Alzheimer’s drug that showed significant difference in early trials approved for use in Canada

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A drug that may slow progression of dementia in some patients has been approved for use in Canada, the manufacturer announced.

Donanemab is the “first and only amyloid plaque-targeting therapy with evidence supporting stopping treatment once amyloid plaques are cleared,” Eli Lilly Canada Inc. said in a statement announcing the approval Monday.

Clumps of the protein amyloid may lead to cognitive and memory problems typically linked to Alzheimer’s, the drugmaker said. Donanemab helps the body remove this buildup.

The drug was already approved by the United States and European Union and sold under the name Kisunla.

The monthly treatment is now available for some Canadians with early symptomatic Alzheimer’s disease, Eli Lilly Canada said.

‘This drug is not a cure’

Early research on the drug was promising for some, with nearly half of participants showing no clinical progression of dementia in the first year of use, the Canadian organization Alzheimer Society wrote in a previous update on the approval process.

Progress was measured using a common diagnostic tool that assesses memory and other dementia indicators.

“Yet this drug is not a cure,” the Alzheimer Society wrote in 2023.

Eli Lilly said some participants of its trials were able to stop the treatment within as little as six months.

While initially billed by some as a major breakthrough, the overall efficacy of targeting amyloid buildup has been questioned after a sweeping review of available research.

Not ‘clinically meaningful’

In a summary of trial data, the Alzheimer Society noted 29 per cent of people on a placebo showed no clinical progress compared to 47 per cent of those on donanemab, the drug worked better for some than others and trial groups were not ethnically diverse, along with other concerns.

Last month, the Cochrane organization released results of an extensive review looking at donanemab and another Alzheimer’s drug called lecanemab. The review of existing research indicated the treatments may not actually translate to “something clinically meaningful for patients,” the study’s lead author said at a news conference, as reported by AFP.

The report suggested that the drugs did successfully remove amyloids, but that removal may not actually benefit patients in a clinically significant way.

While the Cochrane organization is known for its comprehensive research reviews, its anti-amyloid report was criticized by scientists including the biologist who first hypothesized the impact of amyloid removal.

John Hardy called it a “silly paper” in an interview with AFP, and cautioned against drawing conclusions from averages taken from multi-drug studies, but disclosed he had consulted with the manufacturers behind the drugs studied.

Neuroscientist Bryce Vissel told AFP that the research shows the drugs may not deliver results initially heralded as groundbreaking, but it doesn’t disprove the role of amyloid in the progression of Alzheimer’s, nor does it rule out that future treatments might help patients.

Eli Lilly said more than 770,000 Canadians were living with Alzheimer’s disease as of 2025.

With files from AFP