英国NHS信托机构正在主导一项名为PrevenTRON的国际临床试验,以测试罗氏制药开发的实验性药物Trontinemab是否能在痴呆症状出现前预防阿尔茨海默病的发展1。该试验将招募约1600名年龄在55至80岁之间、来自世界各地但无记忆问题的高风险人群,首批欧洲参与者将于周一接受筛查1。
试验采用血液检测方式识别高风险患者,通过检测p-tau217生物标志物来甄别对象1。研究发现,p-tau217水平最高的患者在10年内发展认知障碍的风险约为78%,血液检测p-tau217可以高达95%的准确度识别阿尔茨海默病1。参与者将被随机分配接受Trontinemab或安慰剂,试验预计持续4至6年1。
Trontinemab通过清除脑内淀粉样蛋白斑块发挥作用,早期研究表明该药物在28周内可清除9成早期患者或轻度认知衰退患者的淀粉样蛋白斑块1。由Surrey and Borders Partnership NHS foundation trust进行协调的这项试验意在在症状出现前进行干预,英国至少15家医院和诊所预计到年底参与该研究1。阿尔茨海默病影响约1/14的65岁以上人群和1/6的80岁以上人群1。
An international clinical trial called PrevenTRON is being led by UK NHS trusts to test whether an experimental drug can prevent Alzheimer's disease before symptoms emerge 1. The study will recruit approximately 1,600 people aged 55 to 80 from around the world who currently have no memory problems but are at high risk for the disease 1. Screening of the first European participants is set to begin on Monday, conducted by Surrey and Borders Partnership NHS Foundation Trust 1.
The trial centers on Trontinemab, an experimental medication developed by Roche Pharmaceuticals that works by clearing amyloid plaques from the brain 1. Early research has shown the drug can remove amyloid plaques in approximately 90 percent of early-stage patients or those with mild cognitive decline within 28 weeks 1. Participant selection will rely on blood tests measuring p-tau217 biomarkers to identify individuals at highest risk; those with the highest p-tau217 levels face roughly a 78 percent risk of developing cognitive impairment within 10 years, and blood tests can identify Alzheimer's disease with up to 95 percent accuracy using this marker 1.
Participants will be randomly assigned to receive either Trontinemab or a placebo, with the trial expected to run for four to six years 1. At least 15 hospitals and clinics across the UK are projected to participate by the end of the year 1. The trial comes as Alzheimer's disease affects approximately one in 14 people aged 65 and older, and one in six people aged 80 and older 1.
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