Potential ethnic modifiers in the assessment and treatment of Alzheimer's disease: challenges for the future
Potential ethnic modifiers in the assessment and treatment of Alzheimer's disease: challenges for the future
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DOI：
10.1017/s104161020700511x
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发表时间：
2007-06-01
影响因子：
7
通讯作者：
Mintzer, Jacobo E.
中科院分区：
文献类型：
--
作者：
Faison, Warachal E.;Schultz, Susan K.;Mintzer, Jacobo E.
目的：尽管进行了大量的临床试验，但种族是否影响认知增强剂对阿尔茨海默病(AD)的治疗反应尚不清楚。有令人信服的证据表明，药物代谢存在种族和遗传差异。本文回顾了阿尔茨海默病临床试验中关于种族的现有数据，以回答两个问题：(1)不同种族之间诊断和治疗AD面临的挑战是什么？(2)不同种族之间对药物干预AD的反应是否存在差异？方法：现有数据来自阿尔茨海默病合作研究(ADCS)随机对照临床试验和行业赞助的四种认知增强剂(多奈哌齐、加兰他明、利瓦斯汀和沙贝鲁唑)的随机对照试验，以评估非高加索参与者的数量。结果：少数民族受试者参与AD临床试验的资金来源有关，尽管高加索人参与者比例过高，而非高加索人参与者在临床试验中的比例偏低。由于少数民族的参与率较低，没有足够的数据来评估不同种族之间治疗结果的任何差异。讨论了提高临床试验多样性的策略。结论：更多不同种族的参与者参与阿尔茨海默病的临床试验将产生关于代谢、治疗反应、治疗药物不良事件的可能差异的额外信息，并可能促进对种族间遗传变异的调查。
Objective: Despite numerous clinical trials, it is unknown whether ethnicity affects treatment response to cognitive enhancers in Alzheimer's disease (AD). There is convincing evidence of ethnic and genetic variability in drug metabolism. This article reviews the available data on ethnicity in clinical trials for AD to answer two questions: (1) what are the challenges to diagnose and treat AD across different ethnic groups, and (2) are there differences in response to pharmacologic interventions for AD across these different ethnic groups?Method: Available data from Alzheimer's Disease Cooperative Study (ADCS) randomized controlled clinical trials and from randomized controlled industry-sponsored trials for four cognitive enhancers (donepezil, galantamine, rivastigmine and sabeluzole) were pooled to assess the numbers of non-Caucasian participants.Results: The participation of ethnic minority subjects in clinical trials for AD was dependent on the funding source, although Caucasian participants were over-represented and non-Caucasian participants were under-represented in the clinical trials. Because of the low participation rate of ethnic minorities, there were insufficient data to assess any differences in treatment outcome among different ethnic groups. Strategies to improve diversity in clinical trials are discussed.Conclusion: Greater participation of ethnically diverse participants in clinical trials for AD would generate additional information on possible differences in metabolism, treatment response, adverse events to therapeutic agents, and could foster the investigation of genetic variability among ethnic groups.