Study partners should be required in preclinical Alzheimer's disease trials.
Study partners should be required in preclinical Alzheimer's disease trials.
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DOI：
10.1186/s13195-017-0327-x
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发表时间：
2017-12-06
期刊：
影响因子：
--
通讯作者：
Karlawish J
中科院分区：
文献类型：
--
作者：
Grill JD;Karlawish J
为了更早地干预阿尔茨海默病（AD），临床试验正在测试临床前疾病中有希望的候选疗法。临床前AD试验参与者认知正常，功能独立，自主决策。然而，与AD痴呆试验一样，临床前试验需要参与者和知识渊博的知情人或研究伙伴的双重登记。二元入组的要求是招募的一个障碍，可能会带来独特的道德挑战。尽管有这些限制，这项要求应继续下去。研究合作伙伴对于确保参与者的安全和福祉可能至关重要，包括克服与生物标志物披露相关的痛苦并最大限度地降低灾难性反应和自杀的风险。该要求可以最大限度地保留受试者并确保数据完整性，包括研究合作伙伴是最终指导新治疗是否具有临床获益以及对AD相关人群健康负担是否有意义影响的数据来源。最后，需要研究伙伴来确保试验的科学和临床价值。临床前AD将代表一种新的护理模式，其中没有症状的人被告知可能的认知能力下降和最终的痴呆症。早期诊断症状性AD的基本原理同样适用于临床前AD，以最大限度地降低风险，最大限度地提高生活质量，并确保最佳的计划和沟通。家庭成员和其他来源的支持可能是必不可少的目标，这种新的模式的护理临床前AD患者和试验必须指导这种临床实践。
In an effort to intervene earlier in Alzheimer’s disease (AD), clinical trials are testing promising candidate therapies in preclinical disease. Preclinical AD trial participants are cognitively normal, functionally independent, and autonomous decision-makers. Yet, like AD dementia trials, preclinical trials require dual enrollment of a participant and a knowledgeable informant, or study partner. The requirement of dyadic enrollment is a barrier to recruitment and may present unique ethical challenges. Despite these limitations, the requirement should continue. Study partners may be essential to ensure participant safety and wellbeing, including overcoming distress related to biomarker disclosure and minimizing risk for catastrophic reactions and suicide. The requirement may maximize participant retention and ensure data integrity, including that study partners are the source of data that will ultimately instruct whether a new treatment has a clinical benefit and meaningful impact on the population health burden associated with AD. Finally, study partners are needed to ensure the scientific and clinical value of trials. Preclinical AD will represent a new model of care, in which persons with no symptoms are informed of probable cognitive decline and eventual dementia. The rationale for early diagnosis in symptomatic AD is equally applicable in preclinical AD—to minimize risk, maximize quality of life, and ensure optimal planning and communication. Family members and other sources of support will likely be essential to the goals of this new model of care for preclinical AD patients and trials must instruct this clinical practice.
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影响因子：
29
作者：
Donohue, Michael C.;Sperling, Reisa A.;Salmon, David P.;Rentz, Dorene M.;Raman, Rema;Thomas, Ronald G.;Weiner, Michael;Aisen, Paul S.
通讯作者：
Aisen, Paul S.
影响因子：
9
作者：
Harkins, Kristin;Sankar, Pamela;Karlawish, Jason
通讯作者：
Karlawish, Jason
DOI：
10.1016/j.jalz.2013.02.007
发表时间：
2014-05
期刊：
Alzheimer's & dementia : the journal of the Alzheimer's Association
影响因子：
--
作者：
Gifford KA;Liu D;Lu Z;Tripodis Y;Cantwell NG;Palmisano J;Kowall N;Jefferson AL
通讯作者：
Jefferson AL
影响因子：
158.5
作者：
Green, Robert C.;Roberts, J. Scott;Farrer, Lindsay A.
通讯作者：
Farrer, Lindsay A.
影响因子：
5.2
作者：
Ashida, Sato;Koehly, Laura M.;Roberts, J. Scott;Chen, Clara A.;Hiraki, Susan;Green, Robert C.
通讯作者：
Green, Robert C.