New Alzheimer’s disease drug trials have disappointing results

Thorough clinical trials of potential Alzheimer’s disease medications have failed to prevent or delay the decline in cognitive function, but were further disappointed by the long and difficult finding a solution to the disease.

The last 10-year study has given people who have a genetic predisposition to develop the disease but who have not yet shown symptoms a drug designed to stop or delay the decline in brain function. It was my first time.

Participants are members of Colombia’s 6,000 extended family, of which approximately 1,200 have genetic mutations that effectively determine the development of Alzheimer’s disease between the ages of 40 and 50.

For many families living in Medellín and remote mountain villages, the illness quickly deprived them of their ability to perform their jobs, communications and basic functions. Many died in their 60s.

In this study, 169 people with genetic mutations received either placebo or crenezumab manufactured by Genentech, a member of the Roche Group. Another 83 unmutated individuals were given placebo as a way to protect the identities of those who may develop the disease, which is highly stigmatized in their communities.

Researchers are trying to control the disease by intervening drugs years before memory and thinking problems appear, and to address the most common type of Alzheimer’s disease that is not caused by a single genetic mutation. I wanted to be able to provide important information about.

In an interview, Eric Rayman, managing director and research team leader at the Banner Alzheimer’s Institute, a research and treatment center in Phoenix, Arizona, said, “I’m disappointed that crenezumab didn’t bring significant clinical benefits. I have. ” result.

“Our mind is aimed at Colombian families and everyone else who will benefit from effective Alzheimer’s disease prophylaxis as soon as possible. At the same time, this study has begun and has helped shape a new era. I’m excited to know that I’m doing research to prevent Alzheimer’s disease. “

This result is another retreat of drugs targeting the amyloid protein, a key component of the disease. Amyloid proteins form sticky plaques in the patient’s brain. Years of research on various drugs that attack amyloid at various stages of the disease have collapsed.

In 2019, Roche discontinued two other trials of the monoclonal antibody crenezumab in people in the more typical early stages of Alzheimer’s disease.

Last year, in a highly controversial decision, the US Food and Drug Administration (FDA) granted the first approval of the anti-amyloid drug aducanumab.

The FDA has admitted that it is unclear whether aducanumab can help patients, but if they are in a serious condition with little treatment and the drug has a reasonable probability of affecting biological mechanisms. , Gave a green light to a program that allows approval of drugs with uncertain profits. To help the patient.

The agency said the biological mechanism was the ability of aducanumab to attack amyloid, but many Alzheimer’s disease experts criticized this decision due to its poor track record of anti-amyloid therapy. The results of the study, published Thursday, only added to the disappointing evidence.

“I wish I had something more positive,” he said. Sam Gandhi, director of the Cognitive Health Center on Mount Sinai, who was not involved in the study in Colombia.

“Pathogenic mutations in Colombian families are known to be involved in amyloid metabolism,” Gandhi added, “these were the beliefs that these are the patients most likely to respond to anti-amyloid antibodies.” I added.

doctor. Pierre Tariot, director of the Banner Alzheimer’s Institute and leader in Colombian studies, suggests that some data showed that patients receiving crenezumab were better than those receiving placebo. But the difference was not statistically significant.

He also said that the drug had no safety issues, as many anti-amyloid therapies, including aducanumab, caused bleeding and cerebral edema in some patients.

Additional data from the study will be presented at the August meeting. Tariot and Reiman pointed out that the latest results do not include more detailed information from brain scans and blood tests on the effects of drugs on proteins and other aspects of Alzheimer’s disease biology.

They also did not reflect an increase in the dose of crenezumab. Crenezumab began to be given to patients by researchers as they learned more about medicines, Tariot said. He said some patients received the highest doses during the two of the five to eight years they participated in the clinical trial.

doctor. Francisco Lopera, a Colombian neurologist and another research leader, began working with his family decades ago to help determine that their illness is a genetic form of Alzheimer’s disease. I did. He said the study was convinced that “prevention is the best way to find a solution to Alzheimer’s disease today, even if good results are not obtained.”

Translated by Luis Robert M. Gonzalves

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