United States health officials last week approved a new Alzheimer's drug. The drug, called Leqembi, is the first to slow the decline in memory by several months.
美国卫生官员上周批准了一种新型阿尔茨海默病药物。这种名为Leqembi的药物，是第一种将记忆力下降减缓几个月的药物。
The Alzheimer's Association describes Alzheimer's as a brain disease that causes a decline in memory, thinking and reasoning skills.
阿尔茨海默病协会将阿尔茨海默病描述为一种导致记忆力、思维和推理能力下降的脑部疾病。
One of the most common signs of Alzheimer's disease is forgetting recently learned information or dates and events. People with the disease have difficulty doing things that they did before. Some may struggle with joining or following a discussion.
阿尔茨海默病最常见的症状之一，是忘记最近学到的信息或日期和事件。患有这种疾病的人很难做以前做过的事情。有些人可能在加入或跟随讨论时感到困难。
The newly approved Leqembi is a long-needed new treatment for the disease.
新批准的Leqembi是该病长期需要的新疗法。
But experts warn that the drug is not a cure.
但专家警告说，这种药物并不能治愈该病。
Dr. Joy Snider is a brain doctor at Washington University in St. Louis, Missouri. She said, "This drug is not a cure. It doesn't stop people from getting worse, but it does measurably slow the progression of the disease." She added, "That might mean someone could have an extra six months to a year of being able to drive."
乔伊·斯奈德博士是密苏里州圣路易斯华盛顿大学的脑科医生。她说，“这种药物不能治病。它不能阻止人们病情恶化，但它确实可以明显减缓疾病的发展。”她补充道，“这可能意味着，人们可以多出六个月到一年的时间来开车。”
The U.S. Food and Drug Administration (FDA) approved the drug through a speedier-than-usual process. The process permits drugs to be launched based on early results.
美国食品和药物管理局(FDA)通过比通常更快的程序批准了该药物。该程序允许根据早期结果推出药物。
The drug is only for early-stage patients and requires an injection by healthcare workers every two weeks. It is not yet clear how much the drug can help people with the disease. There are also concerns about its safety.
该药物仅适用于早期患者，需要医护人员每两周注射一次。目前还不清楚这种药物能在多大程度上帮助患者。人们也担心它的安全性。
Still, "it's a landmark," said Dr. Richard Hodes, director of the National Institute on Aging. "It's not enough, but it's encouraging that there's something we can do," he added.
不过，“这是一个里程碑，”国家老龄研究所所长理查德·霍兹博士说。“虽然不能治愈，但令人鼓舞的是，我们可以做一些事情。”他补充道。
How does the new drug work?
这种新药是如何工作的?
Leqembi is made by Japan's Eisai and its U.S. partner Biogen. The drug is designed to target and clear away beta-amyloid, a substance that builds up in the brain and leads to Alzheimer's.
Leqembi由日本Eisai及其美国合作伙伴Biogen生产。该药物旨在靶向并清除β-淀粉样蛋白，这是一种在大脑中积累并导致老年痴呆症的物质。
Dr. Sam Gandy is an Alzheimer's expert at New York's Mount Sinai Hospital. He told the Associated Press that Leqembi targets a slightly different form of amyloid than other drugs that have sought to treat the disease. That might explain why Leqembi proved to be successful while many other experimental drugs have failed.
萨姆·甘迪医生是纽约西奈山医院的阿尔茨海默病专家。他告诉美联社，Leqembi靶向的淀粉样蛋白与其他寻求治疗该疾病的药物略有不同。这或许可以解释为什么Leqembi能成功，而其他许多实验药物却失败了。
In 2021, U.S. health officials approved a similar drug named Aduhelm, even though studies never proved it really helped patients. The move led to criticism after a congressional investigation.
2021，美国卫生官员批准了一种名为Aduhelm的类似药物，尽管研究从未证明它确实对患者有帮助。这一举动在国会调查后招致批评。
How effective is Leqembi?
Leqembi的效果如何?
