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障碍，在美国约有400万人受到影响，预计到2050年将有1400万至1600万人受到影响。预防可能是消除阿尔茨海默病的关键。氧化损伤在AD的发病机制中起重要作用，我们的研究表明，氧化损伤存在于AD的早期阶段--轻度认知损害(MCI)，因此，应在症状前阶段采取预防措施。这项研究项目是对硒和维生素E前列腺癌预防试验(SELECT)的补充研究。这项精选研究由美国国家癌症研究所资助，以评估单独和联合服用硒和维生素E对35,534名55岁及以上(如果非裔美国人为50岁或以上)健康男性前列腺癌发病率的降低效果。维生素E和硒预防阿尔茨海默氏症(PREADVISE)评估了这些补充剂在6100多名男性(其中17%是少数族裔，从选择的研究中招募)中减少AD和其他痴呆症的有效性。研究时间为12年。虽然SELECT已经达到招募目标，但PREADVISE有权继续招募超过6500名参与者。这是第一个评估抗氧化剂(维生素E和硒)预防老年人痴呆症效果的随机对照试验。具体目的是：1)确定在参与SELECT的62岁或以上男性(如果是少数人，则为60人)中，硒和维生素E联合和单独使用在降低AD发病率方面的效果；2)评估Se和维生素E在减少其他神经退行性痴呆疾病方面的效果，同时还确定补充剂在从正常到MCI以及从MCI到AD和痴呆的转变中的作用；3)对500名通过初步筛查的受试者进行深入的纵向认知评估，以验证两阶段筛查方法；4)将PREADVISE中的受试者数量增加到6,504人或更多；以及5)强调保留PREADVISE中的受试者并进行选择。

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.