Collaboration for Alzheimer's Prevention: Principles to guide data and sample sharing in preclinical Alzheimer's disease trials.
Collaboration for Alzheimer's Prevention: Principles to guide data and sample sharing in preclinical Alzheimer's disease trials.
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阿尔茨海默氏症预防合作：指导阿尔茨海默氏病试验中数据和样本共享的原则。
DOI：
10.1016/j.jalz.2016.04.001
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发表时间：
2016-05
期刊：
影响因子：
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通讯作者：
Welsh-Bohmer KA
中科院分区：
文献类型：
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作者：
Weninger S;Carrillo MC;Dunn B;Aisen PS;Bateman RJ;Kotz JD;Langbaum JB;Mills SL;Reiman EM;Sperling R;Santacruz AM;Tariot PN;Welsh-Bohmer KA
具有发展阿尔茨海默病（AD）临床症状风险的人是测试新的潜在疗法的关键人群，因为在临床发作之前有效干预疾病过程的能力可能最大。然而，在临床前AD中进行干预的最佳时机和治疗反应的敏感指标仍有待阐明。科学知识的这些差距阻碍了设计有效的临床试验的努力，这些临床试验可以快速有效地评估潜在的治疗方法。通过对疾病病理生理学的深入了解而产生的可靠生物标志物，迫切需要指导参与者招募，快速评估治疗反应，并预测长期临床结局。阿尔茨海默病预防合作组织（CAP）认识到，共享临床前AD试验的数据和生物样本对于确保通过个体试验获得的知识将使该领域整体取得进展至关重要。来自临床前AD试验的数据和样本将有助于我们了解AD的自然史;为未来试验的规模和设计提供信息;阐明生物标志物和认知测量的效用;并加速AD临床前治疗的评估。由于这些临床前试验可能会进行多年，共享新兴数据和样本
People at risk for developing the clinical symptoms of Alzheimer’s disease (AD) are a critical population for testing new potential therapeutics, as the ability to intervene effectively in the disease process may be greatest before clinical onset. However, the optimal timing for intervention and sensitive indicators of therapeutic response in preclinical AD remain to be elucidated. These gaps in scientific knowledge hinder efforts to design efficient clinical trials that can evaluate potential therapeutics rapidly and effectively. Reliable biomarkers resulting from an improved understanding of disease pathophysiology are urgently needed to guide participant enrollment, rapidly assess treatment response, and predict long-term clinical outcomes.The Collaboration for Alzheimer’s Prevention (CAP) recognizes that sharing data and biological samples from preclinical AD trials is critical to ensure that knowledge gained through individual trials will enable progress of the field as a whole. Data and samples from preclinical AD trials will help to inform our understanding of the natural history of AD; inform the size and design of future trials; clarify the utility of biomarker and cognitive measurements; and accelerate the evaluation of preclinical treatments for AD. As these preclinical trials may be conducted over many years, sharing emerging data and samples