Alzheimer’s clinical trials testing Novo Nordisk’s blockbuster GLP-1 drug semaglutide despite its failure underscore a shift toward an approach to the disease that weakens the brain as a system of complex pathways, similar to the transformation the field of cancer therapy has undergone in recent years, experts say.
Only two drugs are approved to slow Alzheimer’s: Eli Lilly’s Kisunla and Eisai and Biogen’s Leqembi. Both were shown to slow disease progression by approximately 30% by removing toxic amyloid plaques from the brain, but progress is being made in identifying other targets and strategies to stop the disease.
Globally, more than 55 million people suffer from dementia, and approximately 60% of these cases are caused by Alzheimer’s, defined by the presence of amyloid and tau proteins in the brain.
“All diseases of aging require combination therapy,” said Howard Fillit of the Alzheimer’s Drug Discovery Foundation, one of the experts at a recent meeting on Alzheimer’s disease who discussed this shift in research. Addressing just one route will not be enough.
Blood and genetic tests are being developed to accurately identify biomarkers of the disease, but most diagnoses require a lumbar puncture or an expensive positron emission tomography (PET) scan. Not all patients benefit equally from anti-amyloid treatments.
Some studies suggest that black patients may have more than one type of disease and that treating amyloid alone may not be enough. Other analyzes have shown that men do better than women, as do patients with lower levels of tau.
Studies are expected to show that patients treated in the early stages of the disease do better than those who already have cognitive decline.
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Cancer treatment, which once consisted of universal chemotherapy to eliminate fast-growing cells, has proliferated into a wide range of drugs targeting specific genetic mutations and other precise characteristics of malignant cells, in addition to immunotherapies.
David Watson, executive director of the Alzheimer’s Research and Treatment Center, said current research “is like oncology 20 years ago… It’s extremely exciting.” He cited advances in detecting blood biomarkers of tau, amyloid and other features of the disease, as well as the genetic basis of Alzheimer’s, as reasons for optimism.
Novo’s results “underscore a crucial shift toward the next era of drug development, which will focus on the many interrelated biological factors of this complex disease,” Fillit said.
Oral semaglutide provided no cognitive benefit in people with early-stage Alzheimer’s, but Novo will provide full details of the trial in March, including a likely breakdown of patient characteristics that could provide clues for others.
“We want to see more potential subgroup analyses,” including how the disease progressed in people treated at earlier stages, said Dawn Brooks, director of neurodegeneration development at Eli Lilly.
Lilly, maker of the best-selling tirzepitide GLP-1 drug marketed as Mounjaro and Zepbound, is still exploring whether this class of drugs has a role in Alzheimer’s, Brooks said. However, the Indianapolis-based company’s current GLP-1 brain health program focuses on alcohol and tobacco use disorders.
Kisunla and Leqembi, which require close monitoring due to the risk of brain inflammation, are being tested in people with Alzheimer’s who do not yet have symptoms. The Kisunla study is scheduled for 2027, and Lilly has noted that interim results could be published sooner.
With information from Reuters
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