Optina's Landmark REPHRASE Study to Validate an Innovative Cerebral Amyloid Status Test for the Diagnosis and Management of Alzheimer's Disease

MONTREAL, July 17, 2023 /PRNewswire/ -- Optina Diagnostics' pioneering pivotal REPHRASE study, currently underway, is poised to revolutionize the diagnosis and management of Alzheimer's Disease (AD). This landmark study is focused on validating the novel awAIr™-Cerebral Amyloid Status (CAS) test, an innovative tool intended to provide physicians with definitive information about Alzheimer's pathology, enabling improved management of cognitive impairments.

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来源: PRNewswire

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.

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来源: PRNewswire

Alzheimer's disease is considered a growing crisis. Someone in the United States develops Alzheimer's disease every 60 seconds. By 2050 this is projected to be every 33 seconds and nearly 14 million Americans are estimated to be living with Alzheimer's dementia. To provide patients with a better chance of benefiting from treatment, it is key to diagnose the disease as early as possible. The team at Optina is working very hard to reducing time to accurate diagnosis.

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.

The REPHRASE study is being managed by Total Diversity Clinical Trials Management and is listed on www.clinicaltrials.gov under the ID NCT05107882.

About Optina Diagnostics

Optina Diagnostics is a pioneering medical imaging company focused on innovation and commercialization of AI-driven solutions for the early detection and monitoring of chronic diseases.

Optina's Retinal Deep Phenotyping™ (RDP™) solution allows for the detection of phenotypic biomarkers for pathologies that have manifestations in the retina.

With a mission to transform patient care by early detection and non-invasive diagnosis, the company's breakthrough technology has the potential to revolutionize the field of medicine by enabling healthcare professionals to intervene at the earliest stages of disease progression.

About the Diagnostics Accelerator

The Diagnostics Accelerator, created in July 2018, is a $100 million global research initiative from partners  including ADDF Co-Founder Leonard A. Lauder, Bill Gates, Jeff Bezos, MacKenzie Scott, the Dolby family, the Charles and Helen Schwab Foundation, The Association for Frontotemporal Degeneration, among others, to develop novel biomarkers for the early detection of Alzheimer's disease and related dementias.

This research initiative is dedicated to accelerating the development of affordable and accessible biomarkers to diagnose Alzheimer's disease and related dementias and advance the clinical development of more targeted treatments. Through translational research awards and access to consulting support from industry experts, this program will challenge, assist and fund the research community in both academia and industry to develop novel peripheral and digital biomarkers.

Contact details:

Luiz Augusto de Castro e Paula, PhD

Director of Innovation and Partnerships

Cell: +1 (438).828.1675

Email:

[email protected]

Website: www.optinadx.com

SOURCE Optina Diagnostics

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