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The AHEAD Study is the first ever clinical trial to test the effect of lecanemab (investigational antibody) in people who have no cognitive symptoms of Alzheimer’s disease (AD), but in whom biomarker tests indicate amyloid is present in the brain, known as “preclinical” AD. The AHEAD Study is also the first AD trial to recruit people as young as 55 years old who are at risk of developing symptoms of AD as they get older. The AHEAD Study will test whether the clinical effects reported in the Clarity AD clinically symptomatic population are similar in the AHEAD preclinical AD population.
Eisai recently announced positive topline results from Clarity AD, a phase 3 study evaluating the safety and effectiveness of lecanemab, an investigational anti-amyloid beta (Aβ) protofibril antibody for the treatment of mild cognitive impairment (MCI) due to AD and mild AD dementia (collectively known as early AD) with confirmed presence of amyloid pathology in the brain.
“The AHEAD Study is testing lecanemab in a much earlier stage of AD than the Clarity AD trial,” said Dr. Reisa Sperling, professor of neurology at Harvard Medical School, and co-principal investigator of the AHEAD Study. “The ability to identify people at risk for developing cognitive decline due to AD based on amyloid PET provides the opportunity to test whether early intervention can delay cognitive decline.”
The AHEAD study incorporates innovative features such as screening with plasma biomarkers, novel PET imaging agents, sensitive cognitive outcome scales, dosing tailored to the level of amyloid in the brain, and recruitment approaches to ensure diverse representation. Plasma prescreening and analysis of baseline imaging will be presented at CTAD in November.
The AHEAD Study is funded by the National Institutes of Health (NIH) and Eisai Inc., a U.S. subsidiary of Eisai Co., Ltd. (Headquarters: Tokyo), and seeks 1,165 participants from North America. The study has more than 100 study locations worldwide, including North America, Japan, Singapore, Australia and Europe.
To learn more about the AHEAD Study, call 1-800-AHEAD-70 or to find a trial site location enrolling near you, visit 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 NIH.
This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such an investigational agent will successfully complete clinical development or gain health authority approval.
About AHEAD / Lecanemab
The AHEAD Study is made up of two different clinical trials testing the same investigational drug (known as BAN2401) at different doses. During the study, participants will receive intravenous (IV) infusions of BAN2401 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 Lecanemab
Lecanemab (BAN2401) 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). 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, 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 for the treatment of AD pursuant to an agreement concluded with BioArctic in December 2007. Results from the global clinical Phase III study (Clarity AD) of BAN2401 in early AD were recently announced. Now also in a Phase III trial (AHEAD 3-45) for preclinical AD. BAN2401 is being jointly developed by Eisai and Biogen Inc. (Headquarters: Cambridge, M.A.).
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).
