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[00:00.67] Another experimental Alzheimer’s drug has been shown to slow patients’ worsening conditions, researchers reported Monday.

[00:10.76] The American drug company Eli Lilly said it is seeking U.S. Food and Drug Administration (FDA) approval for the drug donanemab.

[00:22.45] If approved, it would be the second Alzheimer’s treatment for delaying the disease.

[00:29.62] Alzheimer’s affects the brain and causes memory loss and dementia.

[00:35.73] The FDA approved Leqembi, from Japanese drugmaker Eisai, earlier this month.

[00:44.76] “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.

[00:58.84] The drug does not cure the disease.

[01:01.23] Instead, it slows its progression by about four to seven months.

[01:07.08] But Sims noted that “it doesn’t mean you can’t have very meaningful treatments for patients.”

[01:14.78] Eli Lilly published the full results of its study of 1,700 patients in the Journal of the American Medical Association.

[01:25.67] It also presented its results at the Alzheimer’s conference.

[01:31.24] Both donanemab and Leqembi are laboratory-made antibodies.

[01:36.55] The treatments are injected into the patients.

[01:40.01] The drugs target a protein buildup, called beta amyloid, in the brain of Alzheimer’s patients.

[01:47.18] Both drugs come with serious safety concerns.

[01:51.43] Patients can experience brain swelling or bleeding.

[01:55.95] In the Lilly study, such side effects were linked to three deaths.

[02:02.06] Dr. Liana Apostolova was the study investigator.

[02:06.57] She is also a professor in Alzheimer's Disease research at Indiana University School of Medicine.

[02:15.07] She said, "These side effects should not be taken lightly."

[02:21.18] 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.

[02:33.14] Lilly’s study included people ages 60 to 85 who were in the early stages of Alzheimer’s.

[02:41.37] Half of the study subjects received a monthly injection of donanemab for up to 18 months.

[02:49.87] The other half received an inactive substance, called a placebo.

[02:56.24] Patients were also switched to inactive substances if enough amyloid cleared out.

[03:03.41] The study found that it happened to half of the patients within a year.

[03:08.46] Amyloid alone does not cause Alzheimer’s. So researchers also studied the levels of tau, another protein that causes the disease in the brain.

[03:19.88] Patients with higher levels of tau are considered to be in the more advanced stages of Alzheimer’s.

[03:27.86] The results: both groups declined during the 18-month study but the drug appears to work better for patients in earlier stages of the disease.

[03:40.87] Those with low to medium tau levels saw a 35- percent slower decline.

[03:48.30] For high tau patients, donanemab slowed the disease progression by about 17 percent.

[03:56.01] Anne White is the president of neuroscience at Lilly.

[04:00.79] She said, "At the end of the trial, the average patient had been without drugs for seven months and yet they continued to benefit.”

[04:10.62] Scientists say that, while these drugs may mark a new era in Alzheimer’s treatment, huge questions remain about which patients should try them.

[04:22.57] Questions also remain about how much benefit patients will really experience.

[04:29.48] The main safety concern is brain swelling or bleeding.

[04:33.99] These conditions often cause no symptoms but sometimes can be serious, even deadly.

[04:42.50] Another concern is that more than 90 percent of the study’s patients were white.

[04:49.13] 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.

[05:01.88] Lilly expects the FDA to decide by the end of this year whether to approve donanemab.

[05:09.58] The company is also seeking approval from other health agencies worldwide.