The ADDF's Diagnostics Accelerator Authors New Paper on Ocular Biomarker Landscape, Highlighting Ocular Tests as a Tool for Early Detection of Alzheimer's Disease

New findings published in Alzheimer's & Dementia suggest blood biomarkers are expected to become the standard method for diagnosing Alzheimer's, while ocular tests offer a non-invasive alternative for detecting at-risk patient populations

NEW YORK, March 12, 2025 /PRNewswire/ -- The Alzheimer's Drug Discovery Foundation's (ADDF) Diagnostics Accelerator (DxA) authored a first-of-its-kind paper, "Unlocking ocular biomarkers for early detection of Alzheimer's disease," providing a landscape review of ocular biomarkers as another tool, alongside blood biomarkers, to aid in the early detection of Alzheimer's disease. The paper, which was published in Alzheimer's & Dementia, shares an informed perspective on the role of ocular biomarkers in the broader Alzheimer's diagnostics space and what defines a true ocular biomarker, while also highlighting the potential for ocular screening to identify at-risk patients who would otherwise go undiagnosed. The authors' assessment is based on hours of in-depth interviews with leading neurologists, ophthalmologists, optometrists, and primary care physicians from across the United States.

"Meaningful progress is being made in Alzheimer's research, with advances in novel biomarkers – including blood tests, retinal scans and digital tools – providing less invasive and more accessible ways to detect and diagnose Alzheimer's disease," said Howard Fillit, MD, Co-Founder and Chief Science Officer of the ADDF. "With the advent of these new tools, it is important to understand the appropriate context of use for each test. This paper shares a new and more nuanced perspective on the role of ocular biomarkers, which have the potential to identify at-risk individuals during routine eye exams, who otherwise may go undiagnosed."

Blood-based testing for Alzheimer's is more cost-effective, convenient, and less invasive than current diagnostic methods and blood biomarkers are most likely to emerge as the standard clinical practice for Alzheimer's diagnostics. For patients to receive an Alzheimer's blood test, they must see their primary care doctor or a neurologist, which is not always accessible to all patients. As stated in the paper, the authors categorize ocular biomarkers as an additional non-invasive and accessible option to identify people at risk for Alzheimer's disease (e.g., pre-symptomatic) outside of the traditional settings of an annual physical or an exam with a neurologist.

Ocular technologies are expected to cost between $100-200 of out-of-pocket costs and must meet minimum performance standards of 90-95% sensitivity and 75-85% specificity to qualify as a test for preclinical Alzheimer's. The authors believe focusing on these factors will help identify which of the four to eight million aging Americans who undergo an annual eye exam and who may be at risk for developing Alzheimer's.

"This paper highlights the critical requirements and path to success of retinal biomarkers in Alzheimer's disease (AD) diagnosis", says Niranjan Bose, Managing Director, Health and Life Sciences at Gates Ventures. "While blood-based biomarkers are poised to take the lead in AD diagnostic applications, retinal biomarker testing can play a vital role in detecting preclinical AD and supporting differential diagnosis in neurodegenerative conditions. However, to make a meaningful impact in the future, it must meet rigorous technical standards similar to blood-based tests and demonstrate clinical utility to ensure integration as a reliable tool in early AD detection."

Research into ocular biomarkers for detecting Alzheimer's disease is ongoing with early findings pointing to biomarkers in the retina as having the potential to provide key indicators of the disease. The retina displays similarities to the brain's cellular composition, and several neurodegenerative disorders are known to have manifestations in the retina. With ongoing technological advancements, ocular biomarkers have the potential to become a scalable, accessible tool that can be integrated into routine eye exams, making early detection of Alzheimer's disease more feasible and improving outcomes for at-risk individuals.    

"The pace of innovation in the Alzheimer's field has accelerated greatly in recent years, but major gaps persist, particularly in early, pre-symptomatic patient identification.  Ocular biomarkers offer a novel method to detect the earliest molecular beginnings of Alzheimer's disease, and to do so with the potential for elevated sensitivity and without the burden of more invasive tests," said Sam Ulin, a Partner at ClearView Healthcare Partners who specializes in the translation of innovative technologies into clinical application.  "Our work here with the DxA can hopefully serve as a guidepost to innovators in the space, helping them understand what is needed for an ocular biomarker test to meet the needs of patients and practitioners, maximizing the impact of these technologies on AD research, development, and ultimately, patient care."

About The Alzheimer's Drug Discovery Foundation (ADDF)
Founded in 1998 by Leonard A. and Ronald S. Lauder, the Alzheimer's Drug Discovery Foundation is dedicated to rapidly accelerating the discovery of drugs to prevent, treat and cure Alzheimer's disease. The ADDF is the only public charity solely focused on funding the development of drugs for Alzheimer's, employing a venture philanthropy model to support research in academia and the biotech industry. The ADDF's leadership and contributions to the field have played a pivotal role in bringing the first Alzheimer's PET scan (Amyvid®) and blood test (PrecivityAD®) to market, as well as fueling the current robust and diverse drug pipeline. Through the generosity of its donors, the ADDF has awarded more than $370 million to fund 765 Alzheimer's drug discovery programs, biomarker programs and clinical trials in 21 countries. To learn more, please visit: http://www.alzdiscovery.org/.

ABOUT THE DIAGNOSTICS ACCELERATOR (DxA) 
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. 

ABOUT CLEARVIEW HEALTHCARE PARTNERS
ClearView is the leading independent strategy consulting firm focused on the life sciences. The Company was founded on the core belief that companies driving innovation in the life sciences need strategic partners that can combine deep scientific expertise, robust analytic approaches, and sound business instincts to create actionable and impactful results. These principles have enabled ClearView to build enduring partnerships with clients across the industry and around the globe, where we thrive in engagements where the stakes are high and the answer uncertain. ClearView meets these challenges with transparent problem-solving and dedicated thought partnership to create clarity on the path forward. For further information please visit www.clearviewhcp.com.

SOURCE Alzheimer's Drug Discovery Foundation