Health Canada Approves Lecanemab

On October 25, 2025, Health Canada approved lecanemab (brand name Leqembi®) to treat people with a clinical diagnosis of mild cognitive impairment or early-stage Alzheimer's disease (mild dementia due to Alzheimer's disease) who are apolipoprotein E ε4 (ApoE ε4*) non-carriers or heterozygotes and who have confirmed amyloid pathology. This is the first disease-modifying Alzheimer's treatment approved for use in Canada.

The Alzheimer Society of Canada supports Health Canada's decision to authorize lecanemab (U.S. brand name Leqembi) as a treatment for people diagnosed with mild cognitive or early-stage Alzheimer's disease. We respect the careful and thorough process used by Health Canada to assess the safety, efficacy and tolerability data for lecanemab.

This marks a historic moment in Alzheimer's disease treatment. Lecanemab is the first medication in Canada shown to slow the progress of Alzheimer's disease and address its underlying biology. Despite this approval, lecanemab could still take over a year to become accessible through private drug plans and more than two years through public plans. This underscores the critical importance of receiving a timely diagnosis, as the medication is effective only for those in the earliest stages of the disease. To ensure a comprehensive understanding of its impact, it will be important to establish patient registries for collecting real-world evidence on the efficacy and safety of lecanemab. These registries should focus on outcomes that are meaningful for individuals living with Alzheimer's disease and their care partners. Ongoing monitoring will be essential to assess the medication's real-world effectiveness.

Further, while this marks a significant step forward, lecanemab will not be suitable for everyone once it becomes available. This includes individuals in the later stages of Alzheimer's disease, those with specific conditions (such as stroke or bleeding, immunologic or seizure disorders), and people with other forms of dementia. It is important to note that this medication is not a cure and cannot reverse the progression of Alzheimer's disease. As with any treatment, some individuals may experience side effects, including potentially serious ones. It is important to consult with a health-care provider before starting any new treatment to ensure it is appropriate for your specific health condition and needs.

According to the World Alzheimer Report 2024 by Alzheimer's Disease International, over 90 per cent of respondents said they would pursue a dementia diagnosis if they knew a disease-modifying treatment was available. It is the hope of the Alzheimer Society of Canada that as treatments become available, people will be encouraged to seek a diagnosis of dementia earlier.

The approval of lecanemab marks a significant milestone in dementia research but also highlights critical gaps in Canada's current health-care infrastructure. 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. Currently, accessing lecanemab requires specialized diagnostic tools, such as an amyloid PET scan or lumbar puncture, to confirm eligibility. The medication is administered through intravenous infusion, and ongoing monitoring, typically via PET scans or MRIs, is necessary to ensure safety and effectiveness. Meeting these demands will require substantial investments in human resources, infrastructure, training, and the creation of new health-care pathways to deliver such treatments effectively and equitably.

With other promising treatments on the horizon, the Alzheimer Society of Canada has hope that lecanemab can serve as a baseline to which we compare future treatments. The Alzheimer Society of Canada continues to advocate for increased research funding for dementia to develop, test, and approve new treatment breakthroughs in the future. We also urge for broader and more equitable access to dementia risk reduction resources, diagnosis tools, symptom management, and care support. This ensures that all people living with dementia, and their care partners, can maintain a good quality of life and access appropriate interventions in a timely manner.

Download and read our full position statement (PDF).

What is lecanemab?

Lecanemab is an intravenous monoclonal antibody treatment that removes amyloid plaques (a protein often connected to Alzheimer’s disease) from the brain. This drug is not a cure. It is designed to slow the progression of Alzheimer's disease.

Who is lecanemab intended for?

The drug is only approved to be used in people with mild cognitive impairment or mild (early-stage) Alzheimer’s disease.

The drug is not supposed to be used for people at moderate or later stages of Alzheimer’s disease. This drug should not be used to treat people with two copies of the APOE4 gene. People with two copies of the APOE4 gene have a significantly higher chance of developing side effects called "amyloid-related imaging abnormalities", or ARIA (swelling and bleeding in the brain). Learn more about genetic testing for Alzheimer's disease.

This drug is also not supposed to be used for any other form of dementia–only for dementia related to Alzheimer’s disease.

How is lecanemab administered?

This drug is to be taken intravenously twice a month. This drug will also require frequent brain scans for side-effects monitoring.

What are some of the major side effects of lecanemab?

Major side effects of lecanemab in the latest study included brain swelling in 12.6% of study patients, and brain bleeding in 17.3% of study patients. Note: It is important to tell your doctor if you are taking anticoagulants (blood thinners), which may increase the risk of brain bleeding in people taking lecanemab.

The New England Journal of Medicine study from November 2022 also reported that 6 people died while taking lecanemab – this is slightly less than the 7 people who died taking the placebo.

The Alzheimer Society of Canada support full investigations of all fatalities that occur during drug trials.

How much does lecanemab cost? Will the cost be covered by provincial/territorial health plans?

In the United States, one of the drug's makers, Eisai, has set the price at $26,500 USD annually. In Japan, the price is roughly $20,500 per year.

Health Canada allows the medication to be marketed and sold within the guidelines set out by Health Canada and the manufacturer.

It is still unclear how much lecanemab will cost in Canada. It is important for people in Canada to know that it may take time for provincial and territorial health authorities to decide whether the drug will be covered under their health systems.

If you have extended health-care coverage, we suggest that you check with your coverage provider to find out if lecanemab is covered under your plan.

