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The AHEAD Study Is Testing Lecanemab At The Stage Of Preclinical Alzheimer's Disease

SAN DIEGO, July 11, 2023. Alzheimer's disease (AD) researchers increasingly believe that treating at the earliest possible stage may be key to helping combat the disease. Ongoing studies are now testing whether lecanemab can effectively delay or prevent the symptoms of disease if started even before there is evidence of cognitive impairment.

The AHEAD Study (AHEADstudy.org) is testing the effect of lecanemab in people who have no cognitive symptoms of AD but in whom biomarker tests indicate amyloid is present in the brain, known as the "preclinical" stage of AD. The AHEAD Study is 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.

On July 6, the Food and Drug Administration granted full approval to LEQEMBI (lecanemab) for the treatment of AD. Under the current FDA approval, treatment with lecanemab should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. Lecanemab is the first approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline in adults with AD (Eisai Press Release).

Lecanemab is now fully approved to treat people who already have cognitive impairment and mild dementia (substantial memory and other thinking problems that affect daily function) due to AD. Lecanemab had previously been granted accelerated approval for demonstrating that the treatment reduced the accumulation of brain amyloid plaque (a hallmark change in the brain of a person with AD). The AHEAD Study builds on the positive results that lecanemab showed in people with mild cognitive impairment or mild dementia in the Clarity AD Study. Studies like the AHEAD Study are necessary to test if lecanemab can help stave off the memory problems caused by AD, if started before cognitive impairment is clinically evident.

"The advances in treating people who already have cognitive problems due to Alzheimer's disease are incredibly exciting, but to have the greatest impact on the public health crisis of Alzheimer's disease, we may need treatments to start even earlier," said Reisa Sperling, M.D., professor of Neurology at Harvard Medical School and co-principal investigator of the AHEAD Study. "The AHEAD Study is the first study to test whether removing amyloid plaques from the brain before symptoms are evident could be effective at preventing memory problems from the beginning."

The AHEAD Study incorporates innovative features such as screening with biomarkers in blood, 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.

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.

About AHEAD / Lecanemab
The AHEAD Study is made up of two different clinical trials testing lecanemab at different doses. During the study, participants will receive intravenous (IV) infusions of 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 Lecanemab
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). 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 lecanemab 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 lecanemab in early AD were recently announced. Now also in a Phase III trial (AHEAD 3-45) for preclinical AD, Lecanemab is being jointly developed by Eisai and Biogen Inc.

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).

INDICATION
LEQEMBI is indicated for the treatment of Alzheimer's disease. Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.

SOURCE Alzheimer's Clinical Trials Consortium

Posted: July 2023

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