The blinded clinical trial of 200 subjects is designed to correlate retinal plaque detected by NeuroVision’s noninvasive imaging test with brain plaque considered to be a hallmark sign of Alzheimer’s disease, using positron emission tomography, or PET, which is the current standard for clinical trials. Preliminary results of 40 patients showed that beta-amyloid levels detected in the retina with a simple eye test were significantly correlated with beta-amyloid levels in the brain that appeared using PET imaging. The retinal amyloid imaging test differentiated between Alzheimer’s and non-Alzheimer’s subjects with 100 percent sensitivity and 80.6 percent specificity. Beta-amyloid protein is the primary material found in brain plaques characteristic of Alzheimer’s disease. With the ability to detect plaques on the order of 20 microns, the test offers great promise for early detection.

Additionally, longitudinal studies on an initial cohort of patients demonstrated an average of 3.5 percent increase in retinal amyloid over a 3.5-month period of time. These initial findings have led to strong interest from several pharmaceutical companies and subsequent participation in therapeutic clinical trials in the hopes of further test validation, monitoring of progression over a short period of time, and assessment of therapeutic effectiveness.

"If longitudinal studies demonstrate that our test can detect changes in retinal plaque over a short period of time, we see great potential for using the technology not just for early detection, but also for measuring response to therapy," said NeuroVision CEO Steven Verdooner. "Tests currently used in clinical trials such as PET scan and measurement of amyloid and tau in CSF (via lumbar puncture) are invasive, expensive, and not conducive to repeated tests. We believe the ability to measure progression is very powerful and are engaging in partnerships for therapeutic trials to prove that out."

The clinical trial in Perth, Western Australia is a collaboration among Commonwealth Scientific and Industrial Research Organization (CSIRO), Edith Cowan University, McCusker Alzheimer’s Research Foundation and NeuroVision. It is also being conducted as part of the Australian Imaging, Biomarkers and Lifestyle Flagship Study of Ageing. The study is expected to be completed by the end of the year.

NeuroVision’s novel optical imaging system focuses on the retina, which unlike other structures of the eye is part of the central nervous system and shares many characteristics of the brain. Under the direction of Dr. Keith Black, professor and chair of Cedars-Sinai Medical Center’s Department of Neurosurgery, director of the Maxine Dunitz Neurosurgical Institute and the Ruth and Lawrence Harvey Chair in Neuroscience, researchers discovered several years ago that the plaques associated with Alzheimer’s disease occurred in the retina as well. NeuroVision, co-founded by Black and Verdooner, has expanded on Cedars-Sinai’s initial work by developing a proprietary test that utilizes a specialized camera with micron-level imaging resolution utilizing curcumin fluorescence imaging to detect retinal plaques. Curcumin fluorescence imaging is a process by which curcumin, a component of turmeric, binds to beta-amyloid in the retina. Curcumin has high affinity for beta-amyloid plaque as well as fluorescent properties. NeuroVision uses a proprietary high bioavailability curcumin formulation in the form of a supplement that patients take prior to imaging.

Researchers presented their findings in an oral presentation at the Alzheimer’s Association International Conference 2014 in Copenhagen, Denmark. Shaun Frost, a biomedical scientist and the study manager at CSIRO in Australia, was first author of the abstract. Researchers were also invited by conference organizers to present at a breaking news press conference.

"The unfortunate reality today is that Alzheimer’s disease is detected far too late for patients and their loved ones. While further study is needed, these preliminary results hold promise for the development of an easy exam that can detect disease sooner, paving the way for earlier interventions with new therapies," Frost said.