Stephenson Diane, Perry Dan, Bens Cynthia, Bain Lisa J, Berry Donald, Krams Michael, Sperling Reisa, Dilts David, Luthman Johan, Hanna Debra, McKew John, Temple Robert, Fields F Owen, Salloway Stephen, Katz Russell
CAMD, Critical Path Institute, Tucson, AZ 85718, USA.
Expert Rev Neurother. 2015 Jan;15(1):107-13. doi: 10.1586/14737175.2015.995168. Epub 2014 Dec 26.
It is acknowledged that progress in combined therapeutic approaches for Alzheimer's disease (AD) will require an unprecedented level of collaboration. At a meeting co-hosted by the Accelerate Cure/Treatments for Alzheimer's Disease Coalition and the Critical Path Institute, investigators from industry, academia and regulatory agencies agreed on the need for combinatorial approaches to treating AD. The need for advancing multiple targets includes recognition for novel adaptive trial designs that incorporate existing and new biomarkers to evaluate drug effects independently and in combination. A combination trial now being planned may test drugs targeting different pathogenic pathways or multiple targets along a common pathway. Collaborations and consortia-based strategies are pivotal for success and a regulatory framework is recommended for success.
人们认识到，阿尔茨海默病（AD）联合治疗方法的进展将需要前所未有的合作水平。在由加速治愈/治疗阿尔茨海默病联盟和关键路径研究所共同主办的一次会议上，来自行业、学术界和监管机构的研究人员一致认为需要采用联合方法治疗AD。推进多个靶点的需求包括认识到新型适应性试验设计的必要性，这些设计纳入现有和新的生物标志物，以独立和联合评估药物效果。目前正在计划的一项联合试验可能会测试针对不同致病途径或沿共同途径的多个靶点的药物。基于合作和联盟的策略对成功至关重要，建议建立一个监管框架以确保成功。
