The main is a public-private partnership, funded by the National Institute on Aging at the National Institutes of Health, Eli Lilly and Company, and several philanthropic organizations. USC鈥檚 Alzheimer鈥檚 Therapeutic Research Institute coordinates the trial, with about 70 study sites in several countries, including the United States, Canada, Australia and Japan.
The purpose of the A4 study is to test whether a new investigational treatment that may reduce beta-amyloid accumulation in the brain can also slow memory loss caused by Alzheimer鈥檚 disease. Amyloid is a protein normally produced in the brain that can build up in older people, forming amyloid plaque deposits.
Scientists believe this buildup of deposits may play a key role in the eventual development of Alzheimer鈥檚 disease-related memory loss. The overall goal of the A4 study is to test whether decreasing amyloid accumulation with an antibody investigational treatment can help slow the memory loss associated with Alzheimer鈥檚 disease.
鈥淥ur best chance of altering the disease may be to start treatment before people have symptoms,鈥� said Dr. Robert Rissman, substudy principal investigator and associate professor of neurosciences at UC San Diego. 鈥淓valuating new approaches such as retinal imaging will allow us to understand how Alzheimer鈥檚 neuropathology develops in the eye and how this parallels what is occurring in the brain itself. We are very fortunate to have the opportunity to conduct this substudy in A4 with our USC colleagues.鈥�
Using NeuroVision鈥檚 retinal imaging technology, the substudy will characterize retinal amyloid imaging findings in subjects with preclinical AD prior to administration of experimental treatment received as part of the primary A4 study protocol. The substudy will also assess longitudinal changes in retinal amyloid imaging in subjects with preclinical AD and whether it correlates with brain amyloid and cognitive change. One hundred subjects will be recruited into the substudy and imaged annually over three years.
鈥淚f successful, this technique could one day be used in the clinic to identify at-risk patients,鈥� said Dr. Michael Rafii, associate professor of neurology at USC and associate professor of neurosciences at UC San Diego. 鈥淒r. Rissman and I recently identified a strong neuropathological signal using NeuroVision鈥檚 retinal imaging system in adults with Down Syndrome, a group of individuals who are at increased risk for developing Alzheimer鈥檚 disease.鈥�
Steve Verdooner, CEO of NeuroVision, remarked that 鈥渢his is an exciting opportunity to evaluate our technology in a setting in which it could potentially add significant clinical value. Currently, evaluating amyloid plaque burden in the clinical setting is challenging and has limited scope for scaling up to meet the potential demand for effective new drugs. Our technology is designed to be easy-to-use, reliable and, being noninvasive, have minimal impact on patients. If it works in the way we expect, retinal imaging would streamline enrollment into clinical studies and could help identify candidates for new drugs and monitor their efficacy in a practical and accessible setting.鈥�
For more information about the A4 study, please visit .
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NeuroVision (www.neurovision.com) was formed in 2010 and is headquartered in Sacramento, California. Dr. Keith Black, the company鈥檚 chairman and co-founder, is an internationally recognized neurosurgeon, researcher and thought leader in areas of brain and blood-brain barrier function, enhancing the therapeutic effects of treatments in the brain, and optical imaging of the brain. He is the chair of Cedars-Sinai鈥檚 Department of Neurosurgery. Steven R. Verdooner, NVI鈥檚 CEO as well as a company director, is an experienced medical technology industry veteran who has successfully developed, commercialized and marketed ophthalmological imaging and measurement systems for other diagnostic applications.
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Media Contact: Sandy VanDirect Line: 808-526-1708Cell/Text: 808-206-4576Email: [email protected]
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