A total of 73 people with rare hereditary genetic mutations that cause the overproduction of the amyloid protein in the brain, which practically guarantees that they will develop Alzheimer’s disease at 30, 40 or 50 years, have participated in a clinical trial with … An experimental drug. The results, published in ‘The Lancet Neurology‘They show that the medicine Gantenerumab reduced the risk of dementia related to Alzheimer’s.
These findings are especially relevant because, for the first time in a clinical trial, they suggest that early treatment to eliminate amyloid plaques from the brain many years before the symptoms appear can delay the appearance of dementia by Alzheimer’s dementia.
Directed by the Essays of the Alzheimer’s Network of Dominant Inheritance of the Knight Family (Dian-Tu) of the Faculty of Medicine of the University of Washington in San Luis (USA), the study showed that, of the 73 participants of the study, in 22 who previously did not present cognitive problems at the beginning of the study and received the drug for a longer time (an average of eight years), the drug reduced the risk of developing symptoms of practically 100% to approximately 50%.
“All participants were destined to develop Alzheimer’s disease, and some have not yet developed it,” says the main author, Randall J. Bateman. Although it is still unknown for how long they will remain asymptomatic, perhaps years or even decades, Bateman points out that “to provide them with the best opportunity to maintain normal cognitive health, the treatment with another anti -amiloid antibody has continued with the hope that they will never develop symptoms. What yes We know that it is possible, at least, to delay the appearance of Alzheimer’s disease symptoms and provide more years of healthy life ».
The results also provide new evidence that supports the so -called amyloid hypothesis of Alzheimer’s disease, which postulates that the first step towards dementia is the accumulation of amyloid plaques in the brain, and that eliminating or blocking their formation can stop the appearance of symptoms.
The study of the study was originally registered in the Knight Family Dian-Tu-001 essay, the world’s first clinical trial for Alzheimer’s prevention, and who subsequently participated in an extension of the essay in which they received an anti-family drug.
The Knight Family Dian-Tu-001 trial, led by Bateman, was launched in 2012 to evaluate anti-ramyloid drugs as preventive therapies for Alzheimer’s disease. All participants had mild or zero cognitive impairment and were between 15 years before and 10 years after the scheduled age of the Alzheimer’s start, according to their family history.
When the essay concluded in 2020, Bateman and his colleagues reported that one of the drugs, the Gantenerumab, manufactured by Roche and Genentech, reduced amyloid levels in the brain and improved some measurements of Alzheimer’s proteins. However, no evidence of cognitive benefit was observed, since the asymptomatic group had not presented cognitive impairment regardless of the treatment received.
These disparate results led researchers to initiate an open extension to study the effects of the Gantenerumab with higher doses and a longer treatment. All Dian-Tu participants with high-risk genetic mutations for Alzheimer’s were eligible to continue in the extension, regardless of the previous treatment received.
All participants were destined to develop Alzheimer’s disease, and some have not yet developed it
Since in the extension everyone received the experimental drug, compared to people from the DIAN observational study who had not received treatment and with participants of the DIAN-TU treated with placebo that did not continue in the extension.
Originally scheduled for three years, this essay was interrupted in 2023 after the decision of Roche/Genentech to suspend the development of Gantenerumab, after phase 3 graduate and II tests did not fulfill their main objective of slowing down clinical deterioration.
The data analysis revealed that the elimination of amyloid plaques before the expected appearance of symptoms delayed its appearance and the progression of dementia, although the results were only statistically significant in the subgroup with the longest treatment.
To respond to how long the dementia can be delayed eliminating the amyloid protein, Dian-tu has launched a new essay. The majority of extension participants now receive Lecanemab, approved by the FDA in 2023 and pending approval in Europe although the European drug agency (EMA) has already initiated the approval process, whose data has not yet been analyzed.
Gantenerumab, explains Xavier Morató, Director of Clinical Trials of ACE Alzheimer Center Barcelona A Science Media Center, “It is a molecule with worse pharmacodynamic properties than other molecules (for example, Lecanemab, Donamemab, Tontinemab, Reternengu).”
Washu Medicine researchers have presented a NIH subsidy that, if approved, would provide funds to finish the essay. That subsidy is still pending review by NIH.
Both Alzheimer’s disease of early appearance and the late appearance begin with the slow accumulation of amyloid in the brain two decades before memory and reasoning problems arise. In addition, all the results of the essays of these families of Alzheimer’s mutations of early appearance have been replicated in rehearsals of Alzheimer’s disease of late appearance.
“If the latest initial Alzheimer’s prevention tests show similar results to those of Dian-Tu tests, there could soon be preventive measures for Alzheimer’s available for the general population,” says Bateman. I am very optimistic now, since this could be the first clinical evidence of what will become preventive measures for people at risk of Alzheimer’s. Soon, we could be delaying the appearance of Alzheimer’s for millions of people ».
Although Gantenerumab is no longer being developed, other anti -ramiloid medications are being evaluated such as preventive medications for Alzheimer’s disease.
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