Propitious results from the new Alzheimer’s Drug.
A new hope to fight against Alzheimer’s disease, which is from a phase 2 clinical trial show that the medication, an antibody called BAN2401, slowed the progression of the disease and increased cognitive performance.
BAN2401 is produced by the Biogen and Eisai presented details about the clinical trial in July 25, 2018, at the Alzheimer’s Association International Conference in Chicago.
The trial involved 856 patients with mild cognitive impairment related to Alzheimer’s, who were divided into six groups. Five groups of patients were given various doses of the drug, and one group was given a placebo. The study assessed changes over 18 months by looking at levels of amyloid in the brain. Alzheimer’s patients have abnormal levels of the amyloid proteins that can clump together to form plaques. These plaques collect between neurons and disrupt cell function, according to the National Institute on Aging.
The study also used three common cognitive assessments for Alzheimer’s and dementia to determine changes in brain functioning.
At its highest dose, the drug reduced amyloid proteins as much as 93 percent. The trial also reported a 26 to 30 percent improvement in cognition.
Amyloids and Alzheimer’s
“This is the first late-stage anti-amyloid antibody study to successfully achieve statistically significant results at 18 months, further validating the amyloid hypothesis,” said Lynn Kramer, MD, chief clinical officer and chief medical officer of Eisai’s neurology business group.
“Overall, these findings are very exciting,” says Daniel Kaufer, MD, director of the memory disorders program at the University of North Carolina in Chapel Hill. “In this population, the treatment was able to reduce amyloids in people’s brains, and that that was correlated with clinical improvement in slowing people’s decline over 12 to 18 months.” he says.
Dr. Kaufer emphasizes that the clinically significant effects of the treatment correlated with the dose. “The higher the dose of treatment, the greater reduction in amyloid and the greater the clinical effect,” he says. “When you’re evaluating any treatment, that association is a very reassuring sign.”
Kaufer points out that one aspect of the trial’s design makes its findings a little more difficult to compare to a conventional study design. Rather than randomly distribute patients into six groups, the researchers used something called a Bayesian adaptive randomization design. “That means that as they enrolled new subjects in the study, they first looked at preliminary outcomes. They used that information to modify how they enrolled future subjects in the study,” says Kaufer. He adds that the approach makes it harder to speculate how these findings will translate into a real-world clinical practice.
But Kaufer is cautiously optimistic, and he expects that a phase 3 trial will provide answers to lingering questions. “Is it going to work? Is it going to be safe?” he asks. “Until those results, you really can’t say anything definitive about the treatment,” he adds.
The conclusion of that trial, as well as any potential approval by the Food and Drug Administration, are still two or more years away. “Part of the problem is that these studies take a long time,” Kaufer says. “The outcomes in this study were evaluated at 12 to 18 months. Even before that begins, it takes at least six months to enroll people in the study.”