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In a significant advancement for Alzheimer’s care, Health Canada has granted approval for Donanemab, marketed as Kisunla by Eli Lilly, a move heralded as a potential turning point for those in the early stages of the disease. This approval, announced on Monday, follows the drug’s endorsement by the U.S. Food and Drug Administration (FDA) in 2024 and marks it as the second treatment of its kind available in Canada, following the approval of lecanemab, known commercially as “Leqembi,” in October 2025.
A Breakthrough in Alzheimer’s Treatment
Both Donanemab and lecanemab function by targeting amyloid proteins, which accumulate in the brain and are associated with the onset and progression of Alzheimer’s disease. The presence of these amyloid plaques can significantly impair memory and cognitive function. Although Donanemab is not a cure, clinical trials suggest that it may slow the decline in cognitive capabilities for some individuals early in their Alzheimer’s journey. The Alzheimer Society of Canada has noted that initial findings are promising, with patients showing improvements in memory, thinking, and daily living skills.
In the trials, participants who received Donanemab were able to discontinue treatment once the amyloid plaques were eliminated, with some patients ceasing treatment within just six months and nearly 50% stopping after a year. The results indicate that those who were at an earlier stage of the disease experienced the most substantial benefits.
Clinical Trial Results
The data reveals compelling evidence regarding the efficacy of Donanemab. Over an 18-month period, participants in the earlier phases of Alzheimer’s saw a 35% reduction in cognitive decline as measured by the integrated Alzheimer’s Disease Rating Scale (iADRS). For the broader group of trial participants, the drug demonstrated a 22% slowing of disease progression. This reinforces the notion that timely intervention may significantly alter the course of Alzheimer’s for many individuals.
Alzheimer Society of Canada’s CEO, Christina Scicluna, described the approval as a “hopeful milestone” for patients and their caregivers, underscoring the importance of ongoing research and advocacy in the field. She remarked, “While not a cure, it shows how far we’ve come and why research and advocacy matter.”
Limitations and Future Steps
Health Canada has stipulated that Donanemab is to be administered only to adults who do not possess the APOE4 gene, a genetic variant that heightens the risk of developing dementia and is present in about 20% of the global population. Patients receiving this therapy may experience side effects, including amyloid-related imaging abnormalities (ARIA), which can manifest as temporary brain swelling.
Following this approval, Canada’s Drug Agency will evaluate whether Donanemab will be included in provincial and territorial drug plans. The Alzheimer’s Society of Canada has committed to advocating for public funding of the drug, although they caution that it may take up to two years for newly approved medications to be covered under public health plans. Those with private insurance or extended health benefits may find themselves able to access treatments more swiftly.
Why it Matters
The approval of Donanemab represents a crucial development in the fight against Alzheimer’s disease, offering hope to patients and families grappling with the challenges of early-stage cognitive decline. By potentially allowing individuals to maintain their independence longer, this drug may change the narrative surrounding Alzheimer’s, empowering patients and their caregivers to navigate this complex journey with renewed optimism. As the healthcare community rallies to advocate for equitable access to this promising treatment, the need for comprehensive support systems remains paramount to ensure that all patients can benefit from these advancements in care.
