Vitamin E and memantine in Alzheimer's disease: clinical trial methods and baseline data.
Vitamin E and memantine in Alzheimer's disease: clinical trial methods and baseline data.
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DOI：
10.1016/j.jalz.2013.01.014
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发表时间：
2014-01
期刊：
影响因子：
--
通讯作者：
Vatassery G
中科院分区：
文献类型：
--
作者：
Dysken MW;Guarino PD;Vertrees JE;Asthana S;Sano M;Llorente M;Pallaki M;Love S;Schellenberg GD;McCarten JR;Malphurs J;Prieto S;Chen P;Loreck DJ;Carney S;Trapp G;Bakshi RS;Mintzer JE;Heidebrink JL;Vidal-Cardona A;Arroyo LM;Cruz AR;Kowall NW;Chopra MP;Craft S;Thielke S;Turvey CL;Woodman C;Monnell KA;Gordon K;Tomaska J;Vatassery G
描述退伍军人事务部合作研究计划试验的方法和基线特征，该试验旨在比较1)维生素E抗氧化剂α-生育酚、2)NMDA拮抗剂美金刚(Namenda®)、3)它们的组合和4)安慰剂在延缓阿尔茨海默病临床进展方面的有效性。14个退伍军人医学中心的多中心、随机、安慰剂对照试验。613名被诊断为可能或可能患有轻度至中度阿尔茨海默病的患者，定义为简易智力状态检查(MMSE)总分在12至26分之间，正在服用乙酰胆碱酯酶抑制剂。：2,000国际单位/天的α-生育酚+安慰剂，20毫克/天的美金刚+安慰剂，2,000国际单位/天的α-生育酚+20毫克/天的美金刚，或双倍安慰剂。主要结果是阿尔茨海默病合作研究/日常生活活动清单(ADCS-ADL)。次要结果测量包括MMSE、阿尔茨海默病评估量表-认知部分、依赖量表、神经精神病学问卷和照顾者活动调查。大多数登记的患者是男性(97%)，白人(86%)，平均年龄79岁。入院时ADCS-ADL和MMSE的平均分分别为57和21。这项大型多中心试验将解决一个悬而未决的问题，即在服用乙酰胆碱酯酶抑制剂的轻至中度阿尔茨海默病患者中，α-生育酚、美金刚及其组合的长期安全性和有效性。结果预计将在2013年初公布。
To describe the methods and baseline characteristics of a VA Cooperative Studies Program trial designed to compare the effectiveness of 1) alpha-tocopherol, a vitamin E antioxidant, 2) memantine (Namenda®), an NMDA antagonist, 3) their combination, and 4) placebo in delaying clinical progression in Alzheimer disease. Multi-center, randomized, placebo controlled trial 14 VA medical centers. 613 patients with a diagnosis of possible or probable Alzheimer's disease of mild-to-moderate severity defined as a Mini-Mental State Examination (MMSE) total score between 12 and 26 inclusive who were taking an acetylcholinesterase inhibitor. : 2,000 IU/day of alpha-tocopherol + placebo, 20 mg/day of memantine + placebo, 2,000 IU/day of alpha-tocopherol + 20 mg/day of memantine, or double placebo. The primary outcome is the Alzheimer's Disease Cooperative Study/Activities of Daily Living Inventory (ADCS-ADL). Secondary outcome measures include the MMSE, the Alzheimer's Disease Assessment Scale - Cognitive portion, the Dependence Scale, the Neuropsychiatric Inventory, and the Caregiver Activity Survey. The majority of the enrolled patients were male (97%), white (86%) with a mean age of 79. The mean scores of the ADCS-ADL, and MMSE, at entry were 57, and 21, respectively. This large multicenter trial will address the unanswered question of the long-term safety and effectiveness of alpha-tocopherol, memantine and their combination in patients with mild-to-moderate Alzheimer's disease taking an acetylcholinesterase inhibitor. The results are expected in early 2013.
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DOI：
10.1016/0277-5379(86)90133-1
发表时间：
1986-11-01
期刊：
EUROPEAN JOURNAL OF CANCER & CLINICAL ONCOLOGY
影响因子：
--
作者：
HAYBITTLE, JL
通讯作者：
HAYBITTLE, JL
影响因子：
9.9
作者：
MCKHANN, G;DRACHMAN, D;STADLAN, EM
通讯作者：
STADLAN, EM
影响因子：
4.8
作者：
FOLSTEIN, MF;FOLSTEIN, SE;MCHUGH, PR
通讯作者：
MCHUGH, PR
DOI：
10.1016/0021-9681(87)90171-8
发表时间：
1987-01-01
期刊：
JOURNAL OF CHRONIC DISEASES
影响因子：
--
作者：
CHARLSON, ME;POMPEI, P;MACKENZIE, CR
通讯作者：
MACKENZIE, CR
影响因子：
120.7
作者：
Gaziano, J. Michael;Glynn, Robert J.;Christen, William G.;Kurth, Tobias;Belanger, Charlene;MacFadyen, Jean;Bubes, Vadim;Manson, Joann E.;Sesso, Howard D.;Buring, Julie E.
通讯作者：
Buring, Julie E.