In Eisai's 18-month study of nearly 1,800 people, Leqembi appeared to delay early-stage patients from getting worse by about five months.
在Eisai对近1800人进行的为期18个月的研究中，Leqembi似乎将早期患者病情恶化的时间推迟了约5个月。
The study measured people on an 18-point scale that follows their mental and functional abilities. People who got the drug still worsened but not as quickly as those given an inactive substance. The difference was nearly half a point on that scale by the study's end.
这项研究以18分的量表来衡量人们的心理和功能能力。服用药物的人病情仍然恶化，但不如服用非活性物质的人快。到研究结束时，这一差异在这个尺度上接近半个点。
Experts are divided over how meaningful the difference is.
专家们对差异的意义持不同意见。
Dr. Matthew Schrag is a neurology researcher at Vanderbilt University in Tennessee. He said, "Most patients won't notice the difference."
马修·施拉格博士是田纳西州范德比尔特大学的神经学研究员。他说，“大多数患者不会注意到这种差异。”
Schrag and some other researchers believe a meaningful improvement would require at least a difference of one full point on the 18-point scale.
施拉格和其他一些研究人员认为，一项有意义的改进需要在18分制上至少相差一个满分。
Others say slowing the disease early on - when people still function well - is important.
另一些人则表示，在人们仍能正常工作的情况下，及早减缓病情是很重要的。
Hodes, the director of the National Institute of Aging, said, "Several months with better cognition, what's that worth to you?"
美国国家老龄研究所所长霍兹说：“几个月的认知能力更好了，对你有什么价值?”
He added, "I think there you can get a strong argument: If I can interact with my family, be independent for months ... that's a very meaningful outcome."
他补充道，“我认为你可以得到一个有力的论据：如果我能与家人互动，保持几个月独立……这是一个非常有意义的结果。”
What are the risks?
风险是什么?
Like other amyloid-targeting medications, Leqembi can cause brain swelling or small brain bleeds. In Eisai's study, 13 percent of drug recipients had swelling, and 17 percent has small brain bleeds.
与其他淀粉样蛋白靶向药物一样，Leqembi会导致脑肿胀或小脑出血。在Eisai的研究中，13%的药物接受者有肿胀，17%的人有小量的脑出血。
The likely reason for this is that amyloid plaques usually form around nerve cells in the brain but sometimes they get inside blood vessels, too.
这可能是因为淀粉样蛋白斑块通常在大脑中的神经细胞周围形成，但有时也会进入血管。
Several Leqembi users died while taking the drug, including two people who were on blood-thinning medications. Eisai has said its Alzheimer's drug did not cause their deaths.
几名Leqembi使用者在服用药物时死亡，其中包括两名正在服用血液稀释药物的人。Eisai表示，他们的阿尔茨海默病药物并没有导致他们死亡。
But Gandy, the Alzheimer's expert, said the greatest risk of serious bleeding would be among Leqembi users who take blood thinners. Older adults commonly take blood thinners to prevent or treat strokes.
但老年痴呆症专家甘迪表示，服用血液稀释剂的Leqembi使用者最有可能发生严重出血。老年人通常服用血液稀释剂来预防或治疗中风。
Patients also may experience reactions from the drug that could include high body temperature, an upset stomach and changes in blood pressure.
患者还可能经历药物的不良反应，包括体温升高、胃部不适和血压变化。
Eisai says the drug should be available by January 23. A year's worth of treatment is expected to cost $26,500. If insurance companies cover the drug, however, most people will not have to pay anywhere near that much.
Eisai表示，这种药物应该在1月23日前上市。一年的治疗费用预计为26500美元。然而，如果保险公司承保该药物，大多数人将不必支付接近该金额的任何费用。
I'm Ashley Thompson.
阿什利·汤普森报道。
United States health officials last week approved a new Alzheimer's drug. The drug, called Leqembi, is the first to slow the decline in memory by several months.
The Alzheimer's Association describes Alzheimer's as a brain disease that causes a decline in memory, thinking and reasoning skills.
