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

By Brenda Goodman, CNN

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

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

Most of these drugs have worked as intended to clear the beta amyloid, but many have still failed to demonstrate any real-life benefits to patients; their brain function and memory doesn’t improve significantly, despite treatment.

Roche said Monday that gantenerumab appears to have removed less beta amyloid from the brains of study participants than anticipated. The company said the results from Phase 3 of its trials, called Graduate, were hard but important to share.

“So many of our families have been directly affected by Alzheimer’s, so this news is very disappointing to deliver,” Dr. Levi Garraway, Roche’s chief medical officer and head of global product development, said in a news release. “While the GRADUATE results are not what we hoped, we are proud to have delivered a high quality, clear and comprehensive Alzheimer’s dataset to the field, and we look forward to sharing our learnings with the community as we continue to search for new treatments for this complex disease.”

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

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

Dr. Constantine Lyketsos, a 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 would, it might have shown a degree of benefit in line 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 the results of Roche’s study are “disappointing,” but it remains “hopeful for this class of treatment.”

“Each anti-amyloid treatment being tested acts in a different way, and research into their effectiveness and safety must continue. It is important to evaluate each treatment independently,” Maria Carrillo, the nonprofit’s chief scientific officer, said in the statement.

An estimated 6.5 million Americans are living with Alzheimer’s disease in 2022, according to the Alzheimer’s Association.

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