“We have developed clear procedures for classifying individuals who are asymptomatic or symptomatic in the preclinical stages of Alzheimer’s disease,” Kiselica said. “This is important because if a drug to treat Alzheimer’s is approved by the FDA down the road, the drug will likely be most effective on those with Alzheimer’s-related changes in the brain but no outward signs of cognitive decline yet.”
He noted that his research can help the developers of future medications meant to treat Alzheimer’s disease or dementia know what sort of people to include in their clinical trials since people who show signs of the condition could take a proposed Alzheimer’s drug that will possibly be ineffective. This is because the disease cannot be reversed once symptoms are present.
Kiselica’s study was published about a month before the Food and Drug Administration met to discuss approval of the first drug to treat Alzheimer’s disease in 20 years. However, Time magazine reported that during the seven-hour meeting, hopes of approval were stamped out as the FDA advisory committee expressed a list of concerns about the presentation of data tied to the drug, aducanumab, and the agency’s interpretation of that information.
“I don’t think the evidence from [the positive study] provides substantial evidence on the efficacy or the effectiveness of this drug,” committee member Dr. Aaron Kesselheim, associate professor of medicine at Harvard Medical School and Brigham and Women’s Hospital said.