Two RadNet sites will conduct PET/CT imaging for the Phase 1 trial of E2609, a BACE (beta-site amyloid precursor protein-cleaving enzyme) inhibitor, discovered and developed by Eisai Co., Ltd.
The study seeks to answer if E2609 can change the levels of beta-amyloid in patients with subjective memory complaints and mild cognitive impairment or mild dementia due to Alzheimer’s disease. If it can, it could conceivably be used to prevent the buildup of beta-amyloid in the brain that is a hallmark of Alzheimer’s disease and possibly the cause of Alzheimer’s-related degeneration of neurons.
The RadNet sites, one in Los Angeles and the other in Baltimore, will perform the PET/CT beta-amyloid imaging. The results will determine subject inclusion. This will help improve the quality of the results from the clinical trial.
Both sites have experience offering PET/CT imaging for Alzheimer’s disease using the FDA-approved Amyvid PET marker from Eli Lilly. However, the E2609 study will use GE Healthcare’s investigational PET amyloid imaging agent, [18F] Flutemetamol.
Judith Rose, MD, director of PET/CT and nuclear medicine for RadNet, tells ImagingBiz that RadNet radiologists will not be interpreting the test. This will be handled by a central reviewer that is part of the research team. However, the RadNet radiologists will be reviewing the images and thereby getting valuable experience with the new Flutemetanol tracer ahead of an anticipated approval by the U.S. Food & Drug Administration (FDA).
“We actually are learning how to interpret them as we are performing the exam as part of the research study,” Rose says. “It is a very big educational benefit ... There are not a lot of people in the general community who will have experience with it and we’ll have an advantage because we will have seen quite a few cases by the time it gets clearance.”
RadNet’s Shine a Light on Dementia program is the nation’s largest network of outpatient imaging centers that offers brain amyloid imaging with PET/CT as an Alzheimer’s test. Since performing the first such scan on July 30, 2012, RadNet has steadily increase its number of radiologists trained on the test and the number of sites that offer the test.
Because the FDA mandates that a PET/CT beta-amyloid brain imaging study performed with the Amyvid tracer can only be read as either positive or negative for Alzheimer’s disease, at RadNet, every such study is interpreted by two RadNet radiologists with Rose serving as the arbiter in case there is a disagreement between the two interpreting radiologists.
Partnering with Eisai and GE Healthcare to evaluate E2609 for the potential treatment of Alzheimer’s disease is “an opportunity to join industry leaders and explore the potential for new technology to help patients suffering from [Alzheimer’s disease],” stated RadNet President and CEO Howard Berger, MD, in the press release.