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An experimental Alzheimer's drug could be approved next year. But it comes with risks
Researchers say the experimental Alzheimer's drug Lecanemab represents an important advance and is likely to get FDA approval in 2023, despite some safety concerns.
STEVE INSKEEP, HOST:
An experimental drug is raising hope for the treatment of Alzheimer's disease, although it does come with some risks. So NPR's Jon Hamilton looked at the evidence.
JON HAMILTON, BYLINE2: The drug, called lecanemab, only slows down Alzheimer's a bit. But it dominated last week's Clinical Trials on Alzheimer's Disease meeting in San Francisco. Dr. Eric Reiman was there. He's the executive director of Banner Alzheimer's Institute in Phoenix3.
ERIC REIMAN: There was a feeling of elation4 that this was a milestone5 in the fight against Alzheimer's disease and very important.
HAMILTON: A study of nearly 1,800 people in the early stages of Alzheimer's found that lecanemab slowed down declines in memory and thinking by 27%. Reiman says that's a modest but meaningful benefit from the drug.
REIMAN: It had effects on a range of cognitive6 and functional7 measurements that are important to families and family caregivers. But clearly, a treatment by itself that is not going to stop the progression of the disease.
HAMILTON: Lecanemab contains antibodies designed to remove a substance called amyloid from the brain. That makes it similar to the controversial drug Aduhelm, which received a conditional8 approval from the Food and Drug Administration last year. The agency acted despite conflicting evidence on whether Aduhelm slows down the disease. Reiman says the results with lecanemab are much clearer.
REIMAN: I'll be surprised if it doesn't get full approval.
HAMILTON: Probably sometime next year. Both Aduhelm and lecanemab have risks, including a condition known as ARIA9. Dr. Sharon Cohen, medical director of the Toronto Memory Program in Canada, says when a brain scan shows ARIA, it's a sign of either swelling10 or bleeding.
SHARON COHEN: This sounds very dramatic to have swelling in the brain or bleeding in the brain, and of course, nobody wants that.
HAMILTON: But Cohen says even though ARIA is common, it rarely has a big impact on patients' health.
COHEN: What we've learned over time is that a very small proportion of individuals will have symptoms, and when symptoms arise, they are usually transient, mild to moderate and resolve.
HAMILTON: In rare cases, though, patients can experience brain damage or even death. Cohen says the risks of ARIA appear to be higher in people who have very high levels of amyloid in the brain or are taking blood thinners.
COHEN: There will be patients for whom this is not a good therapy.
HAMILTON: Lecanemab and other drugs that remove amyloid have another side effect that is more mysterious. They seem to cause the brain to shrink. And that concerns Dr. Madhav Thambisetty, a neurologist at the National Institute on Aging, a part of the National Institutes of Health.
MADHAV THAMBISETTY: What is a little worrying to me is that these drugs might be worsening the degenerative process that is associated with disease progression.
HAMILTON: Alzheimer's itself causes the brain to shrink, a sign that neurons are dying. So Thambisetty, whose views are independent of the NIH, expected Alzheimer's drugs to limit shrinkage rather than accelerate it.
THAMBISETTY: It's incumbent11 upon drug developers and researchers to try and prove that these changes are benign12 and do not represent a significant adverse13 event.
HAMILTON: Dr. Reisa Sperling directs the Center for Alzheimer's Research and Treatment at Brigham and Women's Hospital in Boston. She says serious side effects are common in treating other diseases like cancer.
REISA SPERLING: Alzheimer's is a terrible disease, and I think many patients and their physicians will be willing to take some risk. And our work is to minimize the risk.
HAMILTON: About 2 million Alzheimer's patients in the U.S. are potential candidates for lecanemab.
Jon Hamilton, NPR News.
1 transcript | |
n.抄本,誊本,副本,肄业证书 | |
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2 byline | |
n.署名;v.署名 | |
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3 phoenix | |
n.凤凰,长生(不死)鸟;引申为重生 | |
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4 elation | |
n.兴高采烈,洋洋得意 | |
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5 milestone | |
n.里程碑;划时代的事件 | |
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6 cognitive | |
adj.认知的,认识的,有感知的 | |
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7 functional | |
adj.为实用而设计的,具备功能的,起作用的 | |
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8 conditional | |
adj.条件的,带有条件的 | |
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9 aria | |
n.独唱曲,咏叹调 | |
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10 swelling | |
n.肿胀 | |
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11 incumbent | |
adj.成为责任的,有义务的;现任的,在职的 | |
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12 benign | |
adj.善良的,慈祥的;良性的,无危险的 | |
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13 adverse | |
adj.不利的;有害的;敌对的,不友好的 | |
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