Older patients are still under-represented in clinical trials of Alzheimer's disease.
Older patients are still under-represented in clinical trials of Alzheimer's disease.
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DOI：
10.1186/s13195-016-0201-2
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发表时间：
2016-08-12
期刊：
影响因子：
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通讯作者：
Lucca U
中科院分区：
文献类型：
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作者：
Banzi R;Camaioni P;Tettamanti M;Bertele' V;Lucca U
试验参与者和可能从研究药物中获益的患者之间的年龄差距在不同的临床领域得到了广泛的记录。临床研究中纳入的痴呆患者总体上比一般人群年轻。我们研究了最近的临床试验参与者之间的年龄差距，这些临床试验测试了阿尔茨海默病的干预措施和流行病学数据。我们系统地检索了2000年至2015年7月的文献数据库（MedLine、EMBASE、科克伦图书馆）和ClinicalTrials.gov，以检索除胆碱酯酶抑制剂和美金刚外的阿尔茨海默病药物治疗临床试验。我们纳入了正在进行和已完成的II/III期随机临床试验，无论其出版状态如何。从每个报告参与者年龄的研究中，我们提取了样本大小，平均年龄和标准差，并估计了不同年龄段参与者的比例。美国人群中按年龄分类的阿尔茨海默病患者人数用于比较。我们纳入了165项临床试验，测试了近100种不同的化合物，招募或计划招募约74，300名参与者。其中79项试验，约26，800名参与者，报告了参与者的年龄。加权平均年龄为73.6岁（标准差为8.2）。年龄小于80岁的人在临床试验中的代表性很高（78%），尽管80岁及以上的老年人占阿尔茨海默病患者的大多数（72%）。只有8%的临床试验参与者年龄在85岁或以上。参加阿尔茨海默病临床试验的患者远远不能代表患者在一般人群中的实际分布。临床研究的设计和进行不应该忽视这样一个事实，即大多数阿尔茨海默病患者可能是80岁或以上。本文的在线版本（doi：10.1186/s13195-016-0201-2）包含补充材料，可供授权用户使用。
The age gap between participants in trials and patients who could benefit from the drugs studied has been widely documented across different clinical areas. Patients with dementia included in clinical research are systematically younger than those in the general population. We examined the age gap between participants in recent clinical trials testing interventions for Alzheimer’s disease and epidemiological data. We systematically searched literature databases (MedLine, EMBASE, the Cochrane Library) and ClinicalTrials.gov from 2000 to July 2015 to retrieve clinical trials testing pharmacologic treatments for Alzheimer’s disease, other than cholinesterase inhibitors and memantine. We included ongoing and completed phase II/III randomized clinical trials, irrespective of their publication status. From each study reporting the participants’ ages, we extracted size of sample, mean age, and standard deviation, and estimated the proportions of participants in different age classes. The number of patients with Alzheimer’s disease by age class in the USA population was used for comparison. We included 165 clinical trials testing almost 100 different compounds, which enrolled or planned to enroll about 74,300 participants. Seventy-nine of these trials, accounting for about 26,800 participants, reported the age of the participants. The weighted mean age was 73.6 years (standard deviation, 8.2). People younger than 80 years were highly represented in clinical trials (78 %), despite the fact that those aged 80 and older form the majority (72 %) of patients with Alzheimer’s disease. Only 8 % of clinical trial participants were 85 years or older. Patients enrolled in clinical trials on Alzheimer’s disease are far from being representative of actual distribution of the patients in the general population. Clinical research should not be designed and conducted overlooking the fact that the majority of individuals with Alzheimer’s disease are likely to be 80 or older. The online version of this article (doi:10.1186/s13195-016-0201-2) contains supplementary material, which is available to authorized users.