Alzheimer’s: a drug slowed the progression of the disease in 35 percent of cases

2023-05-04 00:45:00

Donanemab, an experimental Alzheimer’s drug developed by the pharmaceutical company Eli Lilly and Coshowed reductions in cognitive decline by 35 percent in a late-stage trial.

This was announced by the company this Wednesday, May 3, noting that the evidence suggests that the removal of amyloid plaques from the brain benefits patients with this deadly disease. The drug met all of the trial’s objectives, the company said.

The drug, they reported, slowed the progression of Alzheimer’s disease in 35% of cases –compared to those who took placebo – and those results emerged from the trial in 1,182 people with early-stage disease, whose brains had deposits of two key Alzheimer’s disease proteins, beta amyloid, as well as intermediate levels of tau, a protein related to disease progression and brain cell death.

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The study also tested the drug in 552 patients with high tau levels and found that when both arms were combined, donanemab slowed progression by 29%, saccording to a commonly used dementia progression scale known as the Clinical Dementia Rating Scale (CDR-SB).

Dr. Ronald Petersen, an Alzheimer’s researcher at the Mayo Clinic, said Lilly’s trial is the third to show that removing amyloid from the brain slows the progression of the disease, which could allay some lingering doubts about the benefits of the drugs. of that kind. “It’s modest, but I think it’s real,” he said of the drug’s effect, adding that it’s “clinically significant”as stated Reuters.

For his part, Dr. Erik Musiek, a neurologist at the University of Washington at Barnes-Jewish Hospital, said that there is already evidence that these types of drugs work and that they are effective in early treatments. “The evidence is really starting to accumulate that these drugs work,” said. And he added: “It really suggests that you need to remove these plaques early.”

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Study participants received a monthly intravenous infusion of donanemab. At 12 months, half had no evidence of amyloid plaques, the company said.

In 47% of cases, patients taking donanemab in the 18-month trial had no disease progression at 12 months, compared with 29% in the placebo group.

Pharmaceutical Lilly said brain swelling, a known side effect of such drugs, occurred in 24% of participants, with 6.1% experiencing symptoms. Brain bleeding occurred in 31.4% of cases in the donanemab group and in 13.6% in the placebo group.

As for the incidence of severe brain swelling in the study, they detailed, it was 1.6%, including two deaths attributed to the condition and a third after an incident of severe brain swelling.

Regarding the risks, Dr. Eric Reiman, executive director of the Banner Alzheimer’s Institute – which is conducting a study of donanemab in pre-symptomatic patients – considered that “there is some risk” in taking the drug, which must be taken into account when to analyze the benefits it has.

The pharmaceutical company plans to apply for traditional US approval. by the end of June, and soon after with regulators in other countries. A company spokesperson said the US approval decision should come in late 2023 or early 2024.

Lilly’s drug would become the third of its kind on the market after the approval of two similar drugs developed by other companies such as Eisai and Biogen. Both were approved under the FDA’s accelerated review program, based on their ability to remove amyloid plaques.

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