Who is a candidate for lecanemab (and how to get the treatment if you qualify)?

Last updated: 28 August 2024

Who is a candidate for lecanemab (and how to get the treatment if you qualify)?

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After decades without a new treatment option for Alzheimer's, Leqembi (lecanemab) brought hope to early dementia patients by getting its FDA approval in 2023. Interest towards the medicine has been considerable since then, regardless of mixed signals from the EMA about its approval.

If you're also wondering whether lecanemab could be a treatment option for you or a loved one, here are some things to consider.

What is lecanemab approved for?

Leqembi (lecanemab) is currently only approved in the USA and the UK, for the treatment of early-stage Alzheimer's disease 1, 5. Before starting a treatment, the presence of amyloid beta plaques must be confirmed.

Starting treatment early may be beneficial

Recently reported results from the Phase 3 Clarity AD trial suggest that lecanemab may be more effective in slowing down disease progression when treatment is started early.

To arrive at this conclusion, researchers looked at the tau pathology of clinical trial patients. Lower levels of tau indicate earlier disease stage and less disease progression. Patients were split into a "low tau" group and an "intermediate/high tau" group, and results compared between them, with the most notable outcomes being:

  • At the 18th month mark, 93% of the "low tau" group patients reached low enough levels of amyloid plaques to be considered normal. In comparison, 57% of the "intermediate/high tau" group achieved this result;
  • The "low tau" group showed a numerically greater slowing of cognitive decline than the "intermediate/high tau" group, as measured by standardized scores 2.

These outcomes can be interpreted as evidence in favor of starting lecanemab treatment very early on. In fact, a phase 3 clinical trial is currently evaluating the potential efficacy of Leqembi in preclinical Alzheimer's patients, whose cognitive performance is still intact. The study will conclude in 2029 3.

How do you qualify for lecanemab?

Although early stage Alzheimer's seems like a clear enough criterion to qualify for treatment with Leqembi, it's not as straightforward.

As is often the case with new medicines, patients need to meet the same qualification criteria that were used in the clinical trial preceding the medicine's approval. In lecanemab's case, these criteria are:

  • age between 50 and 90;
  • a confirmed presence of beta-amyloid plaques;
  • mild cognitive impairment or mild dementia due to Alzheimer's disease;
  • Body mass index (BMI) between 17 and 35. This criterion may be related to the association of higher body mass during midlife with an increased risk of dementia, including Alzheimer's disease 4.

Who should not take lecanemab?

Certain individuals may not qualify for treatment with Leqembi. Including those with cardiovascular disease, stroke history, cancer, or brain scans showing previous small brain bleeds or injuries.

Additionally, patients with cognitive impairment not due to Alzheimer's disease or a BMI outside the specified range may not be eligible.

On a more practical level, the administration of Leqembi can also pose a challenge for some patients. Leqembi currently requires intravenous infusions every couple of weeks, which need to be administered by a medically trained professional. This can make it practically impossible for some patients to get the treatment. Until lecanemab can be injected at home, doctors may be hesitant to prescribe it to patients in remote locations or with mobility impairments.

Are you unsure whether you qualify for lecanemab treatment? With the recent data showing the benefits of an early treatment start, it's more worth it than ever to have an open discussion with your doctor. Even more so if you have a history of Alzheimer's in your family.

In the end, qualification criteria are important, but other factors such as your family history and health condition may be more impactful for your doctor in making a decision to prescribe Leqembi or not.

How can you get lecanemab outside the USA and the UK?

Maybe you're wondering what the point is of discussing lecanemab with your doctor if you're based outside the USA or the UK - the only countries where the medicine is approved. Luckily, you can get the treatment anyway, as long as your doctor prescribes it.

This is possible thanks to the Named Patient Import regulation applicable in most countries. It allows individual patients to buy and import a medicine for their personal use, if there are no alternatives locally, and the medicine can address a serious condition.

Do you qualify for lecanemab, and has your doctor prescribed it? Get in touch with our team at Everyone.org. We'll support you in buying lecanemab before it's approved or available in your country.

 

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References:

  1. HIGHLIGHTS OF PRESCRIBING INFORMATION. Leqembi, . Accessed 10 May 2024.
  2. AD/PD 2024: Leqembi data supports early treatment initiation for better outcomes. Clinical Trials Arena, Accessed 10 May 2024.
  3. AHEAD 3-45 Study: A Study to Evaluate Efficacy and Safety of Treatment With Lecanemab in Participants With Preclinical Alzheimer's Disease and Elevated Amyloid and Also in Participants With Early Preclinical Alzheimer's Disease and Intermediate Amyloid. ClinicalTrials.gov, Accessed 10 May 2024.
  4. Amyloid-beta burden predicts prospective decline in body mass index in clinically normal adults. Neurobiology of Aging, Accessed 10 May 2024.
  5. Lecanemab licensed for adult patients in the early stages of Alzheimer’s disease. Gov.uk, Accessed 28 August 2024.