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）是最常见的晚发性痴呆疾病，在美国影响了大约400万人，预计到2050年将影响1400万至1600万人。预防可能是消除阿尔茨海默病的关键。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。本研究项目是硒（Se）和维生素E预防前列腺癌试验（SELECT）的补充研究。SELECT研究是由NCI资助的，目的是评估硒和维生素E单独或联合使用对35,534名55岁或以上的健康男性（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）在6100多名男性（其中17%是少数民族，从SELECT研究招募）中评估了这些补充剂在减少AD和其他痴呆症发生率方面的有效性。研究时间为12年。虽然SELECT已经达到了招募目标，但PREADVISE已获准继续招募超过6,500名参与者。这是第一个评估抗氧化剂（维生素E和硒）在预防老年人痴呆方面效果的随机对照试验。具体目的是：1)确定硒和维生素E联合使用和单独使用在临床评估确定的62岁或以上（少数人群为60岁）参加SELECT的男性人群中降低AD发病率的作用；2)评估硒和维生素E对减少其他神经退行性痴呆疾病的作用，同时确定补充硒和维生素E对从正常到轻度认知障碍、从轻度认知障碍到AD和痴呆的过渡的影响；3)对500名“通过”初始筛选的受试者进行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到6504或更多；5)在PREADVISE和SELECT中强调主题的保留。

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.