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

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

Gantenerumab is part of a class of injected drugs that are designed to remove sticky protein fragments called beta amyloid from the brain. Amyloid beta buildup is a hallmark of Alzheimer’s disease.

Most of these drugs have worked as intended to kill amyloid beta, but many have yet to show any real benefit to patients; his brain function and memory do not improve significantly, despite treatment.

Roche said Monday that gantenerumab appears to have removed less amyloid beta from the brains of study participants than expected. The company said the 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, so it is very disappointing to deliver this news,” Dr. Levi Garraway, Roche’s chief medical officer and head of global product development, said in a statement. Press release. “While the results from GRADUATE are not what we expected, we are proud to have delivered a high-quality, clear, and comprehensive Alzheimer’s data set to the field, and we look forward to sharing our learnings with the community as we continue to seek new treatments for this complex disease.

Roche said it would share more of its study findings at an upcoming medical conference.

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

Dr. Constantine Lyketsos, a professor of psychiatry at Johns Hopkins School of Medicine, said that if gantenerumab had eliminated as much amyloid beta as the company predicted, it might have shown a similar degree of benefit as 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 the results of the Roche study are “disappointing” but remain “encouraging for this class of treatment.”

“Each anti-amyloid treatment being tested works in a different way, and research into its efficacy and safety must continue. It is important to evaluate each treatment independently,” said María Carrillo, scientific director of the nonprofit organization, in the statement.

An estimated 6.5 million Americans will be living with Alzheimer’s disease by 2022, according to the Alzheimer’s Association.