Accelerating Alzheimer's therapeutic development: The past and future of clinical trials

被引：94

作者：

Boxer, Adam L. ^{[1
]}

Sperling, Reisa ^{[2
]}

机构：

[1] Univ Calif San Francisco, Weill Inst Neurosci, Memory & Aging Ctr, Dept Neurol, San Francisco, CA 94158 USA

[2] Harvard Med Sch, Ctr Alzheimer Res & Treatment, MassGen Brigham, Dept Neurol, Boston, MA USA

来源：

CELL | 2023年 / 186卷 / 22期

关键词：

BETA IMMUNIZATION AN1792; DISEASE; TAU; BAPINEUZUMAB; ASSOCIATION; AD;

D O I：

10.1016/j.cell.2023.09.023

中图分类号：

Q5 [生物化学]; Q7 [分子生物学];

学科分类号：

071010 ; 081704 ;

摘要：

Alzheimer's disease (AD) research has entered a new era with the recent positive phase 3 clinical trials of the anti-Ab antibodies lecanemab and donanemab. Why did it take 30 years to achieve these successes? Devel-oping potent therapies for reducing fibrillar amyloid was key, as was selection of patients at relatively early stages of disease. Biomarkers of the target pathologies, including amyloid and tau PET, and insights from past trials were also critical to the recent successes. Moving forward, the challenge will be to develop more efficacious therapies with greater efficiency. Novel trial designs, including combination therapies and umbrella and basket protocols, will accelerate clinical development. Better diversity and inclusivity of trial participants are needed, and blood-based biomarkers may help to improve access for medically under-served groups. Incentivizing innovation in both academia and industry through public-private partnerships, collaborative mechanisms, and the creation of new career paths will be critical to build momentum in these exciting times.

引用

页码：4757 / 4772

页数：16

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