Experimental gantenerumab therapy fails to slow or improve Alzheimer’s memory loss in clinical trials



CNN

An experimental treatment, gantenerumab, failed to help people at high risk of Alzheimer’s disease-related memory loss or those in the early stages of the disease, the manufacturer said Monday.

Gantenerumab is part of a class of injected drugs designed to remove bits of sticky proteins called beta-amyloid from the brain. Beta-amyloid buildup is a hallmark of Alzheimer’s disease.

Most of these drugs worked as expected to remove beta-amyloid, but many still failed to demonstrate real benefit to patients; their brain function and memory do not improve significantly, despite treatment.

Roche said Monday that gantenerumab appears to have removed less beta-amyloid from study participants’ brains than expected. The company said results from phase 3 of its trials, called Graduate, were difficult but important to share.

“Many of our families have been directly affected by Alzheimer’s disease, so this news is very disappointing,” said Dr. Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development, in a press release. . “Although the results from GRADUATE were not what we had hoped, we are proud to have provided a high quality, clear and comprehensive dataset on Alzheimer’s disease, and we look forward to sharing our learnings with the community. community as we continue to search for new treatments for this complex disease.

Roche said it will share more results from its study at an upcoming medical conference.

The gantenerumab results follow positive results from another beta-amyloid-lowering drug, lecanemab. The companies testing the drug, Biogen and Eisai, announced this year that lecanemab slowed the decline of brain function in Alzheimer’s disease by about 27% compared to a placebo. Some experts believe the degree of benefit is comparable to that of the controversial Alzheimer’s drug Aduhelm, which was approved by the US Food and Drug Administration despite lack of support from the agency’s independent advisers.

Dr. Constantine Lyketsos, professor of psychiatry at the Johns Hopkins School of Medicine, said that if gantenerumab had removed as much beta-amyloid as the company predicted, it might have shown a degree of benefit consistent with lecanemab and Aduhelm.

“In other words, a very modest but not clinically significant effect,” said Lyketsos, who was not involved in the research.

The Alzheimer’s Association said in a statement that Roche’s study results are “disappointing” but remain “optimal for this class of treatment.”

“Each anti-amyloid treatment tested works differently, and research into their effectiveness and safety needs to continue. It is important to evaluate each treatment independently,” said Maria Carrillo, scientific director of the association, in the press release.

According to the Alzheimer’s Association, approximately 6.5 million Americans are living with Alzheimer’s disease in 2022.

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