Cummings Jeffrey, Zhou Yadi, Lee Garam, Zhong Kate, Fonseca Jorge, Cheng Feixiong
Chambers-Grundy Center for Transformative Neuroscience Department of Brain Health School of Integrated Health Sciences University of Nevada, Las Vegas (UNLV) Las Vegas Nevada USA.
Genomic Medicine Institute Lerner Research Institute, Cleveland Clinic Cleveland Ohio USA.
Alzheimers Dement (N Y). 2024 Apr 24;10(2):e12465. doi: 10.1002/trc2.12465. eCollection 2024 Apr-Jun.
New therapies to prevent or delay the onset of symptoms, slow progression, or improve cognitive and behavioral symptoms of Alzheimer's disease (AD) are needed.
We interrogated clinicaltrials.gov including all clinical trials assessing pharmaceutical therapies for AD active in on January 1, 2024. We used the Common Alzheimer's Disease Research Ontology (CADRO) to classify the targets of therapies in the pipeline.
There are 164 trials assessing 127 drugs across the 2024 AD pipeline. There were 48 trials in Phase 3 testing 32 drugs, 90 trials in Phase 2 assessing 81 drugs, and 26 trials in Phase 1 testing 25 agents. Of the 164 trials, 34% ( = 56) assess disease-modifying biological agents, 41% ( = 68) test disease-modifying small molecule drugs, 10% ( = 17) evaluate cognitive enhancing agents, and 14% ( = 23) test drugs for the treatment of neuropsychiatric symptoms.
Compared to the 2023 pipeline, there are fewer trials (164 vs. 187), fewer drugs (127 vs. 141), fewer new chemical entities (88 vs. 101), and a similar number of repurposed agents (39 vs. 40).
In the 2024 Alzheimer's disease drug development pipeline, there are 164 clinical trials assessing 127 drugs.The 2024 Alzheimer's disease drug development pipeline has contracted compared to the 2023 Alzheimer pipeline with fewer trials, fewer drugs, and fewer new chemical entities.Drugs in the Alzheimer's disease drug development pipeline target a wide array of targets; the most common processes targeted include neurotransmitter receptors, inflammation, amyloid, and synaptic plasticity.The total development time for a potential Alzheimer's disease therapy to progress from nonclinical studies to FDA review is approximately 13 years.
需要新的疗法来预防或延缓阿尔茨海默病（AD）症状的出现、减缓疾病进展或改善认知和行为症状。
我们查询了clinicaltrials.gov，涵盖了2024年1月1日所有评估治疗AD药物疗法的临床试验。我们使用常见阿尔茨海默病研究本体（CADRO）对在研疗法的靶点进行分类。
在2024年AD在研项目中有164项试验评估127种药物。其中有48项3期试验测试32种药物，90项2期试验评估81种药物，26项1期试验测试25种药物。在这164项试验中，34%（=56）评估疾病修饰生物制剂，41%（=68）测试疾病修饰小分子药物，10%（=17）评估认知增强剂，14%（=23）测试治疗神经精神症状的药物。
与2023年的在研项目相比，试验数量更少（164项对187项）、药物数量更少（127种对141种）、新化学实体更少（88种对101种），且重新利用药物的数量相近（39种对40种）。
在2024年阿尔茨海默病药物研发在研项目中，有164项临床试验评估127种药物。与2023年阿尔茨海默病在研项目相比，2024年阿尔茨海默病药物研发在研项目有所收缩，试验、药物和新化学实体数量均减少。阿尔茨海默病药物研发在研项目中的药物针对多种靶点；最常见的靶向过程包括神经递质受体、炎症、淀粉样蛋白和突触可塑性。一种潜在的阿尔茨海默病疗法从非临床研究进展到FDA审评的总研发时间约为13年。
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