Last week the New York Times reported that an advisory committee for the F.D.A. recommended unanimously that the agency approve the first-ever test that allows physicians to see the plaques typically associated with Alzheimer’s disease in a living person. The brain-scan in itself is not a breakthrough, but approval from the F.D.A. would allow the use of a dye that targets the plaque buildup in the brain and makes it visible through a PET scan. The success of this dye however, would be a groundbreaking achievement for Alzheimer’s researchers because until now the only way to conclusively indentify a person with Alzheimer’s disease was through post-mortem analysis.
“[The panel’s vote] has moved us a monumental step forward… [With the scans] we will not just be guessing clinically,” said Dr. Reisa Sperling, Director of the Center for Alzheimer’s Research and Treatment at Brigham and Women’s Hospital in Boston.
At the F.D.A. meeting last Thursday in White Oaks, Md. medical experts testified about the need for such scans. Such scans would be valuable to geriatric physicians who many times are tasked with having to decide whether a person is actually suffering from Alzheimer’s disease or whether the cognitive deterioration is due to other conditions. Dr. Norman Foster, professor of neurology at University of Utah and consultant to GE Healthcare, spoke at the meeting and gave anecdotes of patients he had seen in the past weeks who would have benefited from a scan like the one propose. One such patient had been diagnosed with depression and it took two years of progression and cognitive decline before it became clear that the cause was most likely Alzheimer’s disease.
“Physicians currently have little confidence in their ability to determine the cause of dementia, and as a result they often don’t even try… As a result families are left in limbo, unable to plan for the future if it is Alzheimer’s and, if it is not, delaying getting treatment,” explained Dr. Foster.
The scan-tests are now just pending approval from the F.D.A., but the agency typically follows the advice of its advisory committee as long as other contingencies have been addressed. The approval of the scan-test is only contingent on agreement among radiologist of what the scans say and also on doctors being trained on how to read the tests, a hurdle that should slow the process a matter of months, rather than years according to Dr. Daniel M. Skovronsky, CEO of the pharmaceutical company that manufactures the dye.
As the explosion in neurological research sheds more light on cognitive diseases, many other major healthcare industry players have begun development of tools to assist physicians in treating Alzheimer’s and other forms of dementia more effectively. GE Healthcare is developing their own brain scan for plaque and Silverado Senior Living is working with Dr. Natalie Rasgon of Stanford University on an ongoing study of a new brain imaging compound.