One of the most common signs of Alzheimer's disease is forgetting recently learned information or dates and events. People with the disease have difficulty doing things that they did before. Some may struggle with joining or following a discussion.
The newly approved Leqembi is a long-needed new treatment for the disease.
But experts warn that the drug is not a cure.
Dr. Joy Snider is a brain doctor at Washington University in St. Louis, Missouri. She said, "This drug is not a cure. It doesn't stop people from getting worse, but it does measurably slow the progression of the disease." She added, "That might mean someone could have an extra six months to a year of being able to drive."
The U.S. Food and Drug Administration (FDA) approved the drug through a speedier-than-usual process. The process permits drugs to be launched based on early results.
The drug is only for early-stage patients and requires an injection by healthcare workers every two weeks. It is not yet clear how much the drug can help people with the disease. There are also concerns about its safety.
Still, "it's a landmark," said Dr. Richard Hodes, director of the National Institute on Aging. "It's not enough, but it's encouraging that there's something we can do," he added.
How does the new drug work?
Leqembi is made by Japan's Eisai and its U.S. partner Biogen. The drug is designed to target and clear away beta-amyloid, a substance that builds up in the brain and leads to Alzheimer's.
Dr. Sam Gandy is an Alzheimer's expert at New York's Mount Sinai Hospital. He told the Associated Press that Leqembi targets a slightly different form of amyloid than other drugs that have sought to treat the disease. That might explain why Leqembi proved to be successful while many other experimental drugs have failed.
In 2021, U.S. health officials approved a similar drug named Aduhelm, even though studies never proved it really helped patients. The move led to criticism after a congressional investigation.
How effective is Leqembi?
In Eisai's 18-month study of nearly 1,800 people, Leqembi appeared to delay early-stage patients from getting worse by about five months.
The study measured people on an 18-point scale that follows their mental and functional abilities. People who got the drug still worsened but not as quickly as those given an inactive substance. The difference was nearly half a point on that scale by the study's end.
Experts are divided over how meaningful the difference is.
Dr. Matthew Schrag is a neurology researcher at Vanderbilt University in Tennessee. He said, "Most patients won't notice the difference."
Schrag and some other researchers believe a meaningful improvement would require at least a difference of one full point on the 18-point scale.
Others say slowing the disease early on - when people still function well - is important.
Hodes, the director of the National Institute of Aging, said, "Several months with better cognition, what's that worth to you?"
He added, "I think there you can get a strong argument: If I can interact with my family, be independent for months ... that's a very meaningful outcome."
What are the risks?
Like other amyloid-targeting medications, Leqembi can cause brain swelling or small brain bleeds. In Eisai's study, 13 percent of drug recipients had swelling, and 17 percent has small brain bleeds.
The likely reason for this is that amyloid plaques usually form around nerve cells in the brain but sometimes they get inside blood vessels, too.
Several Leqembi users died while taking the drug, including two people who were on blood-thinning medications. Eisai has said its Alzheimer's drug did not cause their deaths.
But Gandy, the Alzheimer's expert, said the greatest risk of serious bleeding would be among Leqembi users who take blood thinners. Older adults commonly take blood thinners to prevent or treat strokes.
Patients also may experience reactions from the drug that could include high body temperature, an upset stomach and changes in blood pressure.
Eisai says the drug should be available by January 23. A year's worth of treatment is expected to cost $26,500. If insurance companies cover the drug, however, most people will not have to pay anywhere near that much.
I'm Ashley Thompson.
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Words in This Story
decline - n. the process of become worse in condition
landmark - n. a very important achievement
encourage - v. to make something more likely to happen
scale - n. a range of numbers that is used to show size, quality or strength
cognition - n. the activity of thinking, understanding, learning and remembering
interact - v. to talk or do things with other people
outcome - n. something that happens as a result of activity or progress
swelling - n. an area on someone body's that is larger than normal because of an illness or injury
plaque - n. a change in brain tissue that happens in Alzheimer's disease
stroke - n. a serious illness caused when a blood vessel in your brain suddenly breaks or is blocked
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