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(CNN) – After a series of important failures, it is hoped to find a drug that can slow the progression of the disease. ; Alzheimer's. The results of an early trial of an experimental drug showed that it improved cognition and reduced the clinical signs of Alzheimer's in the brain of study participants, and the experts are "cautiously optimistic" that the results will be replicated in future clinical trials
an antibody called BAN2401, not only reduces the formation of new beta-amyloid clusters in the brain, but reduces existing clusters by an average of 70% announced on Wednesday the biotech company Biogen and the Japanese drug manufacturer Eisai. The accumulation of beta-amyloid in the brain is a hallmark of Alzheimer's disease.
BAN2401 also provided a 26% to 30% advantage over a placebo in improving cognition in study subjects, according to the researchers. Details on immunotherapy were presented at a press conference at the International Conference of Alzheimer's in Chicago in 2018.
"These are people with mild alterations, forgetting the name of someone on the occasion. Lynn Kramer, Head of Clinical and Medical Services of Eisai. "It's the goal: to stop Alzheimer's disease when it's in the sweetest presentation."
The reaction of the experts was mixed. "I would not say shock and admiration," said Dr. Julie Schneider, professor of pathology at Rush Medical College. "It is encouraging to see a cognitive effect and a slowing of the progression of the disease, but I personally think that there is still much to do."
Maria Carrillo, scientific leader of the nonprofit Alzheimer's Association "is the future, and there will be no bullet to defeat the Alzheimer's disease, so be able to delay the progression of the disease for a few years would be huge. "
Dr. Richard Isaacson, who heads the Alzheimer's Disease Prevention Clinic at the New York-Presbyterian Medical Center / Weill Cornell, said the research is "awesome on the surface, but we need to be cautiously optimistic." These data may to be encouraging, but it is impossible to say Of course, I do not want us to be wrong, "as in past trials that failed.
BAN2401 is administered intravenously and has been tested in five doses in 856 patients with mild or early-stage cognitive impairment. Alzheimer's in a phase two trial, which evaluates the dosage of a drug.
Hoping that the drug would be a viable treatment had decreased in December when participants showed significant improvement by the first goal of the 12-month study. However, Biogen recently stated that the highest dose of 10 milligrams per kilogram of a patient 's body weight, administered every two weeks, showed a statistically significant success at the completion of the treatment. 18 months study.
Kramer says that Eisai and Biogen have contacted regulators in the United States. States, Europe and Japan to discuss results and next steps. The company said it hoped to obtain accelerated approval.
"This was only a phase two trial, and it will not be approved by the Food and Drug Administration until the results of the next test will be known," explained Keith Fargo. , director of scientific programs at the Alzheimer's Association. "Accelerated approval simply means that you go to the front instead of the back of the line."
For patients eagerly waiting for help, Fargo warned that it will take several years before the drug is available.
"You will not be able to see a doctor and get this anytime soon," said Fargo
Safety and Side Effects
showed that BAN2401 was well tolerated at all levels, including much lower rates of a well-known side effect of anti-amyloid therapy: microblocking and minor swelling in the brain called amyloid-related imaging abnormalities, or ARIA-E
said that less than 10% of patients in any of the five treatment arms experienced ARIA, which can create headaches, confusion and visual disturbances that resolve once the drug stopped .
ARIA-E, only five were symptomatic, "said Kramer," and could not be identified with an MRI. Of these, only one couple had external symptoms.
Patients with an ApoE gene ε4, the leading genetic risk factor for Alzheimer's disease, are more susceptible to ARIA-E problems. a regulatory body outside the United States asked researchers to remove most of the patients from the high-dose benefit group who received injections twice a month, but left patients with ApoE ε4 in their placebo arm. # 39; study.
According to Isaacson, this may have created a major loophole in research.
"ApoE ε4 patients decrease more rapidly," he said. "The study seemed so good because she was putting all ApoE's at the 4-arm placebo, or was the study good because the lowering of the study was good. Amlyoid improves cognitive function? It's the confusing part. "
Isaacson says clinical doctors who see patients with ARIA-E who are also ApoE ε4-positive recommend that they stay in a high-dose group, because the side effects are often manageable.
"Regulators have to enter the same room as the researchers and agree on things so that these confusing changes do not happen halfway through," he said.
BAN2401 is one of many potential drugs using the "amyloid hypothesis," a belief that amyloid beta suppression is expected to improve memory loss and other cognitive changes seen in Alzheimer's disease, training, cause the immune system to kill it or remove it from the bloodstream and brain.
By the end of 2016, Eli Lilly's solanezumab n & # 39 did not surpbad the benefits of placebo in one trial phase III of 2100 patients. In 2013, P fizer discarded another antibody, bapineuzumab, when it did not surpbad the placebo effects in another phase three trial. Experts suggest that advanced stages of Alzheimer's disease among participants in both trials might have contributed to the failures.
Pharmaceutical giant Merck has used a different approach to combat beta-amyloid in people with advanced Alzheimer's disease. In early 2017, after an independent study, he concluded that he had "virtually no chance" of working. A second attempt to treat the early stages of Alzehimer was also discontinued in February.
The atabecestat, a Johnson & Johnson BACE inhibitor designed to slow cognitive decline in people at risk for Alzheimer's, was also discontinued in May. One possible reason for the success of BAN2401, said Kramer, is that the trial was among the first to use PET scanners to verify that every participant in the study had definite signs of beta amyloid in their brain. Older studies have finally shown that a number of patients tested did not actually have the aggregates and plaques targeted, which could explain failure rates.
The other Biogen amyloid antibody, aducanumab, also uses the PET scan model in his tests. . Aducanumab binds to a different type of amyloid protein in the brain than BAN2401.
Biogen announced the updated results of a 24 month trial on aducanumab Sunday at the conference. The latest data has shown a "beneficial effect" in cognition for patients with pre-Alzheimer's disease. He also showed a decrease in beta-amyloid plaque levels in a subgroup of ApoE ε4 gene transporters, the leading genetic risk factor for Alzheimer's disease. However, the full results of the study are not expected for a year or two.
The results of these two studies are intriguing, said the Alzheimer's Association
"This is the second trial to show amyloid reduction and some improvement in cognition," said Carrillo. "The amyloid hypothesis remains an important therapeutic target to pursue in Alzheimer's disease."
The last drug against Alzheimer's disease approved by the Food and Drug Administration was in December 2014, and it was a combination of two existing drugs.Before that, a new drug for Alzheimer's disease had not entered the market since 2003. Of the five drugs approved by the FDA to treat Alzheimer's disease, none slow down its progression.
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