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A closely watched clinical trial of a potential Alzheimer’s drug failed to prevent or slow cognitive decline; this was another disappointment in the long and arduous efforts to find a solution to the disease.
this ten year trial It is the first time that a drug intended to stop or delay decline has been given to people who are genetically destined to contract the disease – but who do not yet have any symptoms. Participants members of a large family About 1,200 out of 6,000 people in Colombia A genetic mutation that almost guarantees they will develop Alzheimer’s mid 40s to mid 50s.
For many members of the family living in Medellin and in remote mountain villages, illness quickly robbed them of their ability to work, communicate and perform basic functions. Many die in their 60s.
In the trial, 169 people with the mutation received either a placebo or the drug, crenezumab. Produced by Genentechis part of the Roche Group. A further 83 non-mutated subjects took a placebo as a way of preserving the identities of those likely to get the disease, which is highly stigmatized in their community.
Trial researchers had hoped that intervening with a drug years before memory and thinking problems were expected to arise could keep the disease at bay and provide important insights to address the more common type of Alzheimer’s that is not driven by a single genetic mutation.
D., executive director of the Banner Alzheimer’s Institute, a research and treatment center in Phoenix, and leader of the research team. “We are disappointed that crenezumab has not shown any significant clinical benefit,” Eric Reiman said at a press conference. about the results. “Our hearts go out to the families in Colombia and everyone else who will benefit from an effective Alzheimer’s prevention treatment as soon as possible. At the same time, we strongly believe in the knowledge that this work started and continues to help shape a new era in Alzheimer’s prevention research.”
The results are also another setback for drugs that target an important protein in Alzheimer’s: amyloid, which forms sticky plaques in the brains of patients with the disease. Years of work with various drugs that attack amyloid at different stages of the disease have been futile. Roche in 2019 stopped two other crenezumab trialsA monoclonal antibody, said studies are unlikely to show benefit in people in the early stages of more typical Alzheimer’s disease.
high last year controversial decisionThe Food and Drug Administration has granted the first approval of Aduhelm, an anti-amyloid drug. The FDA acknowledged it was unclear whether Aduhelm could help patients, but gave the green light under a program that allows authorization of drugs with uncertain benefits if it is for serious illness with few treatments and if the drugs affect a biological mechanism that is reasonably likely to help. patients. The FDA said the biological mechanism was Aduhelm’s ability to attack amyloid, but many Alzheimer’s experts criticized the decision because of the poor track record of anti-amyloid treatments. Thursday’s trial results only added to the disappointing evidence.
D., director of Mount Sinai’s Center for Cognitive Health and not involved in the Colombian research. “I wish there was something more positive to say,” said Sam Gandy.
Dr. “The pathogenic mutation in the Colombian family is known to be involved in amyloid metabolism,” said Gandy, adding, “The thought was that these were the patients most likely to respond to anti-amyloid antibodies.”
Director of the Banner Alzheimer’s Institute and leader of the Colombian study, Dr. Pierre Tariot said some data show that patients who took crenezumab did better than those who took a placebo, but the differences were not statistically significant.
He also said there were no safety issues with the drug, which is an important finding because many anti-amyloid treatments, including Aduhelmhas caused cerebral haemorrhage or swelling in some patients.
Additional data from the trial will be presented at a conference in August. Dr. Tariot and Dr. Reiman noted that Thursday’s results contained no more detailed information than neuroimaging or blood analysis on the drug’s effects on proteins and other aspects of Alzheimer’s biology. Dr. Nor did it reflect the increases in the dose of crenezumab that researchers began giving patients as they learned more about the drug, Tariot said. He said some patients took the highest dose for up to two years during the five to eight years they were in the clinical trial.
Dr. Francisco Lopera, a Colombian neurologist and another leader of the study began working with family members decades ago and helped determine that their condition was a genetic form of Alzheimer’s. He said the trial convinced him that “even if we don’t get good results today, the best way to look for a solution to Alzheimer’s disease is prevention.”
“We know we’ve taken a big step forward in contributing to the study of Alzheimer’s disease,” he said. “And now we’re ready to take further steps to look at the resolution of this disease.”
Maria Areiza of Medellin, wife of one participant, said her husband Hernando, whose surname was kept confidential, was among the first patients to participate in the study. Hernando, 45, who works to repair telephone wires, began developing symptoms of cognitive decline about eight years ago. She has since switched to Alzheimer’s dementia, but can still make a speech. Because his deterioration was relatively slow, his family was hopeful that he was benefiting from the lawsuit.
“I had pinned all my hopes on this work,” his wife said.
Jennie Erin Smith contributed news from Medellín, Colombia.
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