Carefully watched clinical trials of potential Alzheimer’s disease medications have failed to prevent or delay cognitive decline. This is another disappointment of the long and difficult effort to find a solution to the illness.
This 10-year trial is the first time that people who are genetically destined to develop the disease but who are still asymptomatic have been given medications aimed at stopping or delaying their decline. Participants are members of Colombia’s 6,000 extended families, of whom approximately 1,200 have genetic mutations that effectively guarantee that they will develop Alzheimer’s disease in their mid-40s to mid-50s.
For many members of families living in Medellín and remote mountain villages, the disease quickly deprived them of their ability to work, communicate, and perform basic functions. Many die in their 60s.
In the study, 169 people with mutations received either placebo or the drug crenezumab. Made by Genentech, Part of the Roche Group. Another 83 people without mutations received placebo as a way to protect the identities of those who may develop the disease. This is very stigmatized in their community.
Investigators are a more common type of drug intervention that repels illness and is not caused by a single genetic mutation, many years before memory and thinking problems are expected to occur. We wanted to provide important insights for dealing with Alzheimer’s disease.
Dr. Eric Rayman, Managing Director and Research Team Leader at the Banner Alzheimer’s Institute, Phoenix’s Research and Treatment Center, said at a press conference, “I’m disappointed that crenezumab did not show significant clinical benefits. “. About the result. “Our mind is directed at the Colombian family 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 the Alzheimer’s disease prevention study. I am fascinated by the knowledge that it helps shape the new era of. “
This result is another retreat of drugs targeting amyloid, an important protein in Alzheimer’s disease. Amyloid forms amyloid plaques in the brains of patients with this disease. Years of research with different drugs that attack amyloid at different stages of the disease have leveled off. 2019, Roche Two other trials of crenezumab were discontinuedA more typical monoclonal antibody in people in the early stages of Alzheimer’s disease, states that the study is unlikely to benefit.
Last year, in a highly controversial decision, the Food and Drug Administration granted the first approval of the anti-amyloid drug Aducanumab. The FDA acknowledged that it is unclear whether aducanumab can help patients, but in the case of serious illnesses with little treatment, and the biological mechanisms by which the drug is likely to be reasonably useful. If it affects the benefits, it is approved under a program that allows the approval of uncertain medicines. Patience. The FDA stated that the biological mechanism is Aducanumab’s ability to attack amyloid, but many Alzheimer’s disease experts have criticized this decision due to its poor track record of anti-amyloid therapy. Thursday’s trial results were only added to the disappointing evidence.
Dr. Sam Gandhi, director of the Cognitive Health Center in Mount Sinai, who was not involved in the Colombian study, said:
“Pathogenic mutations in Colombian families are known to be involved in amyloid metabolism, which were considered to be the patients most likely to respond to anti-amyloid antibodies,” Dr. Gandy said. Added.
Dr. Pierre Tariot, director of the Banner Alzheimer’s Institute and leader in Colombian studies, suggests that some data suggest that patients receiving crenezumab are superior to 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 cerebral hemorrhage or swelling in some patients.
Additional exam data will be presented at the August meeting. Dr. Tariot and Dr. Rayman said Thursday’s results did not include more detailed information from brain images or blood analyzes on the effects of drugs on proteins or 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, Dr. Tariot said. He said some patients received the highest dose of up to 2 years between the 5 and 8 years they were in the clinical trial.
Dr. Francisco Lopera, a Colombian neurologist and another leader in the study, began working with his family decades ago to help determine their distress as a genetic form of Alzheimer’s disease. I did. He said the trial was convinced that “prevention is the best way to find a solution to Alzheimer’s disease, even if it doesn’t give good results today.”
“We know we have taken a big step in contributing to the investigation of Alzheimer’s disease,” he added. “And now we are ready to start another step in considering a solution to this disease.”
One participant’s wife, Maria Aliza of Medellín, said her husband, Hernando, was the first patient to enroll in the trial because her name was withheld to protect his privacy. rice field. Hernando, 45, who was involved in the repair of telephone cables, began to develop symptoms of cognitive decline about eight years ago. Since then, he has progressed to Alzheimer’s disease, but he can still continue the conversation. His deterioration was relatively slow, so his family expected him to benefit from the trial.
“I had all my hopes for this study,” his wife said.
Jenny Erin Smith contributed a report from Medellín, Colombia.
