MULTICENTER VITAMIN E TRIAL--PERSONS WITH DOWN SYNDROME

多中心维生素 E 试验——唐氏综合症患者

• 批准号: 2908832
• 负责人: ARTHUR DALTON
• 金额: $ 146.52万
• 依托单位: INSTITUTE FOR BASIC RES IN DEV DISABIL
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-09-30 至 2005-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2908832
• 关键词: Alzheimer's disease; Downs syndrome; aging; chemoprevention; clinical research; clinical trials; comorbidity; cooperative study; functional ability; human middle age (35-64); human old age (65+); human subject; human therapy evaluation; international cooperation; longitudinal human study; mental disorder chemotherapy; nervous system disorder chemotherapy; nutrition related tag; tocopherols; vitamin therapy

DESCRIPTION: (Adapted from the application) There is evidence from a multicenter clinical trial that vitamin E slows the rate of clinical deterioration in individuals with moderately severe Alzheimer s disease (AD). The AD Cooperative Study (ADCS) is now mounting a large study to test the effects of vitamin E in persons at the earliest stage of cognitive deterioration. Older individuals with Down syndrome (DS) are at very high risk for AD. Most individuals with DS develop functional decline and show neuropathological evidence of AD by the sixth decade. The applicants propose an international multicenter randomized double-blind study to determine whether vitamin E supplementation will slow the rate of cognitive/functional decline in individuals with DS. Subjects with DS who are at least 50 years of age will be randomized into two treatment groups: vitamin E 2000 IU plus a multivitamin per day or placebo plus multivitamin. The multivitamin contains vitamin E 15 IU. The treatment period will be three years with evaluation visits every six months. The primary outcome measure will be a three year change score on a cognitive/functional measure that was derived for this purpose from the DYSPRAXIA Scale for Adults with Down Syndrome. Secondary outcome measures will include additional cognitive tests as well as informant-based measures of function and behavior.

描述：（从应用程序改编）有一个证据 维生素E的多中心临床试验减慢了临床的速度 中度严重的阿尔茨海默氏病（AD）的个体恶化。 AD合作研究（ADC）现在正在进行一项大型研究，以测试 维生素E在最早的认知阶段的影响 恶化。 唐氏综合症（DS）的老年人很高 AD风险。 大多数患有DS的人会发展功能下降并显示 第六个十年来的AD神经病理学证据。 申请人建议 一项国际多中心随机双盲研究，以确定 维生素E补充是否会减慢认知/功能的速度 患有DS的人的下降。 具有至少50年的DS的受试者 年龄将被随机分为两个治疗组：维生素E 2000 IU加上 每天多种维生素或安慰剂和多种维生素。 多种维生素含有 维生素E 15 IU。 治疗期为三年，评估 每六个月访问一次。 主要结局措施将是三年 在为此得出的认知/功能度量方面的变更评分 唐氏综合症成年人的不良规模量表的目的。 次要 结果指标将包括其他认知测试以及 基于线人的功能和行为度量。