), the earliest phase of AD, and thus, preventive measures should be initiated in the presymptomatic stages. This research project is an add-on study to the Selenium (Se) and Vitamin E Prostate Cancer Prevention Trial (SELECT). The SELECT study is funded by the NCI to assess the effect of Se and vitamin E, alone and in combination, on the reduction of incidence of prostate cancer in 35,534 healthy men age 55 or older (50 or older if African American). The Prevention of Alzheimer's Disease by Vitamin E and Selenium (PREADVISE) evaluates the effectiveness of these supplements on reducing incident AD and other dementias in a group of more than 6,100 men (17% of whom are minorities, recruited from the SELECT Study). The study duration is 12 years. While SELECT has reached its recruitment goal, PREADVISE has permission to continue recruiting to exceed 6,500 participants. This is the first randomized controlled trial to evaluate the effect of antioxidants (vitamin E and Se) on preventing dementia in the elderly. The specific aims are:1) To define the effect of Se and vitamin E, in combination and alone, in the reduction of the incidence of AD, as determined by the clinical evaluation, in a population of men age 62 or older (60 if minority) participating in SELECT; 2) To assess the effect of Se and vitamin E on the reduction of other neurodegenerative dementing diseases while also ascertaining the effect of the supplements on transition from normal to MCI and from MCI to AD and dementia;. 3) To validate the two-stage screening methodology with in-depth longitudinal cognitive assessments in a subset of 500 subjects who "pass" their initial screen; 4) To increase the number of subjects in PREADVISE to 6,504 or more; and 5) To emphasize retention of subjects in PREADVISE and SELECT.