In new Alzheimer’s criteria, some see progress while others fear profit-driven ‘diagnostic creep’

With a second pricey drug to treat Alzheimer’s disease set to receive an approval decision soon, the nonprofit Alzheimer’s Association has published the final version of its new diagnostic criteria for the disease.

Editor’s note: “Dr. Sanjay Gupta Reports: The Last Alzheimer’s Patient” airs at 8 p.m. ET Sunday, July 7, on CNN. With another pricey Alzheimer’s disease treatment expected to receive an approval decision soon, the nonprofit Alzheimer’s Association has published the final version of its new diagnostic criteria for the disease. And for the first time, the criteria call on doctors diagnosing the disease to rely on biomarkers — pieces of beta amyloid and tau proteins picked up by lab tests or on brain scans — rather than pen-and-paper tests of memory and thinking. The idea behind the change, the authors say, is to catch the condition in its earliest and most treatable stages, even before symptoms develop. However, it also means people could be diagnosed with Alzheimer’s based on a blood test alone, even if they don’t have any memory difficulties. Biology should be the basis of the diagnosis, the authors argue, rather than symptoms. Furthermore, they say, just because a person doesn’t have symptoms doesn’t mean they won’t develop them down the line. But the criteria have been criticized by outside experts and drug industry watchdog groups who point out that people can have beta amyloid proteins in their brains and blood without ever developing dementia symptoms. They also point out that there’s no research to support the idea that giving a person expensive, risky injected medications before they show symptoms will benefit them in the long run. In clinical trials, the new drugs – which are antibodies that recognize and grab onto pieces of beta amyloid to remove them from the brain – showed modest benefits.