After lecanemab is approved, how soon will it be available?

Availability of lecanemab may vary depending on the province or territory that you live in. Despite this approval, lecanemab could take over a year to become accessible through private drug plans and more than two years through public plans.

When available, how can I request lecanemab?

A timely diagnosis of dementia offers many benefits, including better access to treatment options and support, ability to plan for the future, and more meaningful time with family and friends. Learn more about getting a diagnosis.

If you are interested in taking this medication, ask your health-care provider if this medication is right for you.

Health-care providers can provide an accurate assessment of your symptoms and provide a diagnosis to determine if you can be treated with lecanemab. An assessment might include brain scans, a cerebrospinal fluid test and APOE4 genetic testing. Ask your health-care provider for more information about the assessment and testing procedures. Learn more about genetic testing for Alzheimer's disease.

What does the research show about the effectiveness of lecanemab?

A New England Journal of Medicine's study found that lecanemab "resulted in moderately less decline" of thinking and function in people with early Alzheimer's disease when compared to a placebo.

Specifically, study researchers found that lecanemab slowed cognitive decline by 27% compared to placebo over 18 months.

In other words, cognitive decline – that is, thinking and memory getting worse – still did happen in people who took lecanemab. But that decline was statistically slower than in people who took a placebo.

Study researchers also found that lecanemab lowered the amount of amyloid in people's brain. Amyloid is a protein often connected to Alzheimer's disease.

What major concerns have emerged from the research on lecanemab?

A December Lancet editorial aimed at "tempering hype and hope" around lecanemab said that the research results so far "might not be clinically meaningful."

Those editorial writers looked more closely at the cognition test the New England Journal of Medicine's study used, called the CDR-SB. The writers pointed out that the total impact of lecanemab on cognition amounted to "a 0.45-point difference on … an 18-point scale."

Do researchers believe more studies of lecanemab are needed?

Yes. In November 2022, the New England Journal of Medicine's study researchers called for "longer trials" of the drug to find out whether lecanemab is safe and effective to use in early Alzheimer's disease.

There are other major clinical trials going on right now internationally on lecanemab. Those trials should finish between 2025 and 2031, providing more data about the drug.

How can I, or someone I know, participate in dementia drug trials and research studies in Canada?

If you or someone you know is interested in participating in a clinical drug trial or clinical treatment trial, there are a few different options.

You can find information about clinical trials internationally at clinicaltrials.gov. Some of these trials will have Canadian sites.

You can also find many Canadian dementia studies, and some clinical trials, to participate in at alzheimer.ca/find-studies.

You can also ask your doctor, neurologist or other dementia specialist about trials or studies they might know of or be involved in.

Questions about lecanemab and other drugs

What is the same between lecanemab and donanemab?

Both drugs are administered intravenously.

Both drugs use antibodies to try to remove amyloid from the brain.

Lecanemab and donanemab are available in the United States for the foreseeable future.

What is different between lecanemab and donanemab?

Lecanemab is made by the drug companies Biogen and Eisai. Donanemab is made by Eli Lilly and Company.

According to research studies, lecanemab slowed cognitive decline by 27% compared to placebo over 18 months, whereas donanemab slowed cognitive decline by 22.3% compared to placebo over 18 months.

What major concerns have been raised about monoclonal antibody drugs for Alzheimer's disease?

Accessibility is a significant concern surrounding monoclonal antibody drugs like donanemab and lecanemab. These drugs are taken intravenously monthly or twice monthly which requires access to specialized health-care facilities and transport to and from them.

These drugs also require frequent brain scanning to monitor effectiveness and safety.

Researchers point out that some health-care services such as intravenous infusion and brain scans are often unavailable in under-resourced communities.

Other researchers note that, at best, these treatments can only be considered for certain people with Alzheimer's disease. And that also, even within this group, people with high tau levels may not benefit.

What else should I know about the field of dementia drug development right now?

There are now more than 138 dementia drugs in development internationally. A major push in the drug development field is to find drugs that treat underlying causes of dementia, not just dementia symptoms. Four other drugs are approved in Canada to help manage the symptoms of Alzheimer's disease, and these drugs have been used for many years for that purpose. You can read about them on our webpage: Medications approved to treat Alzheimer's disease in Canada.

If you have any questions about dementia drugs and access to them, contact your regional Alzheimer Society team using the information at alzheimer.ca/find, or reach our national information line at info@alzheimer.ca or 1-855-705-4636.

Including living/lived experience of dementia in lecanemab reviews

During May-July 2024, the Alzheimer Society of Canada developed an online survey to gather the experiences of people living with Alzheimer's disease or mild cognitive impairment (MCI) due to Alzheimer's disease, and their caregivers, and those who were involved in clinical trials of Leqembi (lecanemab) and/or donanemab. The results of this survey (see links below), were submitted to Health Canada to ensure that the voices of people with living/lived experience are represented and considered during the review process.

Alzheimer Society of Canada submission - CADTH Reimbursement Review Patient and Clinician Group Input lecanemab (Leqembi)

Alzheimer Society of Canada submission - CDA-AMC Reimbursement Review Patient and Clinician Group Input donanemab

More information and resources

Use of new medications for Alzheimer's disease in the Canadian healthcare system by the Canadian Consortium on Neurodegeneration in Aging (CCNA). Frequently asked questions (and answers) about new medications for Alzheimer's disease that may be made available in Canada in the future.

Last updated: October 2025