On Thursday, January 20, 2011, an Advisory Committee to the U.S. Food and Drug Administration (FDA) unanimously recommended FDA approval of a new brain dye product that would for the first time enable a brain scan to show whether plaques indicating Alzheimer’s Disease are present in the brain. This would be the first test able definitively to diagnose Alzheimer’s Disease during a person’s lifetime. Until now, the only definitive way to diagnose the presence of Alzheimer’s has been through a brain autopsy after death.
The recommended approval of the new dye was contingent on the FDA applicant’s establishing a medically agreed “bright line” diagnostic criteria as to the level of plaque that would need to be present in the brain in order to justify a definitive diagnosis of Alzheimer’s.
The Alzheimer’s Association reports that 5.3 million Americans have Alzheimer’s Disease, and statistics have indicated that nearly 50% of people over age 85 have Alzheimer’s Disease. “A definite diagnosis of Alzheimer’s disease depends on finding plaques and tangles in the brain..,” according to the Cleveland Clinic’s Overview of the disease. Up until now, this definitive diagnosis has only been possible through an autopsy after death.
The specific product now up for approval by the FDA is a type of dye that would attach to plaque in the brain, making it visible in Positron Emission Tomography (PET) Scans. The dye is being developed by Avid Radiopharmaceuticals, a subsidiary of Eli Lilly & Company.
Many medical professionals testified before the FDA Advisory Committee urging approval of the new diagnostic test, including a scientist on the payroll of a competing company, according to a report in the New York Times. Many opined that this new test would be a significant breakthrough. For the first time, it would allow doctors, presented with a patient exhibiting symptoms of memory loss, to make a definitive diagnosis. If the test finds that plaques are not present in the brain, doctors and families can feel confident ruling out Alzheimer’s. Doctors can then focus on treating other potential causes of the symptoms without delay, which can help save lives. If Alzheimer’s is diagnosed, patients and families will gain needed time to plan for the future.
According to Dr. Norman Foster, a professor of neurology at the University of Utah, as quoted in the New York Times article, approval of the scan test “would be a historic advance in neurology and in the daily management of patients with memory complaints.”
Read the original Briefing Document presented to the FDA Advisory Committee for its January 20, 2011 meeting, explaining in detail the proposed new brain dye product and how it would work to enable a PET Scan test that could diagnose the presence of Alzheimer’s Disease. This document was prepared by Avid Radiopharmaceuticals, the applicant for FDA approval of the dye.
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