Optina's REPHRASE Study Validates Innovative Alzheimer's Test

The retina, located in the back of the eye, is actually part of the central nervous system and can be used as a proxy to the brain to detect changes caused by different diseases.

Optina Diagnostics will be discussing the REPHRASE study at the Alzheimer's Association International Conference, AAIC 2023, in Amsterdam, from July 16 to 20.

The existing diagnostic approach for Alzheimer's disease is ineffective and costly. Optina's awAIr™-CAS test represents a significant breakthrough in the field, recognized by the FDA through its Breakthrough Device designation program, providing a non-invasive, effective method to identify early signs of Alzheimer's disease. It consists of collecting detailed information from the retina during an eye scan. The collected data is then analyzed using advanced AI to pinpoint phenotypic changes in the retina that correlate with the presence of amyloid-beta plaques in the brain, a key factor in the Alzheimer's diagnosis.

Through the REPHRASE study, Optina aims to provide a groundbreaking approach to Alzheimer's diagnosis, enabling earlier disease diagnosis for better disease management, as well as facilitating accelerated development of new treatment modalities.

Involving adults over 50 who exhibit cognitive impairment symptoms that are consistent with potential AD, the study is being carried out at the following renowned clinical sites:

• Cleveland Clinic, Lou Ruvo Center for Brain Health (Nevada)
• East Virginia Medical School, Glennan Center for Geriatrics and Gerontology (Virginia)
• University of Washington, Memory and Brain Wellness Center (Washington)
• Ezy Medical Research (Florida)
• Sunnybrook Health Sciences Center (Ontario)
• Ottawa Memory Clinic (Ontario) / Clinique Mémoire d'Outaouais (Québec)
• Centricity Research (Ontario)

"Through its Rephrase study, Optina harnesses the unique potential of the eye, the only optical path into the human brain, to provide early-stage accessible diagnoses. By unraveling the profound impact of Alzheimer's disease on the retina, we are advancing towards improved early detection and treatment of this devastating disease," says David Lapointe, Optina's CEO. "Our efforts in this study pave the way for groundbreaking solutions that will benefit patients."

A participant in the REPHRASE Study expressed gratitude for the opportunity to contribute to research: "Taking part of this study has given me hope," says Maria, a 63-year-old study participant. "Knowing that I am contributing to the development of a tool that could diagnose Alzheimer's disease earlier, and possibly lead to better treatments in the future, is profoundly meaningful."

The study completion, anticipated by Q4 2023, represents an important milestone towards the FDA clearance and commercialization of the awAIr™-CAS test and is expected to profoundly impact the future of Alzheimer's diagnosis and treatment.

The REPHRASE study was funded in part by the Alzheimer's Drug Discovery Foundation's (ADDF) Diagnostics Accelerator under the project ID GDAPB-202103-2021548.