Approval of new Alzheimer’s drug in Canada called historic

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The approval of a new drug that can slow the progress of

Alzheimer

’s disease is being hailed as a historic moment in the treatment of a disease projected to affect one million Canadians by 2030.

The drug, lecanemab, was approved by Health Canada this week. It is the first treatment available in Canada to focus on the underlying condition and not its symptoms. The treatment could be available to some Ottawa patients with mild cognitive impairment within a matter of months.

But amid excitement about long-awaited progress in the treatment of Alzheimer’s disease, there is some caution. Lecanemab is one of a group of drugs known as anti-amyloid therapies that may slow the progression of Alzheimer’s, but also carry serious risks for a small percentage of patients. Those risks include brain swelling and brain bleeds.

That is part of what will make treatment with the drug complicated, said Dr. Andrew Frank, a cognitive neurologist and researcher at Bruyère Memory Program at Bruyère Health in Ottawa.  Bruyère hopes to be among the first locations in the region to make the treatment available to those who qualify, he said.

The drug is administered intravenously every two weeks, said Frank. It is composed of antibodies that cross through to the brain and stick to amyloid, a protein whose buildup is associated with Alzheimer’s disease. Doing so allows it to be cleared by the body’s immune system.

Clinical trials suggest the treatment can slow the rate of deterioration from Alzheimer’s by 27 per cent. The rate can be higher if the treatment is given earlier in the progression of the disease.

Because of the potential risks, patients must be assessed for eligibility and then monitored closely, including with MRIs and blood tests. Frank said a blood test is available, although not publicly funded, which can confirm whether amyloid is present. It could eliminate the need for a PET scan to check for the presence of amyloid in the brain prior to treatment.

About three per cent of people being treated will experience major side-effects, including swelling and bleeding of the brain. That can cause headaches, dizziness or stroke-like symptoms.

The risk-benefit calculation, as well as its cost, has made the treatment controversial among some. Frank said risks must be considered carefully by potential patients, “and may influence an individual’s decision to consider this treatment when balanced with its potential benefit.”

But he applauded Health Canada’s decision to approve the treatment, saying it will give Canadians a choice.

“It represents the first new treatment for Alzheimer’s disease in Canada in 20 years. It is not a cure, but it does slow the condition, which may translate into more time doing things that we enjoy and more time with loved ones.”

The drug is not yet covered by provincial drug plans and is expected to be expensive. In the U.S., it costs upwards of $26,000 for one year. Treatment often takes 18 months or more.

Frank said planning is underway at Bruyère’s memory clinic to initiate the treatment in Ottawa. That would include assessing individuals to determine whether they would qualify and monitoring patients. Infusions would likely take place in the community, he said.

“We are hoping to offer it to those individuals who would most benefit.”

Bruyère was the site of a clinical trial for another anti-amyloid treatment for Alzheimer’s, known as donanemab. It is likely to be approved soon by Health Canada, Frank said.

“My hope is that today’s approval is the first of many disease-modifying therapies for Alzheimer’s disease and that incrementally we will one day reach a place in which we can powerfully prevent the expression of dementia in our society.”

Dr. Saskia Sivananthan, a neuroscientist specializing in dementia, said whether to undergo the treatment will be a personal choice for those who are eligible, but the new treatment offers “a way in which people can approach a disease like Alzheimer’s with more hope.”

With more progress expected when it comes to the treatment, testing and management of Alzheimer’s, Sivananthan said Ontario needs a more coordinated infrastructure for dementia, similar to the province’s approach to cancer. Sivananthan is the founder and CEO of Brainwell Institute, a dementia-focused think tank.

The Alzheimer Society of Canada said approval of the drug marks a significant milestone in dementia research, but also highlights critical gaps in Canada’s current health-care infrastructure. Among other things, it usually takes two years to get a diagnosis.

“To fully realize the benefits of this treatment and future innovations, the health-care system must be equipped to provide timely diagnoses, equitable access to high-quality care, and robust support for individuals living with dementia.”

Frank thinks the number of patients receiving treatment will be small at first. But, over time, he expects more people to be motivated to get their memory checked earlier, knowing that there is a possible treatment.

“We now have a new form of treatment of Alzheimer’s, which is best used in the earliest stages. If an individual has memory concerns about themselves or a loved one, it is helpful to reach out to a family physician for a cognitive assessment and, if needed, a referral to a memory centre for further evaluation.”

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