Roche has added another phase 3 trial in its programme for Alzheimer's disease candidate trontinemab and will now test the drug in preclinical-stage patients at elevated risk of cognitive decline.

罗氏在其阿尔茨海默病候选药物 trontinemab 的项目中增加了另一项 3 期试验，现在将测试该药物在认知能力下降高风险的临床前阶段患者中的效果。

The new study will run alongside two earlier-announced trials in early symptomatic Alzheimer's – TRONTIER 1 and 2 – which are due to start later this year. The design of the new preclinical study hasn't been revealed yet, but it will have the goal of potentially delaying or preventing the progression of the disease to symptomatic stages..

这项新的研究将与之前宣布的两项针对早期症状性阿尔茨海默病的试验——TRONTIER 1 和 TRONTIER 2——同时进行，这两项试验预计在今年晚些时候开始。这项新的临床前研究的设计尚未公布，但其目标是可能延缓或预防疾病进展到症状阶段。

At the ongoing Alzheimer's Association International Conference (AAIC) in Toronto, Canada, Roche presented new data from a phase 1b/2a trial of

在加拿大多伦多举行的正在进行的阿尔茨海默病协会国际会议（AAIC）上，罗氏公布了来自一项1b/2a期试验的新数据。

trontinemab

特立尼单抗

which showed that it reduced amyloid levels below the 24 centiloid threshold – a commonly used cutoff point used to predict whether a patient is likely to go on to develop

结果显示，它将淀粉样蛋白水平降低到了24厘阈值以下——这一常用临界点用于预测患者是否可能继续发展为

Alzheimer's dementia

阿尔茨海默病痴呆

– in 92% of participants after 28 weeks at a dose of 3.6mg/kg.

– 在28周后，92%的参与者在剂量为3.6mg/kg时。

Moreover, 72% achieved deep clearance below 11 centiloids, often used to identify individuals who may be in the early stages of amyloid accumulation, according to Roche, which also said treatment was associated with a low (less than 5%) rate of a brain swelling side effect of amyloid-targeting drugs known as ARIA-E..

此外，罗氏公司表示，72%的患者达到了低于11厘贝的深度清除率，这一指标常用于识别可能处于淀粉样蛋白积累早期阶段的个体。该公司还表示，治疗伴随一种称为ARIA-E的淀粉样蛋白靶向药物脑肿胀副作用的发生率较低（不到5%）。

New data show that the reductions in amyloid were also accompanied by falls in other Alzheimer's biomarkers, including total tau, phosphorylated Tau (pTau)181, pTau217, and neurogranin measured in CSF and plasma.

新数据显示，淀粉样蛋白的减少还伴随着其他阿尔茨海默病生物标志物的下降，包括脑脊液和血浆中测量的总tau、磷酸化tau（pTau）181、pTau217和神经颗粒素。

Trontinemab has emerged from Roche's Brainshuttle antibody engineering platform, which adds a 'side chain' to antibodies that binds to receptors on the blood-brain barrier (BBB) – designed to protect the brain from toxins and pathogens – and allows them to make it into the central nervous system.

Trontinemab 源自罗氏的 Brainshuttle 抗体工程平台，该平台为抗体添加了一条“侧链”，能够与血脑屏障（BBB）上的受体结合——旨在保护大脑免受毒素和病原体侵害——并使其进入中枢神经系统。

The company is hoping that it will offer an improved clinical profile compared to the two approved anti-amyloid drugs for Alzheimer's, Eisai/Biogen's Leqembi (lecanemab) and Eli Lilly's Kisunla (donanemab), which have started rolling out into the market.

公司希望，与已获批准的两种阿尔茨海默病抗淀粉样蛋白药物——卫材/渤健的Leqembi（lecanemab）和礼来公司的Kisunla（donanemab）相比，它将提供更好的临床效果。这两种药物已开始进入市场。

It is estimated that less than 1% of some anti-amyloid antibodies end up in the CNS, where they can exert their activity, but Roche has estimated that it can improve that by 50 times or more with its Brainshuttle antibody.

据估计，一些抗淀粉样蛋白抗体中只有不到1%最终进入中枢神经系统（CNS），在那里它们可以发挥作用，但罗氏估计，通过其Brainshuttle抗体，可以将这一比例提高50倍或更多。

The company has also started a pre-screening study called TRAVELLER that will endeavour to select patients for its trials based on a brief clinical assessment and a positive result using its

该公司还启动了一项名为“旅行者”的预筛查研究，该研究将努力根据短暂的临床评估和使用其产品的阳性结果来选择试验患者。

Elecsys pTau217

Elecsys pTau217

blood test rather than a PET scan.

血液检查而不是PET扫描。

The company said that could 'enable broader community outreach and extend access to these trials to more diverse populations representative of Alzheimer's disease.'

该公司表示，这可以“扩大社区推广范围，并将这些试验的参与机会扩展到更能代表阿尔茨海默病的多样化人群。”