Exciting news has emerged from recent clinical trials of Lecanemab, an experimental Alzheimer’s drug developed by pharmaceutical companies Eisai and Biogen. The results demonstrate that Lecanemab significantly slows cognitive decline in early Alzheimer’s patients and even shows signs of reversing disease progression by removing amyloid plaques that are hallmarks of the disease.
Lecanemab Trial Shows Cognitive Improvement, Plaque Reduction
In the Phase 3 clinical trial results announced in late 2022, Lecanemab met every primary and secondary goal. Alzheimer’s patients given bi-weekly infusions of the drug over 18 months declined more slowly on clinical tests of cognition and daily function compared to patients given a placebo.
Additionally, PET scans revealed that the drug clearly removed amyloid beta plaque buildups in patients’ brains:
| Plaque Reduction Results | Lecanemab Group | Placebo Group |
|---|---|---|
| Average Plaque Reduction | 0.306 SUVr units | 0.008 SUVr units |
| Percentage with Plaque Reduction | 91% of patients | 8% of patients |
Based on these highly promising findings, the FDA is expected to approve Lecanemab for widespread use under an accelerated timeline in early 2023.
Dr. Gregory Jicha, a professor of neurology at the University of Kentucky, described the Lecanemab results as a “gamechanger” for Alzheimer’s treatment:
“To actually see evidence not only of plaque removal but hints of actual cognitive benefits I think is very exciting and holds great promise.”
Brain PET scan showing amyloid plaque deposits (orange) before and after Lecanemab treatment. (Image credit: Penn Medicine)
First US Patient Receives Lecanemab Infusion
On December 15th, 2022, the first Alzheimer’s patient in the United States outside of a clinical trial setting received an infusion of Lecanemab at Atrium Health Wake Forest Baptist medical center in Winston-Salem, NC.
82-year old Kim Cuevas was selected by her doctors for the groundbreaking treatment based on her early Alzheimer’s diagnosis earlier in 2022. Cuevas and her family hope the new drug will slow her cognitive decline after witnessing the debilitating progression of the disease in other relatives.
Dr. James Galvin, who administered the first infusion, tempered expectations but called Lecanemab a “cautiously optimistic” breakthrough for Alzheimer’s patients:
“It’s incredibly hopeful but also incredibly humbling because there’s so much work still to do…We have to ensure access to the communities that need it the most while also realizing this isn’t a cure.”
The promising early results with Lecanemab bolster other recent research that suggests Alzheimer’s may become a treatable, even curable disease in the coming decades.
Additional Developments Raise Hopes for More Alzheimer’s Treatments
Alongside Lecanemab, optimism among Alzheimer’s experts has grown recently thanks to several other experimental treatment breakthroughs:
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In early 2023, the journal Nature published a new study showing that a protein regulating molecule called a “chemical chaperone” reversed symptoms of dementia in mice genetically engineered to mimic Alzheimer’s. After just four weeks of chaperone treatment, the mice’s memory was restored to normal function. Researchers believe regulating protein homeostasis in human Alzheimer’s patients may achieve similar benefits.
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Scientists at the University of Oxford achieved promising results with an immunosuppresant drug called Mirococept that reduced neuroinflammation and synaptic dysfunction in early-stage Alzheimer’s patients during a phase 2 clinical trial concluding in late 2022. By modulating the body’s immune response, the drug showed signs of protecting neurons from further damage.
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In December 2022, researchers at the University of Pennsylvania Perelman School of Medicine published a new study showing their gene therapy treatment aimed at removing amyloid plaque could reverse memory loss and neuronal damage in mice engineered to mimic progressive, later-stage Alzheimer’s disease. This provides hope that combining treatments like Lecanemab with gene and immunotherapies could provide greater benefit than single drugs alone.
PET brain scan showing amyloid plaque removal after gene therapy treatment in mice (Image credit: Penn Medicine)
While all these treatments still need to demonstrate efficacy in human trials, researchers believe Alzheimer’s will likely require a combination therapy approach with drugs like Lecanemab complemented by anti-inflammatory and gene therapies. Most experts caution that preventing plaque buildup with Lecanemab early in disease progression will be key.
What Comes Next? Improving Access and Affordability
With the FDA expected to approve Lecanemab in early 2023 based on trial results, attention now shifts to issues around access and affordability.
As a complex biologic therapy requiring regular IV administration, Lecanemab treatment will be expensive. Analysts forecast over $20,000 per year for the recommended 10mg/kg infusion every 2 weeks. With 5 million Americans diagnosed with Alzheimer’s, costs could quickly spiral to tens of billions under the current healthcare system.
To ease affordability concerns, Biogen announced in 2022 that they expect to set a “value-based” price for Lecanemab pending FDA approval that factors in long-term savings from delaying nursing home care. However, patients and advocacy groups worry that without changes to Medicare coverage policy, access may still be restricted by out-of-pocket costs.
In clinical trials, around 17% of Lecanemab patients experienced side effects like brain swelling and bleeding compared to only 8% on placebo. So regulators and doctors will need to determine strict monitoring guidelines as the drug becomes more widely available.
Despite outstanding questions, the latest results represent a true breakthrough moment for Alzheimer’s treatment after decades of research frustrations. 2023 may usher in a new era of cautious optimism for improving life for Alzheimer’s patients. But continued progress relies on learning how to best combine Lecanemab with emerging gene, immune, and other therapies for maximum impact on this devastating disease.
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