An experimental Alzheimer's drug far outperformed placebo treatments in slowing the cognitive decline of Alzheimer's patients, Stat reported Wednesday, giving neurologists hope that an effective treatment for the disease is possible.
Patients who were given the drug, called BAN2401 and produced by Biogen and Eisai, "performed 30 percent better on a cognitive test than those getting placebo," Stat explained. The positive early returns may move the companies to approach the FDA for approval before conducting a larger study. But "there are caveats," Stat wrote: The drug's Phase 2 trial showed that the drug only outperformed placebo at its highest dose, and the highest dose was administered to just 161 patients. Moreover, the way Biogen and Eisai measured the drug's effectiveness is a proprietary method that has never been presented to the FDA before in an attempt to win approval.
Still, Stat called the results "unexpected and unprecedented." But it remains to be seen whether the companies will ultimately decide to operate a Phase 3 trial, or whether the FDA might be willing to lower the "traditionally high bar" it sets for approving Alzheimer's therapies, Stat wrote. "I'll remain cautiously optimistic," said Dr. Ronald Petersen, the director of the Mayo Clinic Alzheimer's Disease Research Center, but "you'd really want to see a Phase 3 to replicate those results." Read more at Stat. Kimberly Alters