Alzheimer's disease drug development pipeline: 2022.
Alzheimer's disease drug development pipeline: 2022.
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DOI：
10.1002/trc2.12295
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发表时间：
2022
影响因子：
4.8
通讯作者：
Taghva, Kazem
中科院分区：
文献类型：
--
作者：
Cummings, Jeffrey;Lee, Garam;Nahed, Pouyan;Kambar, Mina Esmail Zadeh Nojoo;Zhong, Kate;Fonseca, Jorge;Taghva, Kazem
阿尔茨海默病（AD）是一种全球性的健康危机。需要治疗来预防、延迟发作、减缓进展、改善认知和减少AD的行为障碍。我们回顾了目前的临床试验和药物开发的治疗AD。我们搜索了政府网站www.example.com，其中所有在美国进行的临床试验都必须注册。我们使用人工智能（AI）和机器学习（ML）方法来确保对试验和开发中的药物进行全面检测和表征。我们使用常见阿尔茨海默病研究本体（CADRO）来分类药物靶点和药物作用机制。截至2022年1月25日（本研究的索引日期），172项AD临床试验中有143种药物。该管道包括31种药物在第3阶段的47项试验中，82种药物在第2阶段的94项试验中，30种药物在第1阶段的31项试验中。疾病缓解治疗占试验药物总数的83.2%;症状性认知增强治疗占试验药物的9.8%;治疗神经精神症状的药物占6.9%。试验中的药物代表了多种药物靶标，包括几乎所有CADRO类别。37%的候选药物是被批准用于其他适应症的再用途药物。总共需要50，575名参与者才能满足所有目前正在进行的临床试验的招募要求。AD药物开发管道具有代表大量治疗机制和靶点的药物。药物设计、结果测量、生物标志物的使用和试验实施方面的进展有望加速为AD患者提供新的和更好的治疗。目前阿尔茨海默病（AD）药物开发管道中有143种药物。疾病修饰疗法占候选治疗的83.2%。目前的试验需要50，575名参与者，他们将为临床试验贡献3，878，843周的参与者。生物制药行业赞助了50%的临床试验，包括68%的3期试验。63%的3期试验和46%的2期试验包括非北美临床试验地点，表明AD药物开发所需的全球生态系统。
Alzheimer's disease (AD) represents a global health crisis. Treatments are needed to prevent, delay the onset, slow the progression, improve cognition, and reduce behavioral disturbances of AD. We review the current clinical trials and drugs in development for the treatment of AD. We searched the governmental website clinicaltrials.gov where are all clinical trials conducted in the United States must be registered. We used artificial intelligence (AI) and machine learning (ML) approaches to ensure comprehensive detection and characterization of trials and drugs in development. We use the Common Alzheimer's Disease Research Ontology (CADRO) to classify drug targets and mechanisms of action of drugs in the pipeline. As of January 25, 2022 (index date for this study) there were 143 agents in 172 clinical trials for AD. The pipeline included 31 agents in 47 trials in Phase 3, 82 agents in 94 trials in Phase 2, and 30 agents in 31 trials in Phase 1. Disease‐modifying therapies represent 83.2% of the total number of agents in trials; symptomatic cognitive enhancing treatments represent 9.8% of agents in trials; and drugs for the treatment of neuropsychiatric symptoms comprise 6.9%. There is a diverse array of drug targets represented by agents in trials including nearly all CADRO categories. Thirty‐seven percent of the candidate agents in the pipeline are repurposed drugs approved for other indications. A total of 50,575 participants are needed to fulfill recruitment requirements for all currently active clinical trials. The AD drug development pipeline has agents representing a substantial array of treatment mechanisms and targets. Advances in drug design, outcome measures, use of biomarkers, and trial conduct promise to accelerate the delivery of new and better treatments for patients with AD. There are 143 drugs in the current Alzheimer's disease (AD) drug development pipeline. Disease‐modifying therapies represent 83.2% of the candidate treatments. Current trials require 50,575 participants who will donate 3,878,843 participant‐weeks to clinical trials. The biopharmaceutical industry sponsors 50% of all clinical trials including 68% of Phase 3 trials. Sixty‐three percent of Phase 3 trials and 46% of Phase 2 trials include non–North American clinical trial site locations indicating the global ecosystem required for AD drug development.