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'Best ever' Alzheimer’s drug can slow disease by a third
The best ever drug for Alzheimer's disease has been found to slow decline by a third, in a breakthrough that ushers in a new era of treatment for dementia.
On Wednesday, US pharmaceutical giant Eli Lilly announced that its drug donanemab delays the worsening of symptoms by 35 per cent.
In half of patients, the drug completely halted mental decline for more than a year.
Experts described the results as “remarkable”.
British scientists hailed the trial results as “hugely exciting”, while the Alzheimer’s Society said the drug signaled “the beginning of the end of Alzheimer’s disease”.
“This result confirms that we are now entering the treatment era of Alzheimer's disease,” said Dr Cath Mummery, consultant neurologist at University College London Hospitals NHS Foundation Trust.
“The decades-long battle to find treatments that change Alzheimer’s disease is changing.
“We are now entering the time of disease modification, where we might realistically hope to treat and maintain someone with Alzheimer's disease, with long-term disease management, rather than palliative and supportive care.”
Trial results 'dispel doubts'
Current drugs for dementia work by boosting chemical signals in the brain or treating symptoms such as insomnia or depression, but cannot stop the progression.
Use on the NHS is likely to be a long way off as the new treatment, which is administered once a month by infusion, would first need to be approved for safety by the Medicines Healthcare and Products Regulatory Agency (MHRA).
The National Institute for Health and Care Excellence (Nice) would also need to approve it for cost-effectiveness. The process of these approvals can take years.
There are 944,000 people living with dementia in Britain, with the majority suffering from Alzheimer’s. The number is expected to increase to more than one million by 2030, with one in three people born in the UK this year expected to develop dementia in their lifetime.
The condition costs the country £34.7 billion annually and is now the leading cause of death.
It is the second Alzheimer’s drug to prove successful in the past year after Eisai/Biogen’s lecanemab was shown to slow decline by 27 per cent.
Donanemab works by clearing the brain of sticky amyloid plaques that prevent brain cells from communicating.
In recent years, scientists have doubted whether removing amyloid was the correct strategy, after the failure of several trials of drugs to break up the plaques.
John Hardy, professor of Neuroscience at University College London (UCL) said the trial results should “dispel any lingering doubts” that the way to treat Alzheimer’s was to remove amyloid from the brain.
The new study involved 1,182 patients with early Alzheimer’s disease, including mild cognitive impairment, who were given monthly infusions of donanemab.
As well as postponing a worsening of clinical symptoms, the drug also allowed patients to continue to perform daily activities for longer, such as shopping, housekeeping, managing their finances and taking medication.
The study also enrolled 552 people who were at a later stage of Alzheimer’s. Results showed the drug slowed down disease progression by up to 29 per cent.
However, researchers warned that the drugs did carry some troubling side effects, such as brain swelling and bleeding. One in four trial participants suffered swelling or bleeding, and three people died from the side effects.
Eli Lilly said it would apply to the US Food and Drug Administration (FDA) for approval this quarter and “will proceed with global regulatory submissions as quickly as possible”.
British experts called on the UK regulators to quickly licence the new therapies and said the NHS should get ready to administer the treatments.
Lecanemab received FDA approval in January but has yet to be granted MHRA approval.
Dr Richard Oakley, associate director of research at the Alzheimer’s Society, said: “We need decisions as quickly as possible from the regulators MHRA and Nice.
“But that’s not the end of the story - we can’t end up in a situation where there are new drugs being approved but people can’t get access to them early in their dementia journey when they work best.
“We need more accurate, earlier dementia diagnosis in the NHS.”
Dementia experts also warned that services were already struggling to diagnose patients and could not shoulder the burden of sophisticated new therapies.
Dr Tom Russ, director of the Alzheimer Scotland Dementia Research Centre at the University of Edinburgh, added: “While this is another encouraging development, the UK NHS is not ready to implement an infusion-based therapy such as donanemab or lecanemab should they become licensed treatments in the UK.
“There needs to be significant support for struggling dementia assessment services which are still emerging from the Covid-19 pandemic to continue to diagnose, treat, and support people currently presenting while developing new ways to implement the disease-modifying treatments of the (near) future.”
注释：
usher: v; n
1. v表示" 引导；引入"，means " act as an usher"，如：I will ask Mary to usher you out.我会让玛丽把你领出去的。
2. n表示" 带位员;招待员"，means "person who shows people to their seats in theatres,etc"，如：The usher conducted us to our seats. 领位员带我们到座位上。
infusion: n
表示" 注入；灌输"，means "the process of extracting certain active properties (as a drug from a plant) by steeping or soaking (usually in water)"，如：An infusion of capital bolsters their solid brands. 注入的资本增强了其坚实的品牌。
amyloid: n; adj
表示"淀粉体"，means "a non-nitrogenous food substance consisting chiefly of starch; any substance resembling starch; resembling starch"，如：Amyloid beta is a shape-changing chameleon. 淀粉状蛋白是一种形状经常改变的蛋白。
plaque: n
1.表示"[医]齿菌斑"，means "(pathology) a small abnormal patch on or inside the body"，如：Scientists have found a compound in the fruit can stop bacteria from clinging to the teeth, blocking the formation of damaging plaque deposits.科学家在这种水果中发现一种化合物，可以阻止细菌黏附在牙齿上，防止破坏性齿菌斑沉淀物的形成。
2. 表示"匾"，means "a memorial made of brass"，如：A bronze plaque marks the house where the poet was born. 一块铜匾标示出诗人诞生的那所房子。
dispel: v
表示" 驱散；消除"，means "force to go away; used both with concrete and metaphoric meanings"，如：It is the task of a fighter to dispel darkness. 驱散黑暗，这是战士的任务。
lingering: adj
表示"拖延的；逗留不去的；"，means "the act of tarrying"，如：The lingering illness crumpled him. 长年生病把他的身体弄垮了。
中文简要说明：
阿兹海默症是失智症中最常见的一种，几十年来，医学界积极寻找治疗方式，近日美国跨国制药巨头礼来（Eli Lilly）宣布，该公司研发的新药「多纳单抗」（donanemab）可以有效减缓1/3衰退程度，堪称是有史以来最大突破。
综合英国广播公司（BBC）、《每日电讯报》报道，礼来公司公布的临床试验数据显示，新药「多纳单抗」可大幅减缓阿兹海默症患者心智退化速度。与未接受治疗的患者相比，注射「多纳单抗」患者心智退化的速度减缓29%～35%，且半数患者完全停止退化「达一年以上」。
这是近一年来第二度出现阿兹海默症新药。另一款「仑卡奈单抗」（Lecanemab）在去年11月发表，患者使用后，认知功能退化程度推迟了27%。
报道指出，多纳单抗以抗体（antibody）的形式发挥作用，透过每月注射一次，可有效清除患者脑部堆积的类淀粉蛋白斑块（amyloid plaques），推迟疾病恶化，让患者更能自主生活，像是与人沟通、开车或进行休闲嗜好。
英国失智症协会（Alzheimer's Society）形容，多纳单抗标志着阿兹海默症「结束的开始」。英国国家神经病学专家玛莫瑞（Cath Mummery）说，试验结果证实「我们正在进入治疗阿兹海默症的时代」。
不过试验也出现脑肿胀和出血的风险，有3名参与者死于相关副作用。
布里斯托大学神经学家库萨德博士（Liz Coulthard）表示，尽管多纳单抗有明显副作用，且缺乏长期数据支持，但它可帮助病患「长期与阿兹海默症共存」。
礼来公司预计将在未来几个月向美国FDA提出申请，开放医疗院所使用多纳单抗。
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