Laying the foundation for what could be a pivotal clinical trial into Alzheimer’s (AD) detection, Optina Diagnostics and Wagner Macula & Retina Center will collaborate on a “real-world” study aimed at advancing Optina’s retinal deep phenotyping platform.
“It brings together a whole new paradigm for the way we think about, how we diagnose and how we understand brain health and Alzheimer’s,” said David Lapointe, Optina Diagnostics CEO, in a press release about the agreement.
“This is the first market readiness collaboration where Optina will deploy its exclusive eye clinic program and retinal deep phenotyping platform in a community setting. It will prepare the ground for additional prime eye clinics locations across the United States to develop a brain health expertise.”
A clinical trial (NCT03420807) into this platform, sponsored by Optina, is underway in Canada in people with probable Alzheimer’s, mild cognitive impairment, and healthy volunteers to test its ability to detect beta-amyloid plaques though retina imaging. This single site Ontario trial opened in December 2017 and is set to conclude in September 2020.
Wagner Macula & Retina Center, located in the Hampton Roads region of Virginia and North Carolina, will work with Optina in a real-world setting to capture eye images of individuals in its community who are at risk of AD. Results may support a future and pivotal clinical trial, the company said in the release.
“Most key opinion leaders agree that there is a need for earlier diagnosis when it comes to memory loss,” said Alan L. Wagner, MD, founder and president of the Wagner center. “Having the opportunity to participate in the final stages of Optina’s platform development, and collaborating with a well-characterized patient cohort coming from prominent memory clinics in Virginia and North Carolina, will allow Wagner Retina Macula Center to remain at the forefront of patient healthcare.”
The U.S. Food and Drug Administration granted Breakthrough Device Designation to Optina’s retinal imaging platform in May. The platform uses artificial intelligence to analyze the data-rich images captured with a metabolic hyperspectral retinal camera (MHRC) during an eye scan.
The hope is that, by detecting suspected beta-amyloid plaque in the retina, this noninvasive and relatively inexpensive tool could facilitate diagnoses of Alzheimer’s and other conditions marked by cognitive decline. Speedier detection could lead to earlier treatment and symptom management, and accelerate enrollment in clinical trials for disease-modifying therapies. Amyloid plaque, which disrupts nerve function, is a hallmark of AD.
The retina is a light-sensitive layer of tissue that lines the back of the eye. Because it’s attached to the brain, the eye can provide insight into neurological pathologies. When subjected to light in very specific colors, Optina’s experimental hyperspectral camera may be used to identify specific biomarkers based on unique spectral signatures.
Currently, no single diagnostic test can determine whether a person has Alzheimer’s. The diagnostic process involves assessing the patient’s medical history, clinical signs and symptoms, and laboratory tests. It also may involve brain imaging, including positron emission tomography, to rule out other conditions. But such imaging, upon which Optina’s technology is based, can be costly and is not widely accessible.
Without amyloid status evaluation, nearly one-third of patients in memory clinics who show signs of cognitive impairment are misdiagnosed, Optina, which is based in Montreal, said. In ambiguous cases, half these patients are incorrectly diagnosed.
The clinical trial in Toronto, Ontario, is said to be still recruiting and is testing Optina’s retinal deep phenotyping platform on up to 50 people. Subjects will undergo clinical characterization, ophthalmic evaluation, evaluation with the MHRC, and brain imaging. Participants, including healthy volunteers as well as those with mild cognitive impairment and probable AD, must be between 50 and 90 years old.