North Bethesda, MD, October 4, 2022—The Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium (BC) has launched a project that signals a paradigm shift in our methods to image the brain. Using advances in PET (positron emission topography) technology, the project will focus on measuring the integrity of synapses—tiny gaps that connect neurons and communicate information to the brain. Loss of these synapse connections strongly correlates with cognitive decline in Alzheimer’s disease (AD). A new imaging tool to track this biological indicator of disease progression and of patient response to therapeutic interventions would be a catalyst in the development of clinically effective treatments for AD.

An estimated 6.5 million people live with AD in the United States, and it is projected that by 2050 this could increase to almost 13 million.¹  Alzheimer’s disease is most known for signs and symptoms that include loss of memories, decreased ability to communicate, and reduced ability to perform daily activities independently. People can live for several decades with the disease, making AD care an emotional and costly burden not only to patients but also to their families, caregivers, and society.

PET scans use a radioactive tracer to image normal and abnormal activity in many different organs. This technique is currently used to track the buildup of amyloid and tau proteins, two markers that serve as early indicators of Alzheimer’s disease but are not directly related to the biological underpinnings of cognitive loss. Recently, a PET tracer has been developed to bind to the synaptic vesicle glycoprotein 2A (SV2A), a protein located in neural synapses widely distributed throughout the brain. SV2A provides an opportunity to view the density of synapses and their decline. Studies using this PET tracer have demonstrated reduced SV2A binding in specific regions of the brain in Alzheimer’s patients, yet the biological basis of the alterations in SV2A is not well understood. The FNIH study seeks to thoroughly validate the SV2A PET tracer as a biomarker that can be used to measure therapeutic interventions in clinical trials and accelerate development of better treatments.

This three-year, $5.5M project brings together key stakeholders to advance our knowledge of the biological underpinnings of SV2A and the interpretation of the SV2A PET signal. Project partners include three institutes from the National Institutes of Health, 10 industry and nonprofit partners, individual donors, and four academic partners and service providers. This project will be an important first step toward a more expanded use of this important new biomarker to diagnose and treat other challenging neurodegenerative and neuropsychiatric diseases that affect the function and density of synapses, such as frontotemporal degeneration, schizophrenia spectrum disorder, major depressive disorder, and autism spectrum disorder. Building on more than two decades of commitment to finding solutions for AD, the FNIH is privileged to bring together these talented and diverse stakeholders dedicated to precision medicine and brain health.

For more information about the project, click here. To read what our partners are saying about the project, click here.

About the Biomarkers Consortium:
The Foundation for the National Institutes of Health’s Biomarkers Consortium (BC) convenes government, industry, patient advocacy groups, and not-for-profit organizations to address one of the most pressing needs in the diagnosis and treatment of disease: the development and the seeking of regulatory approval for disease biomarkers and surrogates. The core operations of the Biomarkers Consortium are supported through the contributing membership program. Organizations representing private industry (including the pharmaceutical, biotechnology, diagnostics, and information technology industries) and not-for-profit organizations (including associations, advocacy groups, trade organizations, and philanthropic organizations) that wish to support biomarkers development are eligible to become contributing members.

About the Foundation for the National Institutes of Health:
The Foundation for the National Institutes of Health (FNIH) creates and manages alliances with public and private Institutions in support of the mission of the NIH, the world’s premier medical research agency. The FNIH works with its partners to accelerate biomedical research and strategies against diseases and health concerns in the United States and across the globe. The FNIH organizes and administers research projects; supports education and training of new researchers; organizes educational events and symposia; and administers a series of funds supporting a wide range of health issues—all efforts focused on areas of unmet need, paving the way toward better patient experiences and outcomes. Established by Congress in 1990, the FNIH is a not-for-profit 501(c)(3) charitable organization.