New Blood Test To Identify People At Risk Of Developing Alzheimer's Symptoms Will Be Used In Clinical Trial Aiming To Prevent Memory Loss

• Research presented today highlights advantage of using blood test for trial that aims to prevent Alzheimer's
• Up to 75 research centers across North America will use blood tests to identify those most at-risk for changes in the brain from Alzheimer's disease, thus, expediting prevention research​

Boston, MA /PRNewswire/ - Research presented today at the international Clinical Trials on Alzheimer's Disease (CTAD) conference in Boston indicates a blood test can be used to identify people with an increased likelihood of having brain amyloid, a protein that's a risk factor for developing Alzheimer's symptoms.

The research shows a new blood test called PrecivityAD™, developed by C₂N Diagnostics, is 81% accurate (with an area under the receiver operating characteristic curve [AUROC] of 0.87) in predicting the level of amyloid on a PET scan, the traditional method to determine build-up of amyloid plaques in the brain, among people who do not show symptoms of Alzheimer's disease. For the first time, the blood test will be used in a clinical trial aiming to prevent the symptoms of Alzheimer's disease—called the AHEAD Study —that is enrolling people as young as 55.

"Blood-based screening is a giant leap forward in detecting changes in the brain among people who do not yet show memory loss symptoms," said Reisa Sperling, MD, director of the Center for Alzheimer Research and Treatment at Brigham and Women's Hospital, Harvard Medical School and co-principal investigator for the AHEAD Study. "New blood test technology can help identify those more likely to have Alzheimer's disease changes in their brains, which enables them to enroll in prevention or treatment trials as early as possible. This is a remarkable achievement that may lead to detecting and treating Alzheimer's much earlier, and hopefully one day, preventing the memory loss associated with this devastating disease."

Results presented at CTAD show the blood test identifies specific amyloid proteins in blood plasma and is a promising way to test someone's likelihood of having amyloid build-up in the brain. Screening blood tests should greatly speed up clinical trial enrollment, a long and expensive process, according to researchers.

Another major goal for the AHEAD Study is to recruit a diverse population of participants. "We also hope that this new test will make it easier for people from diverse backgrounds, especially people of color, to learn if they might be right for the study by starting with this simple blood test," said Dr. Sperling.

Funded by the National Institutes of Health (NIH) and Eisai Inc., a U.S. subsidiary of Eisai Co., Ltd., the AHEAD Study is enrolling people between the ages of 55 and 80 to test whether removing amyloid plaques in the brain can delay or prevent the onset of Alzheimer's symptoms. The study will enroll 1,165 participants from North America, with research centers in 75 U.S. and Canadian communities. Researchers believe their use of a screening blood test will lower barriers to participating in clinical trials, especially among communities of color, which are historically underrepresented in Alzheimer's trials.

Study locations and eligibility requirements can be found at AHEADstudy.org.

Research reported in this press release was supported by the NIH's National Institute on Aging under award numbers R01AG054029 and R01AG061848. The AHEAD Study (Clinical Trial number NCT04468659) received funding from NIH and from nongovernmental sources. The content is solely the responsibility of the researchers and does not necessarily represent the official views of the National Institutes of Health.

About AHEAD / BAN2401 (lecanemab)
The AHEAD Study is made up of two different clinical trials testing the same investigational treatment (known as BAN2401, lecanemab) at different doses. During the study, participants will receive intravenous (IV) infusions of BAN2401 (lecanemab) tailored to their risk of developing memory loss, or a placebo, an inactive substance designed to mimic the appearance of the drug. At different points in the study, participants have a PET scan (or Positron Emission Tomography brain scan) to look at amyloid and tau (another protein) in the brain. The PET scan takes pictures of participants' brains, allowing researchers to see and track changes in amyloid and tau levels.

About BAN2401 (lecanemab)
BAN2401 (lecanemab) is a humanized monoclonal antibody for Alzheimer's disease (AD) that is the result of a strategic research alliance between Eisai and BioArctic AB (Headquarters: Sweden). BAN2401 (lecanemab) selectively binds to neutralize and eliminate soluble, toxic Aβ aggregates (protofibril) that are thought to contribute to the neurodegenerative process in AD. As such, BAN2401 (lecanemab) may have the potential to have an effect on disease pathology and to slow down the progression of the disease. Eisai obtained the global rights to study, develop, manufacture and market BAN2401 (lecanemab) for the treatment of AD pursuant to an agreement concluded with BioArctic in December 2007. Currently, a global clinical Phase III study (Clarity AD) of BAN2401 (lecanemab) in early AD is underway as well as a Phase III trial (AHEAD 3-45) for preclinical AD. In September 2021, Eisai initiated a rolling submission of a Biologics License Application (BLA) for lecanemab for the treatment of early AD, to the U.S. Food and Drug Administration (FDA) under the accelerated approval pathway. BAN2401 (lecanemab) is being jointly developed by Eisai (Headquarters: Tokyo, Jpn) and Biogen Inc. (Headquarters: Cambridge, M.A., USA).

About C₂N Diagnostics
C2N is a specialty diagnostics company with a vision to bring Clarity Through Innovation™. The Company strives to provide exceptional laboratory services and products in the field of brain health. C2N's biomarker services and products are used for: clinical decision making to support patient care, including diagnosis and treatment monitoring; improving the quality and efficiency of clinical trials that test novel treatments for neurodegeneration; and providing innovative tools to help healthcare researchers better understand novel mechanisms of disease, identify new treatment targets, and conduct important epidemiologic studies to improve global public health. For more information visit: www.C2N.com.

About the Alzheimer's Clinical Trials Consortium
The Alzheimer's Clinical Trial Consortium (ACTC) is a state-of-the-art infrastructure network established with funding by the NIA to support the conduct of clinical trials across the continuum of Alzheimer's Disease (AD). The ACTC leverages the depth and breadth of AD clinical research teams at USC, Harvard, and the Mayo Clinic, as well as the considerable experience of investigators at 35 expert AD trial sites to provide an optimal infrastructure, utilizing centralized resources and shared expertise, to accelerate the development of effective interventions for Alzheimer's disease and related disorders (ADRD).