Medical & Scientific Relations, Alzheimer's Association, Chicago, IL, USA.
Department of Neurology, Washington University School of Medicine, St. Louis, MO, USA.
Alzheimers Dement. 2016 May;12(5):623-30. doi: 10.1016/j.jalz.2016.02.007. Epub 2016 Mar 24.
Given the complex neuropathology Alzheimer's disease (AD), combination therapy may be necessary for effective treatment. However, scientific, pragmatic, regulatory, and business challenges need to be addressed before combination therapy for AD can become a reality. Leaders from academia and industry, along with a former member of the Food and Drug Administration and the Alzheimer's Association, have explored these challenges and here propose a strategy to facilitate proof-of-concept combination therapy trials in the near future. First, a more integrated understanding of the complex pathophysiology and progression of AD is needed to identify the appropriate pathways and the disease stage to target. Once drug candidates are identified, novel clinical trial designs and selection of appropriate outcome assessments will be needed to enable definition and evaluation of the appropriate dose and dosing regimen and determination of efficacy. Success in addressing this urgent problem will only be achieved through collaboration among multiple stakeholders.
鉴于阿尔茨海默病（AD）复杂的神经病理学，可能需要联合治疗才能有效治疗。然而，在 AD 的联合治疗成为现实之前，需要解决科学、务实、监管和商业方面的挑战。来自学术界和工业界的领导人，以及前食品和药物管理局和阿尔茨海默病协会的一名成员，已经探讨了这些挑战，并在此提出了一项策略，以促进在不久的将来进行概念验证性联合治疗试验。首先，需要更深入地了解 AD 的复杂病理生理学和进展，以确定适当的途径和疾病阶段作为目标。一旦确定了候选药物，就需要新的临床试验设计和适当的结果评估选择，以确定合适的剂量和给药方案，并评估疗效。只有通过多个利益相关者之间的合作，才能成功解决这个紧迫的问题。
