New drug could be gamechanger for those with Alzheimer’s ... but you can’t get it in Canada

Heather Wright speaks with patients about their experience trying the new drug and the struggle of it not yet being approved in Canada.

Two drugs that have shown success in slowing the progression of Alzheimer’s disease are not available in Canada, which is now the only country in the G7 that has not authorized its use.

It’s leading to growing frustration for patients and care partners who are eager for new treatments.

“I think I either have to wait or go to the (United) States,” said Morley, who was diagnosed with mild Alzheimer’s disease three years ago. “That’s the dilemma we are in.”

Morley learned he had Alzheimer’s accidentally. He got a concussion after a fall while skiing and his wife encouraged him to see a specialist to make sure everything was OK. A PET scan revealed amyloids in his brain, a protein associated with Alzheimer’s, which were unrelated to his concussion.

“It was serendipitous that they took a PET scan,” he said. “I don’t think I would have found out otherwise.”

As with every disease, early detection and treatment is key. Morley has quit drinking, exercises regularly, eats well and tries to get as much sleep as possible.

“I’ve been diagnosed with a mild cognitive impairment, and I’d like to keep it like that, rather than get worse,” he said.

Two drugs, lecanemab and donanemab, have shown to slow disease progression and extend the independence of those living with early Alzheimer’s disease. Lecanemab has been approved in 44 countries including the United States, Australia and Japan.

“These new therapies bring new hope because they can actually modify what’s going on within the brain,” said Dr. Sara Mitchell, a neurologist at Toronto’s Sunnybrook Hospital who is co-leading the hospital’s dementia strategy. “They are the first treatments to be proven to do that after years, decades, of negative research.”

Mitchell says these therapies won’t cure Alzheimer’s but are a first and important step in finding better ways to treat the disease, rather than just managing the symptoms.

“We’ve had symptom-based therapies, but they aren’t doing anything to intervene in the underlying disease,” she said.

Instead, these drugs go into the brain and remove the amyloids. Data from clinical trials show patients had a roughly 30 per cent slower rate of decline compared to the control group that was given placebos. That equates to between five or six more months of independent living.

“For these patients to even hear that there is a possibility of new treatments, to hear that we are making progress … is really a beacon of hope,” Mitchell said. “It allows patients to think about a time when Alzheimer’s disease is more of a chronic disease opposed to this sentence that you are going to be losing your faculties for ever more.”

It’s not clear why it has taken Health Canada more than two years to review and approve these drugs. In a statement, Health Canada says it does not comment on the status of drugs under review but noted that medications are approved only if the benefits outweigh any potential risks.

There are side effects to both lecanemab and donanemab including nausea, headaches, and in some cases swelling and bleeding in the brain. According to the health journal JAMA, there were three deaths reported in the donanemab group clinical trial and one in the placebo group that were considered treatment related.

The drug is also expensive – in the United States the manufacturer is listing the cost of lecanemab at $26,500 per year and donanemab at $32,000 per year. The drugs are taken intravenously and require frequent brain scans for monitoring, an additional cost.

There is also concern about whether the cost is worth the impact. In the United Kingdom, the National Institute for Health and Care Excellence (NICE) rejected donanemab citing the “relatively small benefit” it provides. NICE notes there “is a large cost to providing the drug, which is administered by monthly infusions and needs to be intensively monitored for side effects.”

If approved, experts say it would not be for every patient and would only be prescribed to those in the early stages of the disease.

“I just think if there was any sort of treatment, any sort of new treatment, it just gives that glimmer of hope,” said Nick Lagace, whose mother Nicole was diagnosed with Alzheimer’s at age 53 in 2020.

Lagace says the disease has progressed too far for his mom to qualify for either of these medications if they were approved, but with a family history of Alzheimer’s, he’s hopeful they could be the start of improved treatment.

“When you get a devastating diagnosis of Alzheimer’s, the reason it has so much weight on families ... is because there is little hope,” he said. “Essentially it is a waiting game. A slow waiting game. It’s torture.”

As part of her work co-leading Sunnybrook’s dementia strategy, Mitchell wants to see a shift in how Alzheimer’s care is approached. While that includes new drug treatments, she says education and early intervention are also key.

“Once you get clinical symptoms, the truth is it may be too late to really meaningfully intervene in a way that we want to,” she said, noting 14 risk factors for the disease that can be modified by lifestyle changes. They include inactivity, smoking, excessive alcohol consumption, air pollution, head injury, social isolation, education, obesity, hypertension, diabetes, depression, hearing impairment, untreated vision loss and elevated cholesterol.

“Many people when they hear dementia only think about that last stage,” she said. “What we really need to think about is people who are experiencing this disease really early on and all the things we can do both as a health-care system, but also on the individual level that we can do to affect change and modify our brain health as we face aging.”

It’s why Morley is doing everything he can to live a healthy life, while encouraging others to listen to any symptoms they might have and seek help as early intervention is key.

“Early treatment, getting in there, talking about it, getting over the fear and anxiety,” he said. “Having partner and family help, all of this matters in terms of how well you’re going to do.”

“There is a stigma out there in our society,” adds Margot. “I think people are perhaps a bit reluctant to go in and talk to their doctors.”

The Alzheimer Society of Canada predicts by 2030, there will be nearly one million Canadians living with dementia, the umbrella term for symptoms caused by brain disorders that impact memory and cognitive thinking, including Alzheimer’s disease. With an aging population, experts want more funding and research to go to ways to prevent the disease and detect it earlier.

“There is a lot of work that needs to be done to reconceptualize that Alzheimer’s disease is a disease of the brain,” says Dr. Mitchell. “It can affect people in their 50s, in their 60s, and we need to be thinking about it earlier in life.”