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患者的研究伙伴是配偶,他们更有可能有资格参加阿尔茨海默病临床试验吗?

Are patients whose study partners are spouses more likely to be eligible for Alzheimer's disease clinical trials?

机构信息

Mary Easton Center for Alzheimer's Disease Research, Department of Neurology, UCLA David Geffen School of Medicine, Los Angeles, CA 90095, USA.

出版信息

Dement Geriatr Cogn Disord. 2012;33(5):334-40. doi: 10.1159/000339361. Epub 2012 Jul 2.

Abstract

BACKGROUND/AIMS: Alzheimer's disease (AD) clinical trials enroll two participants: a patient and a study partner. The primary caregiver most often fills the role of study partner and most trial study partners are spousal caregivers.

METHODS

AD trial inclusion criteria were applied to baseline data from 5,674 probable AD dementia research participants in the National Alzheimer's Coordinating Center Uniform Data Set. Eligibility was compared among patients with spousal, adult child, and other types of study partners.

RESULTS

Patients with spousal study partners were more frequently eligible than patients with adult child study partners. Compared to patients with spousal study partners, patients with adult child study partners were more frequently ineligible because of age, residence in skilled nursing facility, low scores on the Mini-Mental State Examination, highscores on the Hachinski Ischemia Scale, and failure to fulfill a minimum number of weekly visits with the study partner.

CONCLUSIONS

In this sample, patients with adult child study partners were less likely to qualify for AD clinical trials than were patients with spousal study partners. This may contribute to the lower representation of patients with adult child caregivers in these studies.

摘要

背景/目的:阿尔茨海默病(AD)临床试验招募了两名参与者:患者和研究伙伴。主要照顾者通常充当研究伙伴的角色,而且大多数试验的研究伙伴都是配偶照顾者。

方法

AD 试验的纳入标准适用于国家阿尔茨海默病协调中心统一数据集中 5674 名可能患有 AD 痴呆症的研究参与者的基线数据。对有配偶、成年子女和其他类型研究伙伴的患者进行了比较。

结果

有配偶研究伙伴的患者比有成年子女研究伙伴的患者更符合资格。与有配偶研究伙伴的患者相比,有成年子女研究伙伴的患者因年龄、居住在护理院、迷你精神状态检查得分低、哈钦斯基缺血量表得分高、以及未能满足每周与研究伙伴见面次数的最低要求而更不符合资格。

结论

在本样本中,有成年子女研究伙伴的患者比有配偶研究伙伴的患者更不可能符合 AD 临床试验的条件。这可能导致这些研究中成年子女照顾者的患者代表性较低。

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