Should EOAD patients be included in clinical trials?

Should EOAD patients be included in clinical trials?
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DOI:
10.1186/alzrt63
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发表时间:
2011-02-08
期刊:
Alzheimer's research & therapy
影响因子:
--
通讯作者:
Doody RS
Doody RS
中科院分区:
其他
文献类型:
--
作者:
Szigeti K;Doody RS

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阿尔茨海默病 (AD) 是一种毁灭性的神经退行性疾病,影响人口中六十八分之一的人。为了区分早发性 AD 和晚发性 AD,人们提出了将 65 岁作为发病年龄的任意截止点,并已在文献中使用了数十年。由于大多数患者在 65 岁后患上 AD,因此大多数临床试验都针对这一人群。虽然早发病例仅占 AD 病例的 1% 至 6%,但该人群是活跃的工作人群,因此会增加个人的公共卫生负担,而且早发病例对个人及其家庭而言最具破坏性。在这篇综述中,我们比较和对比了这两个任意群体的临床、神经心理学、影像学、遗传、生物标志物和病理特征。最后,我们讨论了不放弃和正义的伦理困境,因为它涉及将早发 AD 患者排除在临床试验之外。
Alzheimer disease (AD) is a devastating neurodegenerative disease affecting 1 in 68 in the population. An arbitrary cutoff 65 years as the age of onset to distinguish between early- and late-onset AD has been proposed and has been used in the literature for decades. As the majority of patients develop AD after 65 years of age, most clinical trials address this population. While the early-onset cases represent only 1% to 6% of AD cases, this population is the active working subset and thus contributes to a higher public health burden per individual, and early-onset cases are the most devastating at the level of the individual and their families. In this review, we compare and contrast the clinical, neuropsychological, imaging, genetic, biomarker, and pathological features of these two arbitrary groups. Finally, we discuss the ethical dilemma of non-abandonment and justice as it pertains to exclusion of the early-onset AD patients from clinical trials.
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