Imaging Sharpens Disease Research
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GE Healthcare, Chalfont St. Giles, UK, is currently developing diagnostic imaging agents for Alzheimer’s disease. Imaging agents that diagnose the presence of beta-amyloid plaque before disease symptoms manifest could potentially enable earlier treatment of the disease with better outcomes. They could also be used to facilitate development of Alzheimer’s drugs.“The whole idea is, if we can measure plaque, then not only can we identify Alzheimer’s patients, but we can also measure the effect of drugs, assuming that the drug effect is intended to reduce plaque,” explains Richard Frank, MD, PhD, vice president of medical and clinical strategy at GE Healthcare. Although drugs would need to demonstrate improvement of Alzheimer’s symptoms to be approved, the ability to see them affect plaque levels would improve decision-making and enable “labeling to include the additional claim of disease modification,” Frank says. Validated Alzheimer’s imaging agents could also be used to improve lead identification and optimization during preclinical development, Frank points out. In the last few years, PET scanners for small animals have become available, he says, which greatly facilitates translation of results from animals to humans.
Last year, the company announced that it will collaborate with Roche, Basel, Switzerland, in clinical trials of Roche’s anti-amyloid drug. Patients will be monitored with GE’s PET imaging agent, Pittsburgh Compound-B (PIB), Frank says. PIB was licensed by GE Healthcare from the University of Pittsburgh in 2003. The collaboration aims to validate the efficacy of both Roche’s anti-amyloid drug and GE’s diagnostic agent. In a separate collaboration, GE Healthcare is working with Eli Lilly, Indianapolis, to further expand GE’s portfolio of beta-amyloid diagnostic agents for Alzheimer’s disease. GE will have access to Lilly’s libraries, and Lilly will be able to utilize diagnostic agents that GE identifies through the partnership. By collaborating on the development of diagnostics and therapeutics for the disease at the same time, the companies hope to realize synergies on both fronts.Earlier this year, the National Institutes of Health launched the Alzheimer’s Disease Neuroimaging Initiative (ADNI), a $60 million, five-year study aiming to attract 800 participants through 58 trial sites located in the U.S. and Canada. “The primary goal is to try to develop and determine the best biomarkers of disease progression in Alzheimer’s disease,” says Susan Molchan, MD, program director for the ADNI project at the National Institute on Aging (NIA). The study will monitor patients using imaging technology, as well as blood, cerebrospinal fluid, and urine sample analysis.Molchan says that all participants in the study will receive serial anatomical MRI scans over a two- to three-year period. About half the participants will also receive FDG-PET scans to measure cerebral glucose metabolism. According to Molchan, prior studies have linked changes in MRI and FDG-PET scans with Alzheimer’s disease progression and risk factors.Initiated by the NIA, the ADNI study involves many federal agencies, pharmaceutical companies, and private non-profit organizations.