Drug Development for Psychotropic, Cognitive-Enhancing, and Disease-Modifying Treatments for Alzheimer's Disease.
Drug Development for Psychotropic, Cognitive-Enhancing, and Disease-Modifying Treatments for Alzheimer's Disease.
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DOI：
10.1176/appi.neuropsych.20060152
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发表时间：
2021
期刊：
影响因子：
--
通讯作者：
Cummings J
中科院分区：
文献类型：
--
作者：
Cummings J
阿尔茨海默病（Alzheimer's disease，AD）是一种进行性神经退行性疾病，目前的治疗方法十分有限。在开发AD的神经精神适应症（包括激越、精神病、情感淡漠和睡眠障碍）的治疗方法方面取得了进展。候选疗法从非临床/动物评估进展到正常志愿者试验（I期）、AD小型II期试验和较大的确证性III期试验。生物标志物在选择参与者、对人群进行分层、展示靶点参与、支持疾病改良和监测安全性方面发挥着越来越重要的作用。目前有121种药物在临床试验中，包括治疗神经精神症状，认知增强和疾病进展。1期试验中有27种药物，2期试验中有65种，3期试验中有29种。试验中的大多数药物（80%）针对疾病修饰。治疗正在评估的认知正常的个人在高风险的发展为AD的二级预防试验。在目标多样化、试验设计、结局指标、生物标志物和试验人群定义方面取得了进展，有望加速为AD患者或有AD风险的患者开发新疗法。
Alzheimer’s disease (AD) is a progressive neurodegenerative disorder with limited available therapies. There is progress in developing treatments for neuropsychiatric indications including agitation, psychosis, apathy, and sleep disorders in AD. Candidate therapies progress from nonclinical/animal assessment to trials in normal volunteers (Phase 1), small Phase 2 trials in AD, and larger confirmatory Phase 3 trials. Biomarkers play an increasingly important role in selecting participants, stratifying populations, demonstrating target engagement, supporting disease modification, and monitoring safety. There are currently 121 agents in clinical trials including treatments for neuropsychiatric symptoms, cognition enhancement and, disease progression. There are 27 agents in Phase 1 trials, 65 in Phase 2 trials, and 29 in Phase 3 trials. Most of the agents in trials (80%) target disease modification. Treatments are being assessed in secondary prevention trials of cognitively normal individuals at high risk for the development of AD. There is progress in target diversification, trial designs, outcome measures, biomarkers, and trial population definitions that promise to accelerate developing new therapies for those with or at risk for AD.
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DOI：
10.3233/jad-179901
发表时间：
2018
期刊：
Journal of Alzheimer's disease : JAD
影响因子：
--
作者：
Cummings J;Ritter A;Zhong K
通讯作者：
Zhong K
影响因子：
--
作者：
Cummings J;Fox N
通讯作者：
Fox N
DOI：
10.1016/j.trci.2017.08.005
发表时间：
2017-11
期刊：
Alzheimer's & dementia (New York, N. Y.)
影响因子：
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作者：
Bertens D;Tijms BM;Vermunt L;Prins ND;Scheltens P;Visser PJ
通讯作者：
Visser PJ
DOI：
10.1007/978-3-030-05542-4_2
发表时间：
2019-01-01
期刊：
REVIEWS ON BIOMARKER STUDIES IN PSYCHIATRIC AND NEURODEGENERATIVE DISORDERS
影响因子：
--
作者：
Cummings, Jeffrey
通讯作者：
Cummings, Jeffrey
影响因子：
158.5
作者：
Anderson, Monique L.;Chiswell, Karen;Califf, Robert M.
通讯作者：
Califf, Robert M.