Another Alzheimer's Drug Showing Promise
2023-07-18
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1Another experimental Alzheimer's drug has been shown to slow patients' worsening conditions, researchers reported Monday.
2The American drug company Eli Lilly said it is seeking U.S. Food and Drug Administration (FDA) approval for the drug donanemab.
3If approved, it would be the second Alzheimer's treatment for delaying the disease.
4Alzheimer's affects the brain and causes memory loss and dementia.
5The FDA approved Leqembi, from Japanese drugmaker Eisai, earlier this month.
6"Finally there's some hope, right, that we can talk about,"
7Lilly's Dr. John Sims told reporters Monday at the Alzheimer's Association International Conference in Amsterdam, the Netherlands.
8The drug does not cure the disease.
9Instead, it slows its progression by about four to seven months.
10But Sims noted that "it doesn't mean you can't have very meaningful treatments for patients."
11Eli Lilly published the full results of its study of 1,700 patients in the Journal of the American Medical Association.
12It also presented its results at the Alzheimer's conference.
13Both donanemab and Leqembi are laboratory-made antibodies.
14The treatments are injected into the patients.
15The drugs target a protein buildup, called beta amyloid, in the brain of Alzheimer's patients.
16Both drugs come with serious safety concerns.
17Patients can experience brain swelling or bleeding.
18In the Lilly study, such side effects were linked to three deaths.
19Dr. Liana Apostolova was the study investigator.
20She is also a professor in Alzheimer's Disease research at Indiana University School of Medicine.
21She said, "These side effects should not be taken lightly."
22But she added that, in most cases, the effects were well controlled by monitoring with magnetic resonance imaging (MRI) or by stopping using the drug.
23Lilly's study included people ages 60 to 85 who were in the early stages of Alzheimer's.
24Half of the study subjects received a monthly injection of donanemab for up to 18 months.
25The other half received an inactive substance, called a placebo.
26Patients were also switched to inactive substances if enough amyloid cleared out.
27The study found that it happened to half of the patients within a year.
28Amyloid alone does not cause Alzheimer's.
29So researchers also studied the levels of tau, another protein that causes the disease in the brain.
30Patients with higher levels of tau are considered to be in the more advanced stages of Alzheimer's.
31The results: both groups declined during the 18-month study but the drug appears to work better for patients in earlier stages of the disease.
32Those with low to medium tau levels saw a 35- percent slower decline.
33For high tau patients, donanemab slowed the disease progression by about 17 percent.
34Anne White is the president of neuroscience at Lilly.
35She said, "At the end of the trial, the average patient had been without drugs for seven months and yet they continued to benefit."
36Scientists say that, while these drugs may mark a new era in Alzheimer's treatment, huge questions remain about which patients should try them.
37Questions also remain about how much benefit patients will really experience.
38The main safety concern is brain swelling or bleeding.
39These conditions often cause no symptoms but sometimes can be serious, even deadly.
40Another concern is that more than 90 percent of the study's patients were white.
41That means there is little data on how effective the treatment could be for other populations, said Alzheimer's specialist Jennifer Manly of Columbia University.
42Lilly expects the FDA to decide by the end of this year whether to approve donanemab.
43The company is also seeking approval from other health agencies worldwide.
44I'm Jill Robbins.
1Another experimental Alzheimer's drug has been shown to slow patients' worsening conditions, researchers reported Monday. 2The American drug company Eli Lilly said it is seeking U.S. Food and Drug Administration (FDA) approval for the drug donanemab. If approved, it would be the second Alzheimer's treatment for delaying the disease. Alzheimer's affects the brain and causes memory loss and dementia. 3The FDA approved Leqembi, from Japanese drugmaker Eisai, earlier this month. 4"Finally there's some hope, right, that we can talk about," Lilly's Dr. John Sims told reporters Monday at the Alzheimer's Association International Conference in Amsterdam, the Netherlands. 5The drug does not cure the disease. Instead, it slows its progression by about four to seven months. But Sims noted that "it doesn't mean you can't have very meaningful treatments for patients." 6Eli Lilly published the full results of its study of 1,700 patients in the Journal of the American Medical Association. It also presented its results at the Alzheimer's conference. 7Both donanemab and Leqembi are laboratory-made antibodies. The treatments are injected into the patients. The drugs target a protein buildup, called beta amyloid, in the brain of Alzheimer's patients. 8Both drugs come with serious safety concerns. Patients can experience brain swelling or bleeding. In the Lilly study, such side effects were linked to three deaths. 9Dr. Liana Apostolova was the study investigator. She is also a professor in Alzheimer's Disease research at Indiana University School of Medicine. She said, "These side effects should not be taken lightly." But she added that, in most cases, the effects were well controlled by monitoring with magnetic resonance imaging (MRI) or by stopping using the drug. 10The Eli Lilly study 11Lilly's study included people ages 60 to 85 who were in the early stages of Alzheimer's. Half of the study subjects received a monthly injection of donanemab for up to 18 months. The other half received an inactive substance, called a placebo. 12Patients were also switched to inactive substances if enough amyloid cleared out. The study found that it happened to half of the patients within a year. 13Amyloid alone does not cause Alzheimer's. So researchers also studied the levels of tau, another protein that causes the disease in the brain. Patients with higher levels of tau are considered to be in the more advanced stages of Alzheimer's. 14The results: both groups declined during the 18-month study but the drug appears to work better for patients in earlier stages of the disease. Those with low to medium tau levels saw a 35- percent slower decline. For high tau patients, donanemab slowed the disease progression by about 17 percent. 15Anne White is the president of neuroscience at Lilly. She said, "At the end of the trial, the average patient had been without drugs for seven months and yet they continued to benefit." 16Scientists say that, while these drugs may mark a new era in Alzheimer's treatment, huge questions remain about which patients should try them. Questions also remain about how much benefit patients will really experience. 17The main safety concern is brain swelling or bleeding. These conditions often cause no symptoms but sometimes can be serious, even deadly. 18Another concern is that more than 90 percent of the study's patients were white. That means there is little data on how effective the treatment could be for other populations, said Alzheimer's specialist Jennifer Manly of Columbia University. 19Lilly expects the FDA to decide by the end of this year whether to approve donanemab. The company is also seeking approval from other health agencies worldwide. 20I'm Jill Robbins. 21Hai Do adapted this story for Learning English based on reporting by The Associated Press and Reuters. 22_____________________________________________________ 23Words in This Story 24dementia - n. a mental illness that causes someone to be unable to think clearly 25stage - n. a particular point or period in the development of something 26decline - v. to become worse in condition 27benefit - v. to be helped