GuidAge study: A 5-year double blind, randomised trial of EGb 761 for the prevention of Alzheimer's disease in elderly subjects with memory complaints. I. Rationale, design and baseline data
GuidAge study: A 5-year double blind, randomised trial of EGb 761 for the prevention of Alzheimer's disease in elderly subjects with memory complaints. I. Rationale, design and baseline data
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DOI：
10.2174/156720508785132271
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发表时间：
2008-08-01
影响因子：
2.1
通讯作者：
Vellas, Bruno
中科院分区：
文献类型：
--
作者：
Andrieu, Sandrine;Ousset, Pierre-Jean;Vellas, Bruno
阿尔茨海默病（AD）的一级和二级预防策略是迫切需要的。我们已经启动了一项为期五年的前瞻性预防研究，涉及自发报告记忆投诉的患者。主要目的是使用生存分析确定EGb 761（R）治疗对记忆主诉转化为AD的发生率的影响。年龄至少70岁的门诊患者，在GP或记忆中心咨询期间自发报告记忆投诉，符合入选条件。排除有主要客观记忆障碍或临床相关焦虑和抑郁症状的患者。受试者随机接受EGb 761 120 mg bid或匹配安慰剂。参与者每年在记忆中心接受一次访问，在那里进行一系列神经心理学测试以评估认知功能（Grober和Buschke，Trail-Making和受控口头单词联想测试）和认知状态（MMS和CDR）。使用工具性日常生活活动问卷评估功能状态。主要结局是在每年的记忆中心访视时确定的AD诊断（DSM-IV和NINCDS-ADRDA标准）的转变。共筛选了4066例患者参与研究，其中2854例符合合格标准并进入研究。他们的平均年龄为76.8 ± 4.4岁，66.7%为女性。平均MMSE评分为27.8 +/- 1.7，55.5%的CDR评分为0.5。这项研究将使我们能够评估EGb 761在预防AD方面的疗效，并评估各种基线特征作为该人群中AD转化预测因子的有用性。
Primary and secondary prevention strategies for Alzheimer's disease ( AD) are urgently needed. We have initiated a five-year prospective prevention study involving patients spontaneously reporting memory complaints. The primary objective is to determine the effect of treatment with EGb 761 (R) on the rate of conversion from memory complaints to AD using survival analysis. Ambulatory patients aged at least 70 years who spontaneously reported a memory complaint during a GP or memory centre consultation were eligible for inclusion. Patients with major objective memory impairment or clinically relevant symptoms of anxiety and depression were excluded. Subjects were randomised to receive either EGb 761 120mg bid or matching placebo. Participants undergo an annual visit at a memory centre, where a series of neuropsychological tests are administered to assess cognitive function (Grober and Buschke, Trail-Making and controlled oral word association tests) and cognitive status (MMS and CDR). Functional status is evaluated with the Instrumental Activities of Daily Living questionnaire. The primary outcome is the transition to a diagnosis of AD (DSM-IV and NINCDS-ADRDA criteria), determined at the annual memory centre visit. A total of 4066 patients were screened for participation, of whom 2854 fulfilled the eligibility criteria and were entered into the study. Their mean age was 76.8 +/- 4.4 years and 66.7% were female. The mean MMSE score was 27.8 +/- 1.7 and 55.5% presented a CDR score of 0.5. This study will enable us to evaluate the efficacy of EGb761 in the prevention of AD, and to assess the usefulness of various baseline characteristics as predictors of conversion to AD in this